Offering Hope and Help to the Victims of ARD Worldwide

Government ...Pile of Bile: 

Index


 
1.) Communications with Dr. Frank A. Hamilton, M.D., M.P.H. Chief, Digestive Diseases Program, NIDDK Division of Digestive Disease And Nutrition

Bev's letter to the Dr. Frank A. Hamilton National Institue of Health, January 7, 2002 

January 7, 2002

Beverly J. Doucette
International Adhesion Society
Patient Advocate
Marinette, Wisconsin 54143

Dr. Frank A. Hamilton, M.D., M.P.H.
Chief, Digestive Diseases Program,
NIDDK Division of Digestive Disease 
And Nutrition
Dept. of health & Human Service
2 Democracy Plaza
Room 669, 
Bethesda, MD, 20892 
phone: (301) 594-8877

Subject: ICD9-CM Code for 
“APPLICATION OF AN ADHESION BARRIER for PREVENTION of ADHESIONS”
Centers for Medicare and Medicaid Services

My name is Beverly Doucette (aka Bev).  I am an Independent Patient Advocate for people who suffer the indignities of post surgical adhesions.  I would like to thank the Centers for Medicare and Medicaid Services for taking the initiative to recognize and question the impact of Adhesion Related Disorder(ARD) in the United States.  As a person, who sufferers from the consequences of post surgical adhesions - as well as having had 7 operations for adhesion-related conditions - I am well aware of the need for an ICD9-CM code for the "APPLICATION OF AN ADHESION BARRIER for PREVENTION of ADHESIONS." 

I am also very aware of the increase in the incidence of post surgical adhesions and the impact it is having in our society today! I am not going to take the time to share my personal struggle with Adhesion Related Disorder (ARD); because I think you are familiar with the symptoms and struggles of ARD sufferers as they exist in our country today. My story is no different than the ARD stories of others; so rather than share my story with you, I prefer to share what I think will benefit those affected by ARD.

I have assisted other ARD sufferers throughout the world in their search for the highest quality medical intervention available to them;  and what I have learned, will offer you a better understanding of why securing this ICD9-CM code is so vitally important! Considering my personal experience with ARD and my background as a registered nurse, I understand and recognize the need for the ICD9-CM code. If I understand the need for this code, you can be assured that other citizens of the United States understand it as well;  and they are questioning why an ICD9-CM code has not been established sooner - to afford them the opportunity to secure the highest quality medical intervention available in this country. Yet, because this ICD9-CM code did not exist, they have been denied the opportunity to get as well as one might get while suffering from ARD. I am of the opinion that this is an inexcusable act of negligence by the U. S. Government. It is impossible for this to be an oversight; because the sheer magnitude of information within the U. S. Government - regarding post surgical adhesions - is staggering.

It has been my experience that the United States seriously lags behind many other countries in recognizing the impact ARD has on our society;  and it has made no effort to decrease the ever- rising costs associated with the numbers of repeated surgical procedures being performed by surgeons for post surgical adhesions. The failure to recognize adhesiolysis procedures as being one of the most commonly performed surgical procedures performed in the USA today, leads to a lack of responsible medical intervention for the victims - whose lives are impacted by adhesions; and it deliberately  imposes ever-rising medical costs on taxpayers!

I have communicated with people from the Ukraine, who are able to present to a medical care provider and receive recognition of the disabilities that ARD causes. This same recognition of ARD is evident in other countries throughout Europe.  The recognition of ARD allows the use of adhesion barriers in surgical procedures for ALL citizens of  countries such as the Ukraine, Germany, the Netherlands, Sweden, Belgium, Australia - as well as many other countries where medical care is provided through the government. 

Those same ARD sufferers have the opportunity to receive a much better quality of medical intervention than their counterparts here in the so-called "progressive" USA. The recognition of post surgical adhesions as a disabling disorder - and taking the initiative, at the very least, to assume responsibility for ARD in these other countries - offers these countries the opportunity to reduce the incidence of repeated surgery for adhesions. As a result, these countries are able to reduce personal suffering from adhesion related disorder;  and ultimately they are able to offer a reduction in medical costs to their government.

[ BEV:  Upon request, I can submit substantiation of this information.]

As a taxpayer, I hold not only the Centers for Medicare and Medicaid Services (CMS) - but also other departments (who have anything to do with healthcare) within the U. S. Government - responsible for their awareness of the reasons for the rapidly rising costs of healthcare in this country.  The responsibility is theirs to provide the highest quality medical intervention available today for our citizens when it is available!

Post surgical adhesions create an increasing burden on our tax dollars.  We know that all too well. I am sure that the rising cost of healthcare is one of the issues the CMS is taking into consideration - as the CMS ponders the necessity for this IDC9-CM code.  You are to be commended in recognizing this - as well as taking the initiative to secure that code in the USA for the sake of increasing the quality of life for our citizens!  Surgical intervention with the use of adhesion barriers could very well be the answer to reducing costs incurred by so many repeated surgeries.

It remains a curiosity to me - and a bit of a sore spot - that the incidence of adhesion formation as the direct result of certain surgical procedures and the increasing number of those surgeries has been recognized within the medical arena for many decades.  Yet, no IDC9-CM code exits to recognize adhesions as being the major medical problem that they are;  and there is no ICD9-CM code to diagnose them. 

Bev:  Take a look at the following report - which dates back to 1932 - regarding a study done on post surgical adhesions!  Then review the medical reports issued years later...
1.) POSTOPERATIVE ADHESIVE INTESTINAL OBSTRUCTION

Dr. Ketan R Vagholkar, practicing Surgeon  Fracture and Accident Hospital, Thane-400602

Vick, in 1932, reported that adhesions accounted for 7% of all cases of intestinal obstructions.(35)   During the last few decades the leading cause of intestinal obstruction was strangulated external hernia.  The overall incidence of adhesive intestinal obstruction is 30% as shown in studies conducted by Nemir, Perry, Bevan and McEntree, (2), (23),(26)  Subsequent studies have revealed a steady rise in the incidence of intestinal obstruction to the present day incidence of about 40%. (2)

INCIDENCE:
Various studies have been carried out to assess the severity of problems posed by adhesions. Webel and Majno carried out a study in a post mortem series to find out the incidence of adhesions. (21, 22)  In cadavers with no preceding abdominal surgery, adhesions were found in 28% and in those that had minor abdominal surgery 67% had adhesions.(21, 22) With other abdominal surgery the report incidence was 50%. If major surgery had been performed, adhesions were present in 76% and in cases of multiple surgery 93% had adhesions. (18)

Ref:  POSTOPERATIVE ADHESIVE INTESTINAL OBSTRUCTION - Dr. Ketan R. Vagholkar, practicing Surgeon Fracture and Accident Hospital, Thane-400602
[ Bev:  Full report available.]
 

Bev:  When we look at the above medical report about adhesions - and we look at more recent reports on the incidence of adhesions (included below) - be the etiology due to post surgical or traumatic adhesion formation, the real issue here is that there have been NO changes in these reports that would reflect action on the part of those who sit in government positions.
Government officials could have intervened and created changes in the best interest of people who suffer adhesions. As the result of no change, the cost to the U.S. Government has been staggering, which equates to lack of concern by government officials in how OUR tax dollars are spent!

In fact, the only change that has occurred - within the time span of the reports that I have included in this letter - was that the incidence of surgeries in the United States increased! Specifically, the increase of surgeries - that resulted in adhesion formation and reformation of adhesions - increased enough so thatadhesiolysis procedures rival appendectomies, hip replacements(and though I only surmise this, adhesiolysis procedures are probably performed MORE than tonsillectomies!)

All anyone needs to do - even the untrained medical person - is to review the material in this letter; and they will be able to conclude that it is only common sense to secure this ICD9-CM code.
(There are a total of 10 reports - included in the above report.)


Bev:  Let's take a look at a few more medical reports regarding the incidence of surgeries that lead to adhesion formation.  In the following report NOT ONE WORD is mentioned about post surgical adhesions!!

2.) AHCPR Funding Studies on Hysterectomy vs. Alternative Treatment for Uterine Conditions

Press Release Date:  October 31, 1996

The Agency for Health Care Policy and Research (AHCPR) today announced the start of three research projects to determine the outcomes of surgery versus other treatments for dysfunctional uterine bleeding (DUB), as well as patient treatment preferences for women with endometriosis, chronic pelvic pain, fibroids, uterine prolepses or DUB.

Each year in the United States, 590,000 women have hysterectomies for various conditions. The majority of hysterectomies are performed before menopause, often for abnormal uterine bleeding. U.S. hysterectomy rates are much higher than in other Western nations; and rates vary by geographic region, ethnicity and socioeconomic status. Although alternative treatments are available, there is little data that compares these treatments to hysterectomy, or various types of hysterectomy to each other. This lack of information makes it more difficult for women to choose the best treatment option.

The following studies resulted from a "Request For Application" issued by AHCPR March 1. The total amount of the awards is $17.4 million over five years. The studies are: 

·  Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding. Principal Investigator Kay Dickersin, University of Maryland at Baltimore. Grant No. HS09506. 1996-2001.

The purpose of this study is to determine the equivalence of two therapies for DUB—hysterectomy and endometrial ablation—using two randomized controlled trials. The study will examine the natural history of DUB, the effectiveness of treatment and cost. 

·  MEDTEP Study on Hysterectomy and Dysfunctional Uterine Bleeding. Principal Investigator Sarah E. Fowler. Case-Western/Henry Ford Health Sciences Center, Detroit, Mich. Grant No. HS09502. 1996-2001. 

Using collaborative, multisite, randomized controlled trials, this study will compare the effectiveness, relative costs and patient outcomes of hysterectomy, endometrial ablation and hormone therapy for women with dysfunctional uterine bleeding.

·  Medicine Or Surgery? Principal Investigator Stephen B. Hulley, University of California at San Francisco. Grant No. HS09478. 1996-2001. 

The study will run two randomized controlled trials: one to compare the effects (including quality of life) and costs of medical therapy versus hysterectomy; the other to compare the effects of supracervical versus total hysterectomy on function and well-being in women who undergo abdominal hysterectomy. The study also will determine rates and patient preferences for management options for women with diagnoses of fibroids, dysfunctinal uterine bleeding, chronic pelvic pain, endometriosis or uterine prolapse.

For additional information contact, AHCPR PUBLIC AFFAIRS: Karen Carp, (301) 549-0313: Karen Migdail, (301) 594-6120; or Salina Prasas, (301) 549-6385.

Bev:This report is interesting when you take into consideration that in the Vick report of 1934 (See # 1.), "a major surgical procedure had one of the second highest incidence of causing adhesion formation, only second to multiple surgeries! "There is NOT ONE WORD about post surgical adhesive disease in this report!!


3.) Fact sheet:  Hysterectomy in the United States, 1980 - 1993

Frequency of Hysterectomy:

Approximately 600,000 hysterectomies are performed each year in the United States 
at an estimated annual cost of more than $5 billion.  More than one-fourth of  U.S. women will have this procedure by thetime they are 60 years of age. Hysterectomy is the second most frequent major surgical procedure among reproductive-aged women.

From 1980 through 1993, an estimated 8.6 million U.S. women had a hysterectomy.

Wanda K. Jones, Dr PH
Deputy Assistant Secretary for Health (Women’s Health)
 Director, Office on Women’s Health, U.S. Public Health Service

4.) Peritoneal Closure in Obstetric and Gynecological Surgery 1996 

Individual recommendations have been graded according to the level of evidence on which they are based using the scheme endorsed by the NHS Executive:

1. Background 
The traditional arguments for peritoneal closure have included, firstly, restoring the anatomy and approximation of tissues for healing, secondly, the re-establishment of a peritoneal barrier to reduce the risks of infection and, thirdly, a reduction in the risk of wound herniation or dehiscence. In addition, peritoneal closure was thought to minimize adhesion formation. 
On the other hand, there are arguments against peritoneal closure and these have been summarized by Duffy and diZerega.1,2Firstly, non-closure has not been observed to be detrimental, secondly, without re-approximation the peritoneum heals rapidly and, thirdly, suture presence and additional tissue handling may contribute to adhesion formation. There appears to be a good physiological explanation for this. Buckman et al3 showed that deperitonealised surfaces, which have not been otherwise traumatised, heal without permanent adhesions because they retain their ability to lyse fibrinous adhesions before organisation can occur. Peritoneum which has been made ischaemic by grafting or tight suturing not only loses its ability to lyse fibrin, but may actively inhibit fibrinolysis by normal tissues. 
2. Methodology 
A review of the literature was undertaken to establish the evidence for and against peritoneal closure in obstetric and gynaecological surgery. This included a 10 year MedLine literature search, and a reference search from review articles.4-6
3. Results 
3.1 Pathophysiological studies 
There is observational evidence that when left undisturbed, peritoneal defects demonstrate mesothelial integrity within 48 hours and indistinguishable healing with no scar formation in five days.3,7-11
3.2 Caesarean section RCTs 
The question of closure of peritoneum at caesarean section was addressed in four randomised controlled trials.12-15 In the last two studies, a reduced need for postoperative analgesia and a quicker return of bowel function was found when both visceral and parietal peritoneum14 or only the parietal peritoneum15 were left open. The most recent randomised controlled trial13 found shorter operating and anaesthesia times in patients receiving non-closure of the visceral peritoneum. In addition, the incidence of febrile morbidity and cystitis and the need for antibiotics and narcotics were all significantly greater when the peritoneum was closed.13 The hospital stay was significantly shorter after non-closure. Irion et al12 compared closure of both visceral and parietal peritoneum with non-closure. Postoperative ileus resolved later in the closure group and the mean operative time was shorter in the non-closure group. 
These four trials have all been included in the Cochrane Systematic Review.16 The review concludes that 'currently available evidence raises questions concerning the routine use of peritoneal closure as conventional practice in routine caesarean section' (Grade A recommendation). 
3.3 Gynaecological surgery RCTs 
Similar findings have been noted in randomised controlled trials carried out in gynaecology. Kadanali et al17 and Than et al,18 in ovarian cancer surgery and cervical cancer surgery respectively, found improved outcomes (reduced adhesions and reduced fever) where the visceral peritoneum was left to heal on its own. In general gynaecology, Lipscomb and co-workers19 found, in a randomised controlled trial of peritoneal closure at vaginal hysterectomy, that there were no differences in postoperative complications. Nagele et al20 in a randomised controlled trial of closure or non-closure of the visceral peritoneum in abdominal hysterectomy, found that the non-closure group had a smaller number of postoperative complications. 
It can be concluded that the data do not support the use of reperitonealisation on a routine basis
(Grade A recommendation). 
3.4 Other evidence (from observational studies and general surgical experience) 
Tulandi and co-workers11 did second-look operations in a series of patients who had parietal peritoneal closure compared to those without closure, and compared the findings to a control group of infertile women with no history of abdominal surgery. The incidence of adhesions in the two groups was not statistically significant with the incidence being 22.2% in the peritoneal closure group and 15.8% in the group not having peritoneal closure. In the control group of women who had never had abdominal surgery, no patients were found to have adhesions to the anterior abdominal wall. 
There have been a number of studies carried out in general surgery and the principle of non-closure of peritoneum has, for some time, been recognised by general surgeons. For example, Gilbert and co-workers21 showed that it was unnecessary to close the peritoneum with a paramedian incision. Hugh and co-workers22 found that single-layer closure of a midline abdominal incision (superficial part of the rectus sheath) was quicker and less costly and theoretically safer than layered closure, and they recommended that separate suture of the peritoneum be abandoned. 
In another surgical study23 the records of women who had been admitted with intestinal obstruction were examined. In this unselected patient series, a history of gynaecological surgery was a significant factor contributing to the occurrence of intestinal obstruction. They felt, in addition, that surgical peritoneal closure may result in an increased incidence of intestinal obstruction. 
4. Recommendations 
It would appear that the closure of peritoneal surfaces, even with minimally reactive suture materials, results in increased tissue reaction and may result in increased adhesion formation. Non-closure appears to have few associated risks and may be recommended in many obstetric and gynaecological operations. Surgeons abandoning closure should be no less meticulous in other aspects of their craft.

(Cont)
References 
1. Duffy D M, diZerega G S. Is peritoneal closure necessary? Obstet Gynecol Surv 1994; 49:817-22. 
2. diZerega G S, Duffy D M. Is peritoneal closure necessary? The Royal College of Obstetricians and Gynaecologists, 1996, PACE Review No 96/02. 
3. Buckman R F Jr, Buckman P D, Hufnagel H V, Gervin A S. A physiologic basis for the adhesion-free healing of deperitonealized surfaces. J Surg Res 1976; 21:67-76. 
4. Nygaard I E, Squatrito R C. Abdominal incisions from creation to closure. Obstet Gynecol Surv 1996; 51:429-36. 
5. Rayburn W F, Schwartz W J 3rd. Refinements in performing a cesarean delivery. Obstet Gynecol Surv 1996; 51:445-51. 
6. Hankins G D V, Clark S L, Cunningham G, Gilstrap L C (eds). Caesarean section. In: Operative Obstetrics, 1995. Appleton and Langer, Connecticut, 301-32. 
7. Elkins T E, Stovall T G, Warren J, Ling F W, Meyer N L. A histological evaluation of peritoneal injury and repair: implications for adhesion formation. Obstet Gynecol 1987; 70:225-8. 
8. Ellis H. The aetiology of post operative abdominal adhesions, an experimental study. Br J Surg 1962; 50:10 
9. Ellis H, Heddle R. Does the peritoneum need to be closed at laparotomy? Br J Surg 1977; 64:733-6 
10. McFadden P M, Peacock E E Jr. Preperitoneal abdominal wound repair: incidence of dehiscence. Am J Surg 1983; 145:213-4. 
11. Tulandi T, Hum H S, Gelfand M M. Closure of laparotomy incisions with or without peritoneal suturing and second-look laparoscopy. Am J Obstet Gynecol 1988; 158:536-7. 
12. Irion O, Luzuy F, Beguin F. Nonclosure of the visceral and parietal peritoneum at caesarean section: a randomised controlled trial. Br J Obstet Gynaecol 1996; 103:690-4. 
13. Nagele F, Karas H, Spitzer D, Staudach A, Karasegh S, Beck A, Husslein P. Closure or nonclosure of the visceral peritoneum at caesarean delivery. Am J Obstet Gynecol 1996; 174:1366-70. 
14. Hull D B, Varner M W. A randomized study of closure of the peritoneum at cesarean delivery. Obstet Gynecol 1991; 77:818-21. 
15. Pietrantoni M, Parsons M T, O'Brien W F, Collins E, Knuppel R A, Spellacy W N. Peritoneal closure or non-closure at cesarean. Obstet Gynecol 1991; 77:293-6. 
16. Wilkinson C S, Enkin M W. Peritoneal non-closure at Caesarean section. In: Neilson J P, Crowther C A, Hodnett E D, Hofmeyr G J (eds). Pregnancy and Childbirth Module of The Cochrane Database of Systematic Reviews, [updated 2 December 1997]. Available in The Cochrane Library [database on disk and CDROM]. The Cochrane Collaboration; Issue 1. Oxford: Update Software; 1998. Updated quarterly. 
17. Kadanali S, Erten O, Kucukozkan T. Pelvic and periaortic peritoneal closure or non-closure at lymphadenectomy in ovarium cancer: effects on morbidity and adhesion formation. Eur J Surg Oncol 1996; 22:282-5. 
18. Than G N, Arany A A, Schunk E, Vizer M, Krommer K F. Closure or non-closure of visceral peritoneums after abdominal hysterectomies and Wertheim-Meigs radical abdominal hysterectomies. Acta Chir Hung 1994; 34:79-86. 
19. Lipscomb G H, Ling F W, Stovall T G, Summitt R L Jr. Peritoneal closure at vaginal hysterectomy: a reassessment. Obstet Gynecol 1996; 87:40-3. 
20. Nagele F, Kurz C, Staudach A, Steiner H, Grunberger W, Beck A, Husslein P. Closure or nonclosure of the visceral peritoneum in abdominal hysterectomy. J Gynecol Surg 1995; 11:133-9. 
21. Gilbert J M, Ellis H, Foweraker S. Peritoneal closure after lateral paramedian incision. Br J Surg 1987; 74:113-5. 
22. Hugh T B, Nankivell C, Meagher A P, Li B. Is closure of the peritoneal layer necessary in the repair of midline surgical abdominal wounds? World J Surg 1990; 14:231-3. 
23. Stricker B, Blanco J, Fox H E. The gynecologic contribution to intestinal obstruction in females. J Am Coll Surg 1994; 178:617-20. 
24. Mann T. Clinical guidelines: using clinical guidelines to improve patient care within the NHS, 1996. NHS Executive (Catalogue No 96CC0001).


5.) Scars and Adhesions

Adhesions have been implicated as causing infertility, intestinal obstruction, and chronic pelvic pain.  Data suggests that 67% to 93% of patients will develop adhesions following abdominal surgery and 55% to 100% of patients will develop adhesions following gynecologic surgery.3

1998 © Clear Passage Therapies, Inc.


6.) December 2000 American Journal of Obstetrics & Gynecology 183, pp. 1440-1447. 

Hospital readmission due to complications after hospital discharge was the factor most strongly and consistently associated with women's reports of negative outcomes from hysterectomy.  For example, women who were readmitted to the hospital during the first year after hysterectomy were 23 times more likely to report that the results of the surgery were worse than they had expected, after adjustment for all other factors.  About 5.4 percent of women were readmitted at least once to the hospital during the 2 years of follow up, and 4 percent were readmitted during the first year.  The most common reasons for readmission were incision problems, surgery for adhesions, intestinal blockage, and urinary tract problems.

For more information, see "Patient satisfaction with results of hysterectomy," by Kristen H. Kjerulff, Ph.D., Julia C. Rhodes, Ph.D., Patricia W. Langenberg, Ph.D., and Lynn A. Harvey, in the December 2000 American Journal of Obstetrics & Gynecology 183, pp. 1440-1447.


7.) From:  Southern Medical Journal  (2001)

Chronic Intermittent Intestinal Obstruction From a Seat Belt Injury

Janet R. Harrison, MD, Michael O. Blackstone, MD, Thomas Vargish, MD, Arunas Gasparaitis, MD, Division of Gastroenterology, University of Chicago Hospitals, Chicago, Ill 

Abstract

Most patients with intestinal obstruction have had previous surgery.  Rarely, the development of adhesions and resulting small bowel obstruction is attributed to previous intra-abdominal trauma. We present the case of a young man, without a history of surgery, who had been a restrained driver in a motor vehicle crash. Seven years later, the patient had an intermittent partial small bowel obstruction that recurred over the next 5 years. We review the pathophysiology and epidemiology of similar occurrences, as well as diagnostic options.

[South Med J 94(5):499-501, 2001. © 2001 Southern Medical Association] 


8.) Internationa Adhesions Society:  The Magnitude of the Problem of Adhesions

The rate of adhesion formation after surgery is surprising given the relative lack of knowledge about adhesions among doctors and patients alike.  From autopsies on victims of traffic accidents, Weibel and Majno (1973) found that 67% of patients who had undergone surgery had adhesions.  This number increased to 81% and 93% for patients with major and multiple procedures, respectively.  Similarly, Menzies and Ellis (1990) found that 93% of patients who had undergone at least one previous abdominal operation had adhesions, compared with only 10.4% of patients who had never had a previous abdominal operation.  Furthermore, 1% of all laparotomies developed obstruction due to adhesions within one year of surgery with 3% leading to obstruction at some time after surgery. Of all cases of small bowel obstruction, 60-70% of cases involve adhesions (Ellis, 1997). 
Lastly, following surgical treatment of adhesions causing intestinal obstruction, obstruction due to adhesion reformation occurred in 11 to 21% of cases (Menzies, 1993).
Between 55 and 100% of patients undergoing pelvic reconstructive surgery will form adhesions.

The impact of adhesions as a complication of surgery is huge.  In the United States (1993) 347,000 operations for lysis of peritoneal adhesions were performed (Graves, 1995), of which about 100,000 involved intestinal adhesions.  Estimated another way, 446,000 procedures were performed in the U.S. to lyse abdominopelvic adhesions in 1993 (HCIA, 1994).
In 1988, there were about 280,000 hospitalizations for adhesions, the economic cost of which was estimated conservatively as $1.2 billion per year (Fox Ray et al., 1993)


9.) Incidence of Pelvic Adhesions

The incidence of pelvic adhesions varies following reconstructive surgery.  Diamond et al noted an 86% incidence of pelvic adhesions at second-look laparoscopy after reconstructive surgery.  DeCherney and Mezer abserved a 75% incidence of adhesions after the initial procedures at 4-16 weeks.

Surrey and Friedman noted a 71% incidence of adhesion formation.  When a subset of these patients were studied long-term, 83% of them had adhesions.  Pittaway et al found that all 23 of their patients had adhesions.  Trimbos-Kemper et al observed adhesions in 55% of their patients.  Finally, Daniell and Pittaway noted adhesion formation in 96% of women at second look laparoscopy following reconstructive surgery.

It is important to note that the adhesions seen in these studies represent not only adhesion reformation, but De Novo adhesion formation as well.

[Bev: De Nova adhesions are reformed adhesions.]

Reference:
Diamond MP. Surgical aspects of infertility. In: Sciarra JW, ed. Gynecology and Obstetrics. Philadelphia, Pa: Harper & Row; 1988;5:chap 61.


10.) Making and covering of surgical footprints (surgical adhesions). (Commentary)
Author/s: Lena Holmdahl
Issue: May 1, 1999

There is little doubt that abdominal adhesions form in response to peritoneal trauma. Although adhesions may result from events occurring during fetal development, the vast majority can be directly linked to surgery. However, adhesions have not been widely held to be a surgical complication, even though the impact of just one complication due to adhesions -- that of small-bowel obstruction after colorectal surgery -- equals, or surpasses, that of wound infection.1,2
(In part, full report on request)


BEV: The ICD9-CM code IS primarily for the use of adhesion barriers in a surgery and I agree that is vital, if we are going to impact ARD in a progressive way and offer opportunities that will help to benefit some adhesion sufferer and put them on the road to a higher quality of life!

I see more possibilities for this ICD9-CM, as well. Once this ICD9-CM code is approved, the doors will be open once again for the U.S. Government to take a look at the impact that Adhesion Related Disorder has on our society!! The acceptance of this code will give those government officials (whom I mentioned earlier) - who have the responsibility to make changes in our national health care system - the opportunity to right a wrong!!  Hopefully, these officials will be compassionate, honest people with new and progressive attitudes about the welfare of their consitituents!!

There is no doubt in my mind that this ICD9-CM code will be secured;  because it would be plain negligence for any national government agency to ignore or deny that there is overwhelming evidence that post surgical and traumatic adhesions are one of the most costly medical expenses in the United States today!!!

Our government is experiencing a new generation of voters and tax payers, who are better educated and better informed than ever before; because ready access to information does not allow anything to be hidden from anyone who looks for it today!

The word is already out regarding Adhesion Related Disorder;  and the facts surrounding ARD will not disappear!! Governmental agencies and positions will be held accountable for the health care needs of our nation's taxpayers. Attention to those needs must start now with the implementation of this new ICD9-CM code for the application of adhesion barriers for adhesion protection!! If it is not, someone will have to answer to why it wasn't implemented!!

If the governing bodies of our nation's health care system had heeded reports - like those I have share with you (reports numbered 1-10) - those who currently suffer from Adhesion Related Disorder might have been spared the pain and anguish so many experience today!!  Reports show that our tax dollars have been spent on government-funded health care programs; and these reports prove - without a doubt - that post surgical adhesions have impacted the people of our nation with unnecessary suffering at a staggering rate and cost!!

Questions are beginning to surface as to why has there never been a national campaign for awareness and education about the existence and etiology of post surgical adhesions?  Our government knew of the magnitude of this medical problem!!  How come the numbers increased instead of decreased?  There are hundreds of thousands of people in this country, who struggle with the intractable pain of adhesions on a daily basis - every minute of each day!! Had the government responded to these reports in a responsible and respectful way, these people could've had a better chance for a more comfortable, pain-free life.

If only I had known that adhesions are one of the risks of surgery, I know that I could be enjoying a higher quality of life today; and there is no doubt about that at all! 

If our government health agencies had acted in our best interests when the connection between surgery and adhesions first became known, many people of this great nation could have been spared alot of pain and suffering; and the resulting tremendous cost to our government could have been averted!!

We trusted our government to inform us about health issues;  but our government failed us when we were not given the opportunity to be informed so that we would be able to make informed decisions about our personal health issues.

I am asking the Centers for Medicare and Medicaid Services to pursue with diligence in getting the ICD9-CM surgical code approved for the application of adhesion barriers for adhesion protection.  I am offering my assistance in any way possible.

This code is justified; and God knows it is time to get it secured for the United States of America! 

In peace and friendship,
Beverly J. Doucette

cc: 
Dr. David Satcher, MD, Surgeon General
Tommy Thompson, Secretary of the U.S. Department of Health and Human Services
Mr. John Gard, Assemblyman, Wisconsin 89th Assembly District 
Dr. David Wiseman, PhD, SYNECHION, INC.
Dr. Frank Hamilton, M.D. M.P.H. Chief, NIDDK Division of Digestive Disease And Nutrition - Dept. of Health & Human Service
Lynn Armstrong, National Centers for Disease Control and Prevention (CDC) Atlanta, GA


Letter from Dr. Frank A. Hamilton acknowledging my communication to Secretary Tommy Thompson May 4, 2002
 


 
 

Bev's response to Dr. Frank A. Hamilton  May 18, 2001

May 18, 2001

Beverly J. Doucette
Patient Advocate
Adhesion Related Disease
Marientte, Wisconsin 514431

Dr. Frank A. Hamilton, M.D., M.P.H.
Chief, Digestive Diseases Program,
NIDDK Division of Digestive Disease 
And Nutrition
Dept. of health & Human Service
2 Democracy Plaza
Room 669, 
Bethesda, MD, 20892
phone: (301) 594-8877
email: hamiltonf@ep.niddk.nih.gov
 

Subject: Re: Adhesion Related Disease

Dear Dr. Hamilton;

I am Beverly J. Doucette, Patient Advocate for persons suffering Adhesion Related Disease. I am a volunteer with the International Adhesion Society and the director of the IAS outreach program as well as being instrumental in many other areas of the IAS.

Dr. Hamilton, you were directed to respond to my communication to Secretary Tommy
 Thompson regarding ARD and I thank you for taking the time to do that.
If you recall, you enclosed a number of pages containing information on ARD research as well. You also closed your letter by saying that you hoped this information would be helpful to me.

I was pleased to receive your directive’s to help me explore the avenues to possible secure assistance in educating the public about adhesion related disease.  Your referral to John D. Chapin, Administrator of the Wisconsin Dept. of Health and Family Services in Madison is greatly appreciated. I did follow up on your advice to check into the Centers for Disease and Prevention (CDC) of Atlanta, GA. Unfortunately there was no mention of adhesions anywhere within the contents of this web site. I did make inquires as to that and will continue to pursue the reasons why ARD is not a part of this centers interests.
 

The unfortunately thing, Dr. Hamilton, was that non of your information regarding “Research of Adhesion Tissue & Studies ” was news to me and all of it simply substantiated what I was aware of in the first place...there is NO current effective research being conducted anywhere in the world, that we are aware of, that will impact the lives of those suffering ARD today, nor will it affect those currently suffering the most painful and disabling complications of ARD in the near future!

 I was somewhat amused at the growing number of adhesion tissue researchers I have now amassed, your additions included!!! It appears that one out of every ten scientist in the world is looking to win the  “Pulitzer” prize by figuring out adhesion formation!  With the progress that has been made in this area of research within the past 15 years, not with standing the measly amounts of grant money given to this, I fear we shall not see anything resolved on adhesion tissue in our lifetime, short of a miracle that is!

In fact, Dr. Hamilton, I think that the information I attached in this email to you will offer you much more education regarding Adhesion Related Disease then your information did for me!    My information is current at that!  You did state that Dr. James Pachence at Vertitas Medical Technologies, Inc. had recently completed the study you sent me, but no dates were given on that study as to just how recent they were.

I also went to the web site of the Center for Disease Control and Prevention (CDC) and based on what I did NOT find in that site simply substantiated what I had known. "Adhesion Related Disease" is one of the worlds best kept medical secrets! That will not continue to be the case as the IAS, under my direction, is currently completing the 
"ARD Press Kit " and we have a number of reporters throughout the USA waiting to receive them.

I am not sure what you thought you were going to accomplish in sending me
the research information that you did, or if you simply thought I was not
acclimated to ARD to the degree that I am.  I am inclined to think the later is true.

Dr. Hamilton, I know Dr. Lena Holmdahl of Sweden personally, and I am
very familiar with her research on adhesions, her philosophy's on ARD and her
choice of adhesiolysis procedures! If you are interested in those issues, feel
 free to ask me about them.  I am also very familiar with the three Dr.'s Nezhat, and I am very acclimated to their ARD research and claims. I have attached the most current information I have received regarding the Dr.s Nezhat encompassing those very same issues! For the record, Dr. Hamilton, I have been following a number of the issues surrounding these Dr.s for two years now.

You might be interested to know that in April of 2000 and again this week, I was approached by the Lifecore / Ethicon Pharmaceutical Division of Johnson & Johnson to speak on their behalf in front of the FDA regarding the adhesion barrier, " Intergel!"  I am not going to accept that offer though.

 I am also very acclimated to the clinical trials of this product, both herein the United States as well as in Europe. I was able to study the use of and effectiveness of Intergel on my two trips to Europe last year by the way.

Dr. Hamilton, my intentions for submitting the information of Adhesion Related Disease to Secretary Thompson was to impress upon him a number of issues surrounding ARD. The IAS intends to focus attention on a number of issues concerning ARD through the news media by use of our press kits. I did not want Tommy Thompson to be blindsided by the press and the public in general once this information gets published.

Among the issues we intend to address are:
 * Promote awareness of Adhesion Related Disease
 * Provide information on ARD, it's treatments and prevention
 * Provide information on the impact of ARD on society
 * The lack of research regarding ARD
 * The lack of medical intervention for those who suffer ARD
 * Including the lack of medical insurance coverage and
 * And securing disability benefits for ARD sufferers among other things.

The IAS has also been invited to personally present our issues on ARD to the Surgeon General, Dr. David Satcher M.D. as well as the Honorable Judy Biggert, Member of Congress, and co - chair person for the "Women's Caucus. "

Dr. Hamilton, I am considered by some to be the most informed consumer of
Adhesion Related Disease in the world today, therefore, I am not easily
satisfied with most of the communications I receive from persons within the
medical community regarding ARD!  Over all the information you sent to me
was of no benefit to me other then to support my own findings on ARD in that there is very little being done to educate the public and health providers in the United States!

I do have one question for you that I am hoping you will elect to answer for me:
Based on the high incidence of ARD in our society, the extremely high percent of people impacted by ARD in so many disabling ways and the massive financial burden ARD places on America today, why is it that your office, the CDC and many other public institutions, that are being paid for by U.S. tax payers money, have not focused ANY public awareness on ARD or attempted to reach out in a positive and progressive way to help those who suffer it?

Dr. Hamilton, this same information is pointed out in a number of the research papers you sent to me, and you knowing that there is no plausible medical intervention for ARD  sufferers at this time, there is still no action taken to educate the public on it? Seems strange to me! I ask you to please
 

Dr. Hamilton, you will note the information that I have regarding the studies you sent for my review: 

Lawsuit against Doctors” which involves two of the Nezhat surgeons. 
I submit this report in response to the research paper you sent to me stating:

 “Laporoscopic adhesiolysis and relief of chronic pelvic pain” 
 Nezhat FR, Crystal RA, Nezhat CH, Neahat CR

I believe you can see why a report such as the one you sent to me cannot be regarded by me to be worth anything! I also have followed a number of the Nezhat surgeon’s adhesion patients, and to date, I would have to say those surgeons are quite fortunate they are only involved in one lawsuit!

  I have enclosed some of MY research information for Your review, (in part only!)

 “Hocking, D.C., J. Sottile, et al. (2000) “Stimulation of Intergrin-mediated Cell
is 48 pages in total.

Cell Adhesion and Cell Adhesion Molecules” is 38 pages in total.

The Lancelot” is one page total.

Antibody solution may prevent adhesions after surgery” is 16 pages total.

I thank-you for taking the time to consider this email and if there is
anything more I can offer you on the subject of Adhesion Related Disease, please do not hesitate to call on me.

In peace and friendship,
Beverly J. Doucette
http://www.pathwaystohope.org
http://www.adhesions.org/Links/
http://www.adlap.com
 
 

Harry Truman said, "I didn't really give ‘em hell. I just told the truth and it felt like hell."

Cc:  Secretary T. Thompson   U.S.A.  Dept. of HSS
       Dr. Haile T. Debas   Dean of UCSF 
       Dr. James M. Pachence  Veritas Technologies
       John D. Chapin   Director of the WI Dept. of HSS
       Dr. David Satcher M.D.  U.S.A. General Surgeon 



All the following are attachments to the May 18, 2001 letter to Dr Hamilton.

Beverly J. Doucette
Patient Advocate
Adhesion Related Disease
Marientte, Wisconsin 514431

The enclosed research information is in part only!
 “Hocking, D.C., J. Sottile, et al. (2000) “Stimulation of Intergrin-mediated Cell… is 48 pages in total.

“Cell Adhesion and Cell Adhesion Molecules” is 38 pages in total.

“The Lancelot” is one page total.

“Antibody solution may prevent adhesions after surgery” is 16 pages total.

Dr. Hamilton, you will note the information regarding the:
“Lawsuit against Doctors” which involves two of the Nezhat surgeons. 
I submit this report in response to the research paper you sent to me stating:
 “Laporoscopic adhesiolysis and relief of chronic pelvic pain” 
 Nezhat FR, Crystal RA, Nezhat CH, Neahat CR

I believe you can see why a report such as the one you sent to me cannot be regarded by me to be worth anything! I also have followed a number of the Nezhat surgeons adhesion patients, and to date, I would have to say those surgeons are quite fortunate they are only involved in one lawsuit!

In peace and friendship,
Beverly J. Doucette
http://www.pathwaystohope.org
http://www.adhesions.org/Links/
http://www.adlap.com

Harry Truman said, "I didn't really give ‘em hell.  I just told the truth and it felt like hell."

Cc: Secretary T. Thompson   U.S.A.  Dept. of HSS
       Dr. David Satcher M.D.  U.S.A. General Surgeon 

2.) The following attachments reflect the issues brought forth by Dr. Frank A. Hamilton National Institue of Health, in his letter dated May 4, 2002:
 
"Laparoscopic adhesiolysis and relief of chronic pelvic pain."

"Longstanding Malpractice Suit Involving Nezhat Brothers, 'Pioneers' in Endometriosis Surgery, Quietly Resolved

"Nezhat Lawsuit Daily Reproductive Health Report

Daily Reproductive Health Report

In The Courts | Longstanding Malpractice Suit Involving Nezhat Brothers, 'Pioneers' in Endometriosis Surgery, Quietly Resolved
[Jun 07, 2002] 

      A nine-year Georgia malpractice suit that "embroiled the world of American gynecology in searing debate" has come to an end, although neither side is willing to disclose how the dispute was resolved, the Philadelphia Inquirer reports (Lubrano, Philadelphia Inquirer, 6/6). The suit was brought against the Stanford University gynecologic surgeons Camran and Farr Nezhat, two brothers who were once considered "pioneers" in the field of endometriosis surgery, by Stacey Mullen, a patient who accused the brothers of "grievously injur[ing]" her during an operation for endometriosis in 1991 (Russell, San Francisco Chronicle, 6/5). Mullen had alleged that the Nezhats performed a "risky experimental procedure without her consent" that left her incontinent and "vomiting feces" for years (Ostrov, San Jose Mercury News, 6/4). The procedure, called a "rectal pull-through," involves severing the blood and nerve supply to a patient's rectum so that it can be operated on outside of the body. Numerous surgeons have since denounced the procedure as "barbaric" (Philadelphia Inquirer, 6/6). According to a docket entry in Fulton County Superior Court, Mullen withdrew her lawsuit on May 24, 2002. Court records of the case remain sealed, and Mullen's attorney, Robin Loeb, "would confirm only that 'the case has been resolved'" (San Francisco Chronicle, 6/5). Neither the Nezhats -- who have "consistently denied wrongdoing" -- nor their attorney returned calls to the San Jose Mercury News.

A Professional Fall from Grace 
The Nezhats came to Stanford from Georgia in 1993, "having been hailed for their innovations in the field of gynecologic surgery and the treatment of endometriosis" (San Jose Mercury News, 6/4). The two brothers were featured on ABC's "Good Morning America" and "20/20," and they were the focus of "glowing" stories in Time and Newsweek (Philadelphia Inquirer, 6/6). However, shortly after their arrival in California, two Stanford colleagues accused the Nezhats of "performing needless operations and covering up" surgical complications, and several newspaper stories reported that the brothers "withh[eld] serious complications of new surgical techniques in published journal articles." The journal Surgical Laparoscopy, Endoscopy and Percutaneous Techniqueslater renounced two articles about the rectal pull-through that were written by the Nezhats. Stanford University eventually revoked the brothers' medical school teaching privileges, as well as a third brother, Ceana Nezhat, and removed them from the directorship of the Stanford Endoscopy Center for Training and Technology (San Francisco Chronicle, 6/5). Throughout the controversy, the Nezhats insisted that the accusations against them were "groundless" and "rooted in professional jealousy." Several legal experts speculated that the malpractice case was resolved in a financial settlement in which the brothers paid damages to Mullen. According to Stephen Burbank, a law professor at
the University of Pennsylvania, the "confidential" nature of the resolution suggests that "one of the parties is anxious not to have the terms of the settlement known" (Philadelphia Inquirer, 6/6).
 

3.) The following attachments reflect issues brought forth by me in response to the communication from Dr. Frank A. Hamilton!
The "Three Stooges" Nezhats

The article details a series of rectal surgeries performed on 16 
women in 1991 and 1992, by the researchers,
Drs. Farr and Camran Nezhat.


THE NEW information came to light in a lawsuit against the doctors by a woman who said she was injured by the surgery described in the journal article. The article details a series of rectal surgeries performed on 16 women in 1991 and 1992.

In two affidavits unsealed Wednesday in Atlanta by the judge in the case, expert witnesses for the plaintiff, Stacey Mullen, said the results and the details of the surgeries reported in the paper differ widely from the original patient records.

The researchers, Drs. Farr and Camran Nezhat, who run surgical centers in Atlanta and at Stanford University in California, failed to report several serious complications that occurred as a result of the surgeries, according to the affidavits. The original patient records also show that the actual length of time it took to perform the surgeries was far longer than what the Nezhats reported in the paper, according to court documents. The Nezhats wrote that the surgeries averaged a little over three hours. But the documents show they averaged about six hours, with one operation lasting as long as 10 hours.

Similarly, the amount of blood each patient lost during the procedures was significantly greater than what the Nezhats wrote, according to the affidavits. One patient lost six times the maximum reported by the researchers, according to the affidavits.

“Not one single patient listed in the . . . article matches the medical records exactly,” wrote plaintiff experts Dr. Nick Spirtos, deputy chief of the department of gynecology and obstetrics at Stanford University Hospital, and Dr. Tom Margolis, former chief of the division of gynecology at Stanford University, now in private practice. 

Health Library: Women's Health

Nezhat attorneys vehemently denied the allegations. “The affidavits are misleading,” said David Walbert, an Atlanta attorney. “They are totally false from A to Z.”

Walbert said that there were no complications associated with the Nezhat surgeries. He added that, “these women have had years of surgical experiences with other doctors and they have very bad disease, and that has nothing to do with the Nezhats.”

The longer operative times and blood losses noted in the affidavits were simply the result of patients having multiple procedures, Walbert said. Others disagreed. “For someone having surgery for endometriosis, which is a benign disease, a blood loss [like the patient had] is completely unacceptable,” said Dr. Morris Wortman, a clinical associate professor of gynecology and obstetrics at the University of Rochester and director of the Center for Menstrual Disorders and Reproductive Choice, both in Rochester, N.Y.

It increases the likelihood that a person will need a transfusion, said Dr. Barbara Levy, a clinical assistant professor of obstetrics and gynecology at the University of Washington in Seattle and at Yale University in New Haven, Conn., and a former president of the American Association of Gynecologic Laparoscopists. 

“And that, in turn, increases the risk of hepatitis and other blood-borne diseases,” she added. “There is also the risk of a transfusion reaction. If a lot of blood is lost, but not enough to necessitate a transfusion, it can still diminish the body’s oxygen carrying capacity. Then patients don’t heal as fast and they have a higher risk of infection.

Regarding surgical times, both Wortman and Levy said the longer a patient is under anesthesia, the greater the risk. “Ten hours is a frightfully long time to be under anesthesia,” Wortman said.  “Operating times of this magnitude would only be seen in cancer surgery where you’d be justified in putting a patient at that kind of risk. Anesthesia alone is a risk.”

Levy agreed. “There is a risk of heart suppression with the anesthetic, of hypothermia,” she said. “The longer you fool around in there there is a greater risk of damaging organs.”

Further, Walbert said that any criticisms by Spirtos and Margolis would be unfair because they are competitors of the Nezhats.

Still, the records of the 16 patients have also been the subject of a seven-year Georgia Medical Board investigation. And a source close to the investigation confirmed the content of the affidavits.

“There is little correlation between these 16 cases and those listed in the paper,” the source said. “There were complications that were not reported, including an ileostomy [an operation in which the contents of the intestine are emptied through a hole in the abdomen into a bag, rather than through the rectum] and massive rectal bleeding.” And, the source added, “The operative times were much longer than reported.”

In 1992, the operation described in the paper was lauded by Ethicon Endosurgery, a subsidiary of Johnson & Johnson, as a “revolutionary” procedure that could provide relief for the 185,000 women who suffer from rectal endometriosis. Ethicon is the maker of instruments used by the Nezhats in the surgery, according to court records.

Physicians and medical ethicists said they were greatly disturbed by the possible discrepancy between the actual data and the paper, which was published in Surgical Laparoscopy & Endoscopy in 1992.

“This kind of [discrepancy] would be the hallmark of negligence in reporting,” Wortman said. “It would be more than irresponsible. It would rise to such a level of lying and cheating and misrepresenting information that people who read these things to help patients would be seriously led astray and misguided by the information. It would be an attempt to defraud other physicians.”

Medical ethicist Arthur Caplan said this kind of alleged misreporting is dangerous.

“It puts not only the [surgical] subjects’ lives at risk, but risks the health and welfare of others because doctors rely on information like this for treatment,” said Caplan, the director of the Center for Bioethics at the University of Pennsylvania in Philadelphia. “It really puts a lot of people in jeopardy.”

A government expert in research fraud said that this kind of alleged misrepresentation would be uncommon. “I’m not aware of any case comparable to this with this kind of alleged fabrication regarding a surgical procedure,” said Chris Pascal, acting director of the Office of Research Integrity at the Department of Health and Human Services. 

Mullen is suing the Nezhats because she claims that they performed an unnecessary, experimental surgery on her without her permission that resulted in injuries to her bowel, including fecal incontinence and loss of the use of her rectum. Today she must evacuate waste through a 14-inch tube that drains an always-open-hole in her abdomen.

According to the affidavits, Mullen wasn’t the only patient to suffer incontinence after her surgery. “Patients reported significant bowel dysfunction with anal incontinence of various degrees of seriousness, none of which are mentioned” in the article, Margolis wrote.

In the past, other researchers have questioned Nezhat data. 

For example, after a Nezhat article was published describing 4,000 surgeries without a single ureter injury — an unheard of feat — three Yale University professors replied in a letter to Obstetrics and Gynecology in 1990:  “Either these surgeons had other complications perhaps as serious or they possess an unbelievably high level of skill and judgment.”

Levy, a journal editor, said the case highlights a weakness in the review process for medical journals. If the affidavits are true, “this would be fraud,” she said. “If this is true, it’s unfortunate that it’s been published and that doctors have used it to make decisions for women for surgery. It shows a fundamental flaw in our peer-review system. We don’t go back to analyze raw data.  We have to make the assumption that the authors are giving us the appropriate information.

“In a case like this, what we would do is write a letter to the doctor and tell him he was not eligible to publish in our journal [The Journal of the American Association of Gynecologic Laparoscopists] any more.”

Stimulation of Intergrin-mediated Cell…2000 Apr 7
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=10744764

Cell Adhesion and Cell Adhesion Molecules http://www.csa.com/csa/e_products/bacontent/BSS000392.html

Antibody solution may prevent adhesions after surgery. September 27,1999
http://www.unc.edu/news/archives/sep99/lessey092799.htm

The Lancelot: http://clos.net/complications/adhesions2.htm

The Lancet (1999;353:1456-1457).

Rate of Adhesion-Related Complications High

The rate of complications associated with adhesions following abdominal and pelvic surgery is high, according to a retrospective cohort study published in The Lancet (1999;353:1456-1457).

The leader of the study, Dr. Harold Ellis, described the readmissions for adhesion-related complications as a substantial burden" having "important consequences to patients, surgeons and the health system." Dr. Ellis is a professor in the Division of Anatomy, Cell and Human Biology at The Guy's, King's and St. Thomas' School of Biomedical Sciences, London.

The team used data from the Scottish National Health Service medical record database to identify patients undergoing open abdominal or pelvic surgery in 1986. Altogether, 21,374 readmissions for adhesion-related complications were recorded during 10-year follow-up.

Of the readmissions, 1,209 (5.7%) were directly related to adhesions. Surgery was performed to address the adhesions in 768 readmissions (3.6%). However, the researchers suggest that because of the design of their study, these figures most likely underestimate the actual number of readmissions for adhesions.

According to Dr. Ellis and his team, .overall, 34.6 percent of the 29,790 patients who underwent open abdominal or pelvic surgery in 1986 were readmitted a mean of 2.1 times over 10 years for a disorder directly or possibly related to adhesions, or for abdominal or pelvic surgery that could be potentially complicated by adhesions."

The study authors stressed the importance of identifying high-risk procedures associated with adhesion complications and the need to develop effective prevention strategies.

In a commentary following the study, Dr. Lena Holmdahl, associate professor of medicine at Gothenburg University, in Sweden, referred to the group's work as a "cornerstone in delineating the problem" of adhesion-related complications. "Perhaps this study will stimulate industry, administrators and surgeons alike to acknowledge the size of the problem posed by adhesions and to act,"Dr. Holmdahl wrote.

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The rate of complications associated with adhesions following abdominal and pelvic surgery is high,
according to a retrospective cohort study published in The Lancet (1999;353:1456-1457).

4.) Other works by Dr. Lena Holmdahl Sahlgrenska University Hospital/Östra, Göteborg University,
Göteborg
The Lancet " Surgical Footprints  by Dr. Lena Holmdahl 

The Lancet Interactive

Making and covering of surgical footprints.(surgical adhesions)(Commentary) 
Author/s: Lena Holmdahl
Issue: May 1, 1999

There is little doubt that abdominal adhesions form in response to peritoneal trauma. Although adhesions may result from events occurring during fetal development, the vast majority can be directly linked to surgery. However, adhesions have not been widely held to be a surgical complication, even though the impact of just one complication due to adhesions -- that of small-bowel obstruction after colorectal surgery - - equals, or surpasses, that of wound infection.1,2

Why is there this discrepancy between impact and acknowledgment of this complication? The answer is simple: the formation of intra-abdominal adhesions cannot be assessed unless the abdomen is reopened. Even then, adhesions are difficult to quantify. For years, in the treatment of female infertility, gynaecologists have dealt with the consequences of adhesions. The ineffectiveness of adhesiolysis in improving fertility propelled the development of in-vitro fertilisation. In surgery, however, the dominant complication due to adhesions (small-bowel obstruction) may not manifest until many years after the operation. Up to a fifth of first episodes of this complication occur two decades after the triggering procedure.3 Although clinically recognised to be a major problem, the lack of non-invasive means of quantifying adhesion formation, combined with the many years needed before a clincial trial yields results, have deterred research in this area. Adhesions have thus come to be perceived as an inevitable consequence of surgery, about which little can be done.

Although adhesions are far from completely investigated at the cellular and molecular level, a central pathophysiological mechanism leading to their development has emerged from animal studies.4-7 When the peritoneum is injured, bleeding and leakage of plasma proteins from damaged surfaces form a fibrinous deposit in the abdominal cavity (figure). This process is further fuelled by the subsequent post- traumatic inflammation. Fibrin, the function of which is restoration of injured tissues, is sticky, so the fibrinous exudate may attach to adjacent intra-abdominal structures. During the first few days after injury, this attachment seems to be reversible and the exudate undergoes enzymatic degradation by locally released fibrinolytic factors. As a part of the wound-healing response, fibrin deposition triggers a tissue-repair process that extends into the fibrin scaffolding. Within 5 days, the fibrin mesh is invaded by proliferating fibroblasts, which replace the fibrin with more durable components of the extracellular matrix (ie, collagen). Once this event has occurred, the adhesion is believed to be irreversible. Thus, the balance between fibrin deposition and degradation during the first few days is critical to the development of adhesions.

The pathogenesis of adhesions is difficult to study in human beings. The peritoneal cavity is inaccessible postoperatively, which restricts investigations of postoperative events. In recent years, investigations have been done intraoperatively. Such studies have shown a reduced peritoneal fibrinolytic capacity in conditions associated with the development of adhesion (peritonitis and surgery).8,9 Trauma has been reported to rapidly lower the main fibrinolytic stimulator, tissue-type plasminogen activator (t-PA),10 and subsequently to increase its inhibitor, plasminogen activator inhibitor type-1 (PAI-1).11 Patients with extensive adhesions were reported to have an overexpression of PAI-1 in peritoneum.12 Although there is no direct evidence of a causal relation between impaired fibrinolysis and formation of adhesions in human beings, the accumulated data strongly support the notion that a compromised peritoneal fibrin-clearing capacity favours the development of adhesions, and is in keeping with the current concept of the pathophysiology.

There is no treatment for adhesions other than surgery. Most patients who have undergone abdominopelvic surgery develop adhesions, but the vast majority are symptom-free. Because surgically divided adhesions are extremely likely to form again, with recurrence of symptoms,13 adhesions should not be treated unless clinically prompted. Prevention of adhesions is thus of the utmost importance.

From the proposed mechanisms by which adhesions develop, several approaches to adjuvant therapy emerge -- reduction of fibrin deposits by limitation of the inflammatory response; facilitation of the degradation of fibrin with fibrinolytic stimulators; and separation of surfaces during the time fibrin remains sticky. Results from animal experiments clearly show that all these approaches are effective. However, the possible side-effects of modulating the inflammatory response (infection, delayed wound healing) and administering fibrinolytic stimulators (bleeding) have made separation of tissue surfaces the most attractive option. Tissues can be physically separated during the critical period postoperatively by application of a bioresorbable membrane or film at injured sites, which presumably prevents the formation of fibrin bridges and thus of adhesions. Clinical trials with barriers based on hyaluronic acid have shown reductions in quantity of adhesions of up to about 50% in abdominal14 and pelvic surgery.15 Other barrier formulations are being tested.

Why barriers have not proven 100% effective is not clear. Biological variability12 may be part of the explanation, but other factors may also be important. Because adhesions result from peritoneal trauma and inflammation, events occurring during surgery are obvious candidate factors. There is general agreement that surgical procedures and materials used should be "atraumatic". However, this oxymoron does not provide any guidelines as to what constitutes an atraumatic injury. It is therefore not surprising, albeit noteworthy, that surgical techniques, materials, devices, and other accessories used during the operation are not commonly tested for their potential to influence peritoneal tissue repair and adhesion formation. Laparoscopic surgery is commonly assumed, but has not been proven, to eliminate the problem with adhesions. In fact, reports have been conflicting, so measures for reducing the formation of adhesions will be needed with laparoscopic surgery.

Because of the difficulties in the assessment of the clinical consequences and size of adhesion-related complications, the epidemiological study in today's Lancet by Harold Ellis and co-workers is a cornerstone in delineating the problem. Perhaps this study will stimulate industry, administrators, and surgeons alike to acknowledge the size of the problem posed by adhesions and to act. Although the best option is prevention by use of a barrier based on hyaluronic acid, the ultimate question is whether reduction of adhesion formation translates into fewer clinical complications. This issue is of interest not only in benign diseases, but also especially in patients undergoing curative surgery for colorectal cancer, the largest group of patients undergoing open abdominal surgery.

Lena Holmdahl  Department of Surgery, Colorectal Unit, Sahlgrenska University Hospital/...stra, Guteborg University, Guteborg, S-416 85 Sweden

1. Edna TH, Bjerkeset T. Small bowel obstruction in patients previously operated on for colorectal cancer. Eur J Surg 1998; 164: 587-92.
2. Fazio VW, Ziv Y, Church JM, et al. Ileal pouch-anal anastomoses complications and function in 1005 patients. Ann Surg 1995; 222: 120- 27.
3. Ref LE. Causes of small intestinal obstruction. Acta Chir Scand 1969; 135: 67-72.
4. Buckman RF, Woods M, Sargent L, Gervin AS. A unifying pathogenetic mechanism in the etiology of intraperitoneal adhesions. J Surg Res 1976; 20: 1-5.
5. Raftery AT. Regeneration of peritoneum: a fibrinolytic study. J Anat 1979; 129: 659-64.
6. Thompson JN, Paterson Brown S, Harbourne T, Whawell SA, Kalodiki E, Dudley HAF. Reduced human peritoneal plasminogen activating activity: possible mechanism of adhesion formation. Br J Surg 1989; 76: 382-84.
7. Holmdahl L, Al-Jabreen M, Risberg B. The role of fibrinolysis in the formation of postoperative adhesions. Wound Rep Reg 1994; 7: 171-76.
8. Vipond MN, Whawell SA, Thompson JN, Dudley HA. Peritoneal fibrinolytic activity and intra-abdominal adhesions. Lancet 1990; 335:1120-22.
9. Holmdahl L, Eriksson E, Risberg B. Fibrinolysis in human peritoneum during operation. Surgery 1996; 119: 701-05.
10. Holmdahl L, Eriksson E, Eriksson BI, Risberg B. Depression of peritoneal fibrinolysis during surgery is a local response to trauma. Surgery 1998; 123: 539-44.
11. Ivarsson M-L, Holmdahl L, Eriksson E, Suderberg R, Risberg B. Expression and kinetics of fibrinolytic components in plasma and peritoneum during abdominal surgery. Fibrinolysis 1998; 12: 61-67.
12. Ivarsson M-L, Bergstrum M, Eriksson E, Risberg B, Holmdahl L. Tissue markers as predictors of post-surgical adhesions. Br J Surg 1998; 85: 1549-54.
13. Menzies D, Ellis H. Intestinal obstruction from adhesions :how big is the problem? Ann Roy Coll Surg Engl 1990; 72: 60-63.
14. Becker JM, Dayton MT, Fazio VW, et al. Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioresorbable membrane: a prospective randomized, double-blind multicenter study. J Am Coll Surg 1996; 183: 297-306.
15. Diamond MP, and The Seprafilm Study Group. Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Fertil Steril 1996; 66: 904-10. 
COPYRIGHT 1999 The Lancet Ltd.
COPYRIGHT 2000 Gale Group

Adhesions Lead To Too Many Readmissions - Brief Article

August, 1999

Adhesions Lead To Too Many Readmissions - Brief Article

In the first epidemiologic study of its kind, investigators in the Surgical and Clinical Adhesions Research (SCAR) study have shown that postoperative adhesions are directly related to a substantial number of hospital readmissions and result in a high rate of complications with potentially significant long-term consequences. Reporting in a recent issue of the Lancet, Ellis and associates urge that greater emphasis be placed on identifying surgical procedures with a high risk of adhesion-related complications and on assessing proposed adhesion prevention strategies.

Using the Scottish National Health Service medical record linkage database, the SCAR investigators identified 29,790 patients who underwent open abdominal or pelvic surgery in 1986 and had not had similar surgery in the previous 5 years. Over 10 years' follow-up, one in three (34.6%) of these patients was readmitted because of a disorder directly or possibly related to adhesions or for abdominal or pelvic surgery that could potentially be complicated by adhesions. Overall, 10,326 patients had one or more readmissions, totaling 21,347--a mean of 2.1 readmissions per patient.

Of the 21,347 readmissions, 1,209 (5.7%) were classified as directly related to adhesions, and 8,240 (38.6%) as possibly related to adhesions. The greatest percentage of all readmissions occurred in the first year after surgery (22.1%), but readmissions continued steadily thereafter.

Midgut and hindgut surgeries accounted for the highest percentage of readmissions directly related to adhesions (7.3%) and the highest rate of readmission (5.1 readmissions per 100 initial procedures). According to the investigators, strategies to prevent the formation of adhesions should be implemented during these procedures.

The authors also demonstrated the potential long-term effects of adhesions. In 1994, in the total database population of 5 million, they found that 4,199 individuals (5.6% of all 67,017 admitted for any reason that year) had adhesion-related admissions and 48,664 (64.7%) were admitted for causes possibly related to adhesions.

In a related commentary, Holmdahl applauds the SCAR investigators for calling attention to this issue. She notes the previous success of hyaluronic acid as a barrier to prevent the formation of fibrin bridges and subsequent adhesions.

Ellis H, Moran BJ, Thompson JN, et al. Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study. Lancet. 1999;353:1476-1480.

Holmdahl L. Making and covering of surgical footprints [commentary]. Lancet. 1999;353:1456-1457.
 
 

Rate of Adhesion-Related Complications High

Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort study

 Refers to:

                      Adhesion-related hospital readmissions after abdominal and pelvic surgery: a retrospective cohort
                      study, The Lancet, Volume 353, Issue 9163, 1 May 1999, Pages 1476-1480 
                      Harold Ellis, a, Brendan J Moranb, Jeremy N Thompsonc, Michael C Parkerd, Malcolm S Wilsone, Don
                      Menziesf, Alistair McGuireh, g, Adrian M Loweri et al.

                                                   Index Terms: peritoneum adhesion 

Coming soon:
This section is in progress
Additional Communications with National Health Departments: "Center of Disease Control" CDC 
with lots of material and graphs!

 
 
 
 
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