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Paradoxical inflammatory reaction to Seprafilm: case report and review of the literature.



Abstract: This report describes a paradoxical inflammatory reaction to Seprafilm caused by extensive adhesion formation early in the postoperative period. A female patient had development of small bowel obstruction immediately after an uneventful low anterior resection for rectal carcinoma with placement of Seprafilm. The obstruction did not improve with nonoperative therapy. At laparotomy laparotomy /lap·a·rot·o·my/ (-rot´ah-me) incision through the flank or, more generally, through any part of the abdominal wall.

lap·a·rot·o·my
n.
1.
, extensive adhesions necessitating bowel resection and ileostomy ileostomy /il·e·os·to·my/ (il?e-os´tah-me) surgical creation of an opening into the ileum, with a stoma on the abdominal wall.

il·e·os·to·my
n.
1.
 were noted. Pathology results showed a giant cell foreign body reaction to Seprafilm. A literature search yielded only two other instances of adverse reactions to Seprafilm. The information provided by this and other atypical reports suggests that further studies aimed at identifying the incidence and pathophysiological mechanisms for such paradoxical reactions are needed.

Key Words: Seprafilm, paradoxical adhesion, bowel obstruction, peritonitis peritonitis (pĕr'ĭtənī`tĭs), acute or chronic inflammation of the peritoneum, the membrane that lines the abdominal cavity and surrounds the internal organs.  

**********

It is estimated that postoperative adhesions occur in 67 to 93% of patients undergoing abdominal or pelvic surgery. (1,2) Such adhesions can lead to complications including small bowel obstruction (49 to 74%), infertility (15 to 20%), and chronic pelvic pain Women and Pelvic pain
Most women (and some men), at some time in their lives, experience pelvic pain. When the condition persists for longer than 3 months, it is called chronic pelvic pain (CPP).
 (20 to 50%). (3,4) Although the pathophysiology of adhesion formation is not completely understood, numerous surgical adjuncts have been introduced in recent years to decrease the incidence and clinical implication of adhesions. One such method involves the use of a bioabsorbable adhesion barrier composed of sodium hyaluronate hyaluronate /hy·al·uro·nate/ (hi?ah-ldbobr´ro-nat) a salt, anion, or ester of hyaluronic acid. The sodium salt and a derivative of it are used as analgesics in the treatment of osteoarthritis of the knee.  and carboxymethylcellulose carboxymethylcellulose /car·boxy·meth·yl·cel·lu·lose/ (-meth?il-sel´u-los) a substituted cellulose polymer of variable size, used as the sodium or calcium salt as a pharmaceutical suspending agent, tablet excipient, and  (Seprafilm, Genzyme Corp, Cambridge, MA). Two randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
, blinded, controlled clinical trials and a prospective study have demonstrated both its safety and efficacy in preventing adhesions in abdominal and pelvic surgeries. (5-7) We report a case of extensive inflammatory reaction in a patient in whom Seprafilm was used during an uncomplicated low anterior resection. An extensive literature search yielded only two other case reports of paradoxical adverse reactions to this adhesion barrier. (8,9)

Case Report

A 70-year-old female was referred for a low anterior resection for a rectal tumor located 10 cm from the anal verge. Her medical history was significant for hypertension and asthma. Her surgical history included a total abdominal hysterectomy to·tal abdominal hysterectomy
n. Abbr. TAH
An abdominal hysterectomy in which the uterus and cervix are removed.


total abdominal hysterectomy 
 for uterine fibroids in 1975, a bladder lift in 1976, and a right oophorectomy Oophorectomy Definition

Oophorectomy is the surgical removal of one or both ovaries. It is also called ovariectomy or ovarian ablation. If one ovary is removed, a woman may continue to menstruate and have children.
 in 2002 for benign disease. At surgery, the scant adhesions from the prior surgeries were lysed and the low anterior resection proceeded uneventfully. A colorectal anastomosis was created and a sheet of Seprafilm was placed between the omentum omentum /omen·tum/ (o-men´tum) pl. omen´ta   [L.] a fold of peritoneum extending from the stomach to adjacent abdominal organs.

colic omentum , gastrocolic omentum greater o.
 and the incision during closure. The final pathology showed stage II (T2, N0, M0) adenocarcinoma.

Her postoperative course was marked by a mild tachycardia of 95 to 105 and a low-grade temperature of 100 to 100.5[degrees]F. She reported no abdominal pain, and her white blood cell count white blood cell count,
n a diagnostic clinical laboratory test to determine the number and types of leukocytes present in a measured sample of blood. Overall the normal number of leukocytes ranges from 5000 to 10,000/mm3.
 was normal. On postoperative day 4, the patient was noted to be very distended distended Medtalk Enlarged, bloated. Cf Nondistended.  and nauseated nau·se·at·ed
adj.
Affected with nausea.
. A Gastrografin enema did not reveal an anastomotic leak and an abdominal CT scan did not reveal an abscess. A nasogastric tube was placed, and the patient was followed expectantly. Her distention dis·ten·tion or dis·ten·sion
n.
The act of distending or the state of being distended.


distention,
n a state of dilation.
 and inability to tolerate oral intake did not improve, although she was not febrile and had a normal white count and differential. Because of her unresolving obstruction, she was returned to the operating room on postoperative day 11.

At laparotomy, she was found to have extensive, dense adhesions involving the abdominal wall, omentum, and multiple loops of small bowel. There were several sites of obstruction with proximal dilation within this mass of adhesed loops. These loops were fused together in several sites, which prevented separation. The adhesions were lysed; however, four enterotomies were created, necessitating an ileocecectomy with a partial omentectomy and ileostomy. The previously created colorectal anastomosis appeared to be intact. However, two loops of ileum ileum: see intestine.
ileum

Final and longest segment of the small intestine. It is the site of absorption of vitamin B12 (see vitamin B complex) and reabsorption of about 90% of conjugated bile salts.
 were densely adhered to the anastomotic site and so the anastomosis was taken down with the lysis of adhesions. An end-descending colostomy colostomy

Surgical formation of an artificial anus by making an opening from the colon through the abdominal wall. It may be done to decompress an obstructed colon, to allow excretion when part of the colon must be removed, or to permit healing of the colon.
 and rectal Hartmann closure was performed. The pathology showed diffuse inflammation with multiple giant cells suggesting a foreign body reaction (Figs. 1 and 2). The patient recovered well and was ultimately transferred to a rehabilitation facility. She was doing well at her 6-week visit.

Discussion

Postoperative adhesions form after most intraperitoneal procedures. Sixty-seven percent of patients undergoing laparotomy have development of adhesions, according to autopsy studies conducted by Weibel and Majno. (1) After multiple operations, this incidence rises to 93%, as demonstrated in the prospective clinical trial performed by Menzies and Ellis. (2) Such adhesions can cause numerous complications, costing substantial healthcare dollars. According to the National Inpatient Profile, more than 400,000 laparotomies were performed for lysis of adhesions in 1993 in the United States.

The precise cause of adhesion formation is not completely understood, although numerous methods have been used to prevent this complication, including mechanical barriers. Seprafilm is composed of two anionic polysaccharides, sodium hyaluronate and carboxymethylcellulose, which have been chemically modified. This barrier transforms into a gel after being placed in the peritoneum peritoneum (pĕrətənē`əm), multilayered membrane which lines the abdominal cavity, and supports and covers the organs within it. The part of the membrane that lines the abdominal cavity is called the parietal peritoneum.  and is reabsorbed in approximately 7 days, after normal tissue repair has taken place and the inflammatory cascade has subsided. It thus prevents adhesions by physically separating raw surfaces temporarily. In two prospective, randomized, blinded, multicenter studies in which Seprafilm was used after pelvic or abdominal surgery, repeat laparotomy or laparoscopy laparoscopy
 or peritoneoscopy

Procedure for inspecting the abdominal cavity using a laparoscope; also surgery requiring use of a laparoscope. Laparoscopes use fibre-optic lights and small video cameras to show tissues and organs on a monitor.
 showed a significantly lower rate of adhesion formation and no difference in adverse events in patients who received the membrane and those that did not. (5,6)

Beck et al (7) studied patients undergoing abdominopelvic surgery, the majority of whom had inflammatory bowel disease inflammatory bowel disease
n. Abbr. IBD
Any of several incurable and debilitating diseases of the gastrointestinal tract characterized by inflammation and obstruction of parts of the intestine.
, and reported an increased incidence of peritonitis (3% Seprafilm versus 1% control). However, the degree to which anastomotic leak contributed to their findings was not clear. An extensive review of the literature for adverse reactions to Seprafilm yielded only two other case studies. Klinger et al (9) published a report on Seprafilm-induced peritoneal inflammation in a patient who had undergone completion proctocolectomy. This patient had a fever and partial small bowel obstruction on postoperative day 4. (10,11) On exploratory laparotomy, an area of intense inflammation corresponding to the site of Seprafilm placement was observed. Histologic examination revealed a foreign body granulomatous granulomatous /gran·u·lom·a·tous/ (-lom´ah-tus) containing granulomas.
Granulomatous
Resembling a tumor made of granular material.
 reaction. In addition, Remzi et al (8) reported similar observations in three patients who underwent various colorectal surgeries and received Seprafilm.

[FIGURE 1 OMITTED]

[FIGURE 2 OMITTED]

Conclusion

The high incidence of postoperative adhesion formation and the morbidity associated with its complications warrant the use of adjuncts such as mechanical barriers. Seprafilm is clinically proven to be safe and effective in preventing adhesion formation. Rarely, however, this substance may cause an intense inflammatory response that resembles peritonitis or may cause a bowel obstruction. Because these findings are uncommon, increased reporting will better clarify the incidence and help identify the cause of such paradoxical reactions.

References

1. Weibel M, Majno G. Peritoneal peritoneal /peri·to·ne·al/ (per?i-to-ne´al) pertaining to the peritoneum.

peritoneal

pertaining to the peritoneum.
 adhesions and their relation to abdominal surgery. Am J Surg 1973;126:345-353.

2. Menzies D, Ellis H. Intestinal obstruction from adhesions--how big is the problem? Ann R Coll Surg Engl 1990;72:60-63.

3. Hershlag A, Diamond M, DeCherney A. Adhesiolysys. Clin Obstet Gynecol 1991;34:395-401.

4. Monk B, Berman M, Montz F. Adhesions after extensive gynecologic surgery: clinical significance, etiology, and preventions. Am J Obstet and Gynecol 1994;170:1393-1403.

5. Diamond M. Reduction of adhesions after uterine myomectomy by Seprafilm Membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Fertility and Sterility 1996;66:904-910.

6. Becker J, Dayton M, Fazio VW, et al. Prevention of postoperative abdominal adhesions by a sodium hyaluronate-based bioreabsorbable membrane: a prospective, randomized, double-blinded multicenter study. J Am Coll Surg 1996;183:297-306.

7. Beck DE, Cohen cohen
 or kohen

(Hebrew: “priest”) Jewish priest descended from Zadok (a descendant of Aaron), priest at the First Temple of Jerusalem. The biblical priesthood was hereditary and male.
 Z, Gleshman JW, et al. A prospective, randomized, multicenter, controlled study of the safety of Seprafilm adhesion barrier in abdominopelvic surgery of the intestine. Dis Colon Rectum 2003;46:1310-1319.

8. Remzi FH, Oncel M, Church JM, et al. An unusual complication after hyaluronate-based bioresorbable membrane (Seprafilm) application. Am Surg 2003;69:356-357.

9. Klingler PJ, Floch NR, Seelig MH, et al. Seprafilm-induced peritoneal inflammation: A previously unknown complication: Report of a case. Dis Colon Rectum 1999;42:1639-1643.

10. Boys F. The prophylaxis of peritoneal adhesions: A review of the literature. Surgery 1942;11:118-168.

11. Harold E. The causes and prevention of intestinal adhesions. Br J Surg 1982;69:241-243.
Of science and the human heart, there is no limit.
--U2


Marianne David, BS, Babak Sarani, MD, Farah Moid, MD, Sana Tabbara, MD, and Bruce A. Orkin, MD, FACS FACS Fellow of the American College of Surgeons.

FACS
abbr.
Fellow of the American College of Surgeons



FACS

fluorescence-activated cell sorter.
 

From the Department of Surgery and the Department of Pathology, George Washington University George Washington University, at Washington, D.C.; coeducational; chartered 1821 as Columbian College (one of the first nonsectarian colleges), opened 1822, became a university in 1873, renamed 1904. , Washington, DC.

Reprint requests to Bruce Orkin, MD, George Washington University, 2150 Pennsylvania Avenue NW, Washington, DC 20037. E-mail: borkin@mfa.gwu.edu

Accepted March 17, 2005.

RELATED ARTICLE: Key Points

* Seprafilm has been proven to be a safe and effective adhesion barrier after abdominopelvic surgery.

* Rare adverse inflammatory reactions to Seprafilm indicate that certain predisposing factors might exist that contribute to this phenomenon.

* Given the widespread use of adhesion barriers in abdominopelvic surgical procedures, further experimental studies are warranted for investigating the underlying pathophysiological mechanisms for these aberrant inflammatory reactions.
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Title Annotation:Case Report
Author:Orkin, Bruce A.
Publication:Southern Medical Journal
Date:Oct 1, 2005
Words:1480
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