SEPRAFILM® and General Surgery

Adhesions are a common consequence of open surgery, forming in 93% of patients who undergo abdominal laparotomy.¹ Adhesions account for up to:

• 75% of small bowel obstructions²
• 40% of infertility cases³
• 48% of chronic pelvic pain cases⁴

Adhesions to prior incisions and surgical sites may also increase the complexity of future surgeries. In the worst cases, multiple, dense adhesions can completely obscure access to the abdominal cavity, often referred to as “concrete abdomen.”

"Concrete abdomen" - cohesive adhesions between loops of small bowel

The effects of adhesions on subsequent surgery include:

• Increased procedure and re-entry time⁵
• Difficulty differentiating and accessing tissue planes⁶
• Increased risk of inadvertent enterotomy⁷
• Potential reoperation for small bowel obstruction⁸

Adhesions can also limit and complicate future treatment options, including laparoscopy⁶, radiotherapy⁹, and intraperitoneal chemotherapy.⁶

SEPRAFILM Adhesion Barrier is proven to help prevent postoperative adhesions.¹⁰

No adhesion barrier has been evaluated more extensively in abdominopelvic surgery.¹² SEPRAFILM is proven safe in the presence of an anastomosis and is proven to provide clinical benefit at bowel resection, ostomy creation, and radical pelvic surgery when used as directed (see Important Safety Information below). In a series of prospective clinical trials, SEPRAFILM placement at a primary procedure was shown to significantly reduce reoperative complexity, including inadvertent injury and operative time.^11,13 In a large randomized, controlled trial of patients receiving SEPRAFILM at intestinal resection, SEPRAFILM reduced the incidence of reoperative adhesive small bowel obstruction (SBO) by 47%.⁸

Open procedures in which SEPRAFILM can be applied include¹⁰:

• Surgery for inflammatory bowel disease
• Radical abdominopelvic surgery 
• Exploratory laparotomy
• Ileostomy creation and closure
• Hartmann’s procedure
• Small bowel resection
• Right hemicolectomy
• Left hemicolectomy
• Sigmoid colectomy
• Ileal pouch creation
• Low anterior resection
• Abdominoperitoneal resection
• Bariatric surgery
• Hepatobiliary and pancreatic surgery
• Gastric resection
• Liver resection
• Hernia repair

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

 

10. SEPRAFILM Prescribing Information. Cambridge, MA: Genzyme Biosurgery; 2007.

 

10. SEPRAFILM Prescribing Information. Cambridge, MA: Genzyme Biosurgery; 2007.

 

11. Tang C-L, Seow-Choen F, Fook-Chong S, Eu K-W. Bioresorbable adhesion barrier facilitates early closure of the defunctioning ileostomy after rectal excision. Dis Colon Rectum. 2003;46:1200-1207.

 

12. Data on file. Genzyme Biosurgery

 

13. Kusunoki M, Ikeuchi H, Yanagi H, et al. Bioresorbable hyaluronate-carboxymethylcellulose membrane (Seprafilm) in surgery for rectal carcinoma: a prospective randomized clinical trial. Surg Today. 2005;35:940-945.

 

2. Scovill WA. Small bowel obstruction. In: Cameron JL, ed. Current Therapy in Surgery. St Louis, MO: Mosby Yearbook Medical Publishers, Inc; 1995:100-104.

 

3. DiZerega GS.  Peritoneal repair and postsurgical adhesion formation. In: Management of Common Problems in Obstetrics & Gynecology. Mishell DR, Goodwin Murphy T, Brenner PF, eds. Malden, MA: Blackwell Publishing; 2002: 267-271.

 

4. Stovall TG, Elder RF, Ling FW. Predictors of pelvic adhesions. J Reprod Med. 1989; 34:345-348.

 

5. Ellis H, Moran BJ, Thompson JN, Parker MC, Wilson MS, Menzies D, et al.  Adhesion-related hospital readmissions after abdominal and pelvic surgery:  a retrospective cohort study.Lancet1999;353(9163):1476-1480.

 

6. Nichols DH, Clarke-Pearson DL, eds. Gynecologic, Obstetric, and Related Surgery. 2^nd ed. St. Louis, MO: Mosby, Inc; 1993.

 

6. Nichols DH, Clarke-Pearson DL, eds. Gynecologic, Obstetric, and Related Surgery. 2^nd ed. St. Louis, MO: Mosby, Inc; 1993.

 

6. Nichols DH, Clarke-Pearson DL, eds. Gynecologic, Obstetric, and Related Surgery. 2^nd ed. St. Louis, MO: Mosby, Inc; 1993.

 

7. Van der Krabben AA, Dijkstra FR, Nieuwenhuijzen M, Reijnen MMPJ, Schaapveld M, van Goor H. Morbidity and mortality of inadvertent enterotomy during adhesiotomy. Br J Surg. 2000;87(4):467-471.

 

8. Fazio VW, Cohen Z, Fleshman JW, et al. Reduction in adhesive small-bowel obstruction by Seprafilm Adhesion Barrier after intestinal resection. Dis Colon Rectum. 2005;49:1-11.

 

8. Fazio VW, Cohen Z, Fleshman JW, et al. Reduction in adhesive small-bowel obstruction by Seprafilm Adhesion Barrier after intestinal resection. Dis Colon Rectum. 2005;49:1-11.

 

9. Eifel PF.  Radiation therapy. In: Berek JS, Hacker NF, eds. Practical Gynecologic Oncology, 4th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005: 119-161.