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SEPRAFILM® and Radical Abdominopelvic Surgery

Adhesions are of particular concern following radical pelvic surgery, including resection of the small bowel, colon, and rectum, given the risk of adhesive small bowel obstruction. Adhesions may also complicate subsequent surgery1, staged or unplanned, and limit future treatment options including laparoscopy2, radiotherapy3, and intraperitoneal chemotherapy.2 Adhesions may also lead to infertility4 and chronic pelvic pain.5

SEPRAFILM has been proven to reduce adhesions, leading to:

  • Reduced incidence of reoperative adhesive small bowel obstruction6
  • Reduced reoperative complexity7,8
  • Easier ileostomy reversal8
  • A 75% reduction in the incidence of dense postoperative adhesions9

In a post-market study, SEPRAFILM was proven safe when used in bowel resection (up to 10 sheets were used), even in the presence of a bowel anastomosis, and did not increase the complication rate when the bowel anastomosis was not wrapped.10 SEPRAFILM should not be wrapped around a bowel anastomosis. See important safety information below.

Click here for relevant clinical studies.

SEPRAFILM application sites in low anterior resection11:

  • Traumatized descending colon
  • Pelvic peritoneal defect
  • Mesentery
  • Paracolic sidewall
  • Midline incision
  • Omentum

SEPRAFILM application sites in abdominoperineal resection11:

  • Lateral to stoma site
  • Pelvic peritoneal defect
  • Paracolic sidewall
  • Mesentery
  • Midline
  • Omentum

1. 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. Lancet 1999;353(9163):1476-1480.
 
10. Beck DE, Cohen Z, Fleshman JW, Kaufman HS, van Goor H, Wolff BG, for the Adhesion Study Group Steering Committee. 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.
 
11. SEPRAFILM Prescribing Information. Cambridge, MA: Genzyme Biosurgery; 2007.
 
11. SEPRAFILM Prescribing Information. Cambridge, MA: Genzyme Biosurgery; 2007.
 
2. Nichols DH, Clarke-Pearson DL, eds. Gynecologic, Obstetric, and Related Surgery. 2nd ed. St. Louis, MO: Mosby, Inc; 1993.
 
2. Nichols DH, Clarke-Pearson DL, eds. Gynecologic, Obstetric, and Related Surgery. 2nd ed. St. Louis, MO: Mosby, Inc; 1993.
 
3. Eifel PF.  Radiation therapy. In: Berek JS, Hacker NF, eds. Practical Gynecologic Oncology, 4th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005: 119-161.
 
4. 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.
 
5. Keltz MD, Gera PS, Olive DL. Prospective randomized trial of right-sided paracolic adhesiolysis for chronic pelvic pain. JSLS. 2006;10(4):443-446.
 
6. 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.
 
7. 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.
 
8. 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.
 
8. 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.
 
9. 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.
 

 

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Important Safety Information

Seprafilm® Adhesion Barrier is indicated for the reduction of post-surgical adhesions in patients undergoing abdominal or pelvic laparotomy. The type and frequency of adverse events reported are consistent with events typically seen following surgery when used as directed. Seprafilm should not be wrapped around an intestinal anastomosis as such usage may result in increased anastomotic leak related events. For important safety information, please see package insert.

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