Objective To assess the effectiveness of bioresorbable Seprafilm membrane in preventing abdominal adhesions in a prospective clinical randomized multicenter trial. Summary Background Data Adhesions occur frequently after abdominal operations and are a common cause of bowel obstruction, chronic abdominal pain, and infertility. To reduce the formation of adhesions, a mechanical barrier composed of hyaluronic acid and carboxymethylcellulose was developed, preventing adherence of tissues after abdominal surgery. Methods Between April 1996 and September 1998, all patients requiring a Hartmann procedure for sigmoid diverticulits or obstructed rectosigmoid were randomized to either intraperitoneal placement of the antiadhesions membrane under the midline during laparotomy and in the pelvis, or as a control. Direct visual evaluation of the incidence and severity of adhesions was performed laparoscopically at second-stage surgery for restoration of the continuity of the colon. Results A total of 71 patients were randomized; of these, 42 could be evaluated. The Incidence of adhesions did not differ significantly between the two groups, but the severity of adhesions was significantly reduced in the Seprafilm group both for the midline incision and for the pelvic area. Complications occurred in similar numbers in both groups, Conclusions Seprafilm antiadhesions membrane appears effective in reducing the severity of postoperative adhesions after major abdominal surgery, although the incidence of adhesions was not diminished. The authors recommend using Seprafilm when relaparotomy or second-look intervention is planned. Long-term studies are needed to assess the cost-effectiveness and value of Seprafilm in preventing bowel obstruction, chronic abdominal pain, and infertility.
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Lehigh Valley Hlth Network, Dept Obstet & Gynecol, Allentown, PA USA
Winthrop Univ Hosp, Dept Obstet & Gynecol, Mineola, NY 11501 USA
SUNY Stony Brook, Dept Obstet Gynecol & Reprod Med, Stony Brook, NY 11794 USALehigh Valley Hlth Network, Dept Obstet & Gynecol, Allentown, PA USA
Kiefer, Daniel G.
Muscat, Jolene C.
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Winthrop Univ Hosp, Dept Obstet & Gynecol, Mineola, NY 11501 USALehigh Valley Hlth Network, Dept Obstet & Gynecol, Allentown, PA USA
Muscat, Jolene C.
Santorelli, Jarrett
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SUNY Stony Brook, Dept Obstet Gynecol & Reprod Med, Stony Brook, NY 11794 USA
SUNY Buffalo, Dept Surg, Buffalo, NY 14260 USALehigh Valley Hlth Network, Dept Obstet & Gynecol, Allentown, PA USA
Santorelli, Jarrett
Chavez, Martin R.
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Winthrop Univ Hosp, Dept Obstet & Gynecol, Mineola, NY 11501 USALehigh Valley Hlth Network, Dept Obstet & Gynecol, Allentown, PA USA
Chavez, Martin R.
Ananth, Cande V.
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Columbia Univ, Coll Phys & Surg, Dept Obstet Gynecol, New York, NY USA
Columbia Univ, Mailman Sch Publ Hlth, Dept Epidemiol, New York, NY USALehigh Valley Hlth Network, Dept Obstet & Gynecol, Allentown, PA USA
Ananth, Cande V.
Smulian, John C.
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Lehigh Valley Hlth Network, Dept Obstet & Gynecol, Allentown, PA USALehigh Valley Hlth Network, Dept Obstet & Gynecol, Allentown, PA USA
Smulian, John C.
Vintzileos, Anthony M.
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Winthrop Univ Hosp, Dept Obstet & Gynecol, Mineola, NY 11501 USALehigh Valley Hlth Network, Dept Obstet & Gynecol, Allentown, PA USA
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Catholic Univ Korea, Coll Med, Seoul St Marys Hosp, Dept Urol, Seoul, South KoreaCatholic Univ Korea, Coll Med, Seoul St Marys Hosp, Dept Urol, Seoul, South Korea
Ha, U-Syn
Koh, Jun Sung
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Catholic Univ Korea, Coll Med, Bucheon St Marys Hosp, Dept Urol, Seoul, South Korea
Catholic Univ Korea, Coll Med, Bucheon St Marys Hosp, Dept Urol, 327 Sosa Ro, Bucheon Si 14647, Gyeonggi Do, South KoreaCatholic Univ Korea, Coll Med, Seoul St Marys Hosp, Dept Urol, Seoul, South Korea
Koh, Jun Sung
Cho, Kang Jun
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Catholic Univ Korea, Coll Med, Bucheon St Marys Hosp, Dept Urol, Seoul, South KoreaCatholic Univ Korea, Coll Med, Seoul St Marys Hosp, Dept Urol, Seoul, South Korea
Cho, Kang Jun
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Yoon, Byung Il
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Lee, Kyu Won
Hong, Sung Hoo
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Catholic Univ Korea, Coll Med, Seoul St Marys Hosp, Dept Urol, Seoul, South KoreaCatholic Univ Korea, Coll Med, Seoul St Marys Hosp, Dept Urol, Seoul, South Korea