Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00529412
Recruitment Status : Completed
First Posted : September 14, 2007
Last Update Posted : September 14, 2007
Information provided by:
Nihon University

September 13, 2007
September 14, 2007
September 14, 2007
August 2003
Not Provided
incidence of small bowel obstruction [ Time Frame: 3 years, more than 6 months after gastrectomy ]
Same as current
No Changes Posted
intraoperative and postoperative morbidity and mortality. [ Time Frame: 3 years ]
Same as current
Not Provided
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Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction
Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial
To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in patients who underwent surgery for gastric cancer.
Patients with gastric cancer who were scheduled to undergo gastrectomy were randomly assigned to a sodium hyaluronate-based bioresorbable membrane (Seprafilm) group or to a control group. Before closing the abdominal incision, two sheets of Seprafilm membrane were applied to the surface of the small intestine under the middle abdominal wound in the Seprafilm group. The primary end point was the incidence of bowel obstruction. Secondary end points were intraoperative and postoperative morbidity and mortality.
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Gastric Cancer
Other: Seprafilm
two sheets per body
  • No Intervention: control
    no Seprafilm
    Intervention: Other: Seprafilm
  • Active Comparator: Seprafilm
    Intervention: Other: Seprafilm
Hayashi S, Takayama T, Masuda H, Kochi M, Ishii Y, Matsuda M, Yamagata M, Fujii M. Bioresorbable membrane to reduce postoperative small bowel obstruction in patients with gastric cancer: a randomized clinical trial. Ann Surg. 2008 May;247(5):766-70. doi: 10.1097/SLA.0b013e3181656d4e.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2007
Not Provided

Inclusion Criteria:

  • Clinical diagnosis of gastric cancer
  • Operable

Exclusion Criteria:

  • Withdrew consent
  • Pregnant
  • Ascites
  • Distant metastasis
  • Liver dysfunction (serum total bilirubin >2.0 mg/dL)
  • Renal failure (serum creatinine >1.5 mg/dL)
  • A past history of small bowel obstruction.
Sexes Eligible for Study: All
up to 79 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Nihon University
Not Provided
Study Chair: Tadatoshi Takayama, MD, PhD Department of Digestive Surgery, Nihon University School of Medicine
Nihon University
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP