Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

Phase 3

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT00529412
• Lead Sponsor: Nihon University

Brief Summary

To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in patients who underwent surgery for gastric cancer.

Detailed Description

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.

Study Timeline

• Study Start: 2003-08
• Study Completion: 2007-03
• Status Verified: 2007-06
• Study First Submitted: 2007-09-13
• Study First Submitted QC: 2007-09-13
• Last Update Submitted: 2007-09-13
• Study First Posted: 2007-09-14
• Last Update Posted: 2007-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
incidence of small bowel obstruction	3 years, more than 6 months after gastrectomy

Secondary Outcome Measures

Name	Time	Method
intraoperative and postoperative morbidity and mortality.	3 years

Trial Locations

Locations (1)

Department of Digestive Surgery, NIhon University School of Medicine; 🇯🇵 Tokyo, Japan