Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction
Phase 3
Completed
- Conditions
- Gastric Cancer
- Interventions
- Other: Seprafilm
- 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.
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
- Arm && Interventions
Group Intervention Description control Seprafilm no Seprafilm Seprafilm Seprafilm -
- 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