Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

Nihon University

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Other: Seprafilm

Study type: Interventional

Funder types: Other

Identifiers

NCT00529412

NUSM-CC-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: Under 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

control

No Intervention group

Description:

no Seprafilm

Treatment:

Other: Seprafilm

Seprafilm

Active Comparator group

Treatment:

Other: Seprafilm