Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial
N/A
79 Years
Both
Gastric Cancer
Trial Information
Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
incidence of small bowel obstruction
Outcome Time Frame:
3 years, more than 6 months after gastrectomy
Principal Investigator
Tadatoshi Takayama, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Department of Digestive Surgery, Nihon University School of Medicine
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
NUSM-CC-01
NCT ID:
NCT00529412
Start Date:
August 2003
Completion Date:
March 2007
Related Keywords:
- Gastric Cancer
- Intestinal Obstruction
- Stomach Neoplasms
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