Gastric Cancer
Conditions
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.
Interventions
OTHERSeprafilm
two sheets per body
Sponsors
Nihon University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of small bowel obstruction | 3 years, more than 6 months after gastrectomy |
Secondary
| Measure | Time frame |
|---|---|
| intraoperative and postoperative morbidity and mortality. | 3 years |
Countries
Japan
Outcome results
None listed