Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction

This study has been completed.
Sponsor:
Information provided by:
Nihon University
ClinicalTrials.gov Identifier:
NCT00529412
First received: September 13, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted

September 13, 2007
September 13, 2007
August 2003
Not Provided
incidence of small bowel obstruction [ Time Frame: 3 years, more than 6 months after gastrectomy ]
Same as current
No Changes Posted
intraoperative and postoperative morbidity and mortality. [ Time Frame: 3 years ]
Same as current
Not Provided
Not Provided
 
Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction
Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial

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

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Gastric Cancer
Other: Seprafilm
two sheets per body
  • No Intervention: control
    no Seprafilm
    Intervention: Other: Seprafilm
  • Active Comparator: Seprafilm
    Intervention: Other: Seprafilm
Hayashi S, Takayama T, Masuda H, Kochi M, Ishii Y, Matsuda M, Yamagata M, Fujii M. Bioresorbable membrane to reduce postoperative small bowel obstruction in patients with gastric cancer: a randomized clinical trial. Ann Surg. 2008 May;247(5):766-70.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
March 2007
Not Provided

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.
Both
up to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00529412
NUSM-CC-01
Yes
Not Provided
Nihon University
Not Provided
Study Chair: Tadatoshi Takayama, MD, PhD Department of Digestive Surgery, Nihon University School of Medicine
Nihon University
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP