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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
  Purpose

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


Condition Intervention Phase
Gastric Cancer
 Other: Seprafilm
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nihon University:

Primary Outcome Measures:
  • incidence of small bowel obstruction [ Time Frame: 3 years, more than 6 months after gastrectomy ]

Secondary Outcome Measures:
  • intraoperative and postoperative morbidity and mortality. [ Time Frame: 3 years ]

Enrollment: 150
Study Start Date: August 2003
Study Completion Date: March 2007
Arms Assigned Interventions
No Intervention: control
no Seprafilm
 Other: Seprafilm
two sheets per body
Active Comparator: Seprafilm Other: Seprafilm
two sheets per body

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.

  Eligibility

Ages Eligible for Study:   up to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00529412

Locations
Japan
Department of Digestive Surgery, NIhon University School of Medicine
Tokyo, Japan, 173-8610
Sponsors and Collaborators
Nihon University
Investigators
Study Chair: Tadatoshi Takayama, MD, PhD Department of Digestive Surgery, Nihon University School of Medicine
  More Information

No publications provided by Nihon University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00529412     History of Changes
Other Study ID Numbers: NUSM-CC-01
Study First Received: September 13, 2007
Last Updated: September 13, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Intestinal Obstruction
Stomach Neoplasms
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Stomach Diseases

ClinicalTrials.gov processed this record on May 16, 2013