Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction - Full Text View

Sponsored by:	Nihon Univerity
Information provided by:	Nihon Univerity
ClinicalTrials.gov Identifier:	NCT00529412

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 III

MedlinePlus related topics: Cancer Stomach Cancer

U.S. FDA Resources

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

Further study details as provided by Nihon Univerity:

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
control: No Intervention no Seprafilm	Other: Seprafilm two sheets per body
Seprafilm: Active Comparator	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 Univerity

Investigators

Study Chair:

Tadatoshi Takayama, MD, PhD

Department of Digestive Surgery, Nihon University School of Medicine

More Information

Publications indexed to this study:

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.

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

Study placed in the following topic categories:

Intestinal Obstruction
Stomach Diseases
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

Stomach Neoplasms
Gastrointestinal Neoplasms
Stomach cancer
Intestinal Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009