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Sponsored by: |
Nihon Univerity |
---|---|
Information provided by: | Nihon Univerity |
ClinicalTrials.gov Identifier: | NCT00529412 |
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 |
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 |
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
|
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.
Ages Eligible for Study: | up to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan | |
Department of Digestive Surgery, NIhon University School of Medicine | |
Tokyo, Japan, 173-8610 |
Study Chair: | Tadatoshi Takayama, MD, PhD | Department of Digestive Surgery, Nihon University School of Medicine |
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 |
Intestinal Obstruction Stomach Diseases Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Stomach Neoplasms Gastrointestinal Neoplasms Stomach cancer Intestinal Diseases |
Neoplasms Neoplasms by Site |