Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction
This study has been completed.
Sponsor:
Nihon University
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
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2007 | ||||
| Last Updated Date | September 13, 2007 | ||||
| Start Date ICMJE | August 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
incidence of small bowel obstruction [ Time Frame: 3 years, more than 6 months after gastrectomy ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
intraoperative and postoperative morbidity and mortality. [ Time Frame: 3 years ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction | ||||
| Official Title ICMJE | Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial | ||||
| Brief Summary | To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in patients who underwent surgery for gastric cancer. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Gastric Cancer | ||||
| Intervention ICMJE | Other: Seprafilm
two sheets per body |
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| Study Arm (s) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 150 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 79 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00529412 | ||||
| Other Study ID Numbers ICMJE | NUSM-CC-01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Nihon University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nihon University | ||||
| Verification Date | June 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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