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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 26, 2007 | ||||
| Last Updated Date | January 26, 2007 | ||||
| Start Date ICMJE | May 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
mortality and morbidity rates at three months - The primary end point was the rate of patients with at least one postoperative complications occurring during the first 90 days after the first initial procedure or dying postoperatively | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
functional results were assessed at 3 and 12 months after the first operation - Quality of life was measured using the Gastrointestinal Quality of Life Index (GICLI) | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Early Temporary Stoma Closure After Proctectomy | ||||
| Official Title ICMJE | Study of Early Closure of Temporary Loop Ileostomy After Elective Rectal Resection With Low Pelvic Anastomoses | ||||
| Brief Summary | We conducted a prospective randomized study to evaluate the results of early closure of temporary loop ileostomy at eight days in comparison with late closure at two months, after elective rectal resection with low pelvic anastomoses. |
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| Detailed Description | The aim of this multicentric prospective randomized study is to compare for patients requiring rectal resection followed by under Douglassienne anastomosis (low colorectal, coloanal, ileoanal) protected by ileostomy, two strategies about delay of ileostomy closing : delayed closing of ileostomy when second hospitalization two months later (classical attitude) ; precocious closing of ileostomy during the same hospitalization (at Day 8 of first operation). All patients aged 18 years or older with disease (carcinoma, inflammatory bowel disease, benign disease) requiring colorectal or rectal resection with low pelvic anastomoses (LPA) (ie low colorectal, coloanal, or ileoanal procedures) were eligible to participate in the study. A water-soluble contrast enema examination through temporary loop ileostomy was performed at day 7. If there were no radiologic signs of contrast leakage, patients were allotted to the group of early closure (EC) or to the group of late closure (LC). The primary end point was the rate of either postoperative death or postoperative complications occurring at 90 days after the first initial procedure.Postoperative complications will be considered present for a patient if one of the following elements is observed during the study : post operative death, anastomotic fistula, postoperative peritonitis ; serious event requiring hospitalization : prolapsus or peristomial eventration, erosive peristomial dermitis, serious wall sepsis, dehydration with hydroelectrolytic disorders, occlusive syndrome. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Ileostomy | ||||
| Intervention ICMJE | Procedure: ileostomy | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Alves A, Panis Y, Lelong B, Dousset B, Benoist S, Vicaut E. Randomized clinical trial of early versus delayed temporary stoma closure after proctectomy. Br J Surg. 2008 Jun;95(6):693-8. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 270 | ||||
| Completion Date | July 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00428636 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | AOM 00154 | ||||
| Study Sponsor ICMJE | Assistance Publique - Hôpitaux de Paris | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||
| Verification Date | January 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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