Early Temporary Stoma Closure After Proctectomy

Not Applicable

Completed

• Conditions: Ileostomy

• Registration Number: NCT00428636
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

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.

Study Timeline

• Study Start: 2001-05
• Study Completion: 2005-07
• Status Verified: 2007-01
• Study First Submitted: 2007-01-26
• Study First Submitted QC: 2007-01-26
• Last Update Submitted: 2007-01-26
• Study First Posted: 2007-01-30
• Last Update Posted: 2007-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• All patients were aged 18 years or older ; there was no upper limit for age.
• All patients with disease (carcinoma, inflammatory bowel disease, benign disease) requiring elective rectal resection with low pelvic anastomosis (ie low colorectal, coloanal, or ileoanal procedures)
• Written informed consent was obtained from all patients

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (3)

Hôpital AMBROISE PARE - Service de Chirurgie Digestive; 🇫🇷 Billancourt, Ile de France, France

Hôpital Cochin - Service de Chirurgie Digestive; 🇫🇷 Paris, Ile de France, France

Hôpital Lariboisière - Service de Chirurgie Digestive; 🇫🇷 Paris, Ile de France, France