Early Temporary Stoma Closure After Proctectomy

• ClinicalTrials.gov Identifier: NCT00428636
• Recruitment Status: Completed
• First Posted: January 30, 2007
• Last Update Posted: January 30, 2007
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by: Assistance Publique - Hôpitaux de Paris

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ileostomy	Procedure: ileostomy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 270 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study of Early Closure of Temporary Loop Ileostomy After Elective Rectal Resection With Low Pelvic Anastomoses
• Study Start Date: May 2001
• Study Completion Date: July 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

France

Hôpital AMBROISE PARE - Service de Chirurgie Digestive

Billancourt, Ile de France, France, 92100

Hôpital Cochin - Service de Chirurgie Digestive

Paris, Ile de France, France, 75014

Hôpital Lariboisière - Service de Chirurgie Digestive

Paris, Ile de France, France, 75475

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

• Study Director: Yves Panis, Professor; Assistance Publique - Hôpitaux de Paris

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. doi: 10.1002/bjs.6212.

• ClinicalTrials.gov Identifier: NCT00428636
• Other Study ID Numbers: AOM 00154
• First Posted: January 30, 2007
• Last Update Posted: January 30, 2007
• Last Verified: January 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:

ileostomy; rectal resection; proctectomy; stoma closure