Early Temporary Stoma Closure After Proctectomy

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00428636
First received: January 26, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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 Intervention
Ileostomy
Procedure: ileostomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Early Closure of Temporary Loop Ileostomy After Elective Rectal Resection With Low Pelvic Anastomoses

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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:
  • 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)

Estimated Enrollment: 270
Study Start Date: May 2001
Estimated Study Completion Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00428636

Locations
France
Hôpital AMBROISE PARE - Service de Chirurgie Digestive
Billancourt, Ile de France, France, 92100
Hôpital Lariboisière - Service de Chirurgie Digestive
Paris, Ile de France, France, 75475
Hôpital Cochin - Service de Chirurgie Digestive
Paris, Ile de France, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Director: Yves Panis, Professor Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00428636     History of Changes
Other Study ID Numbers: AOM 00154
Study First Received: January 26, 2007
Last Updated: January 26, 2007
Health Authority: France: Institutional Ethical Committee

Keywords provided by Assistance Publique - Hôpitaux de Paris:
ileostomy
rectal resection
proctectomy
stoma closure

ClinicalTrials.gov processed this record on July 28, 2014