Early Temporary Stoma Closure After Proctectomy

Status Completed

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Ileostomy

Clinical Trial Details

NCT number	NCT00428636
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Completed
Phase	N/A
Start date	May 2001
Completion date	July 2005

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01514136` - An Investigation of Ostomy Devices	N/A
Completed	`NCT00738283` - Zinc and Copper Absorption in Neonates With Bilious Losses	N/A
Terminated	`NCT04372992` - The Stoma Closure Before or After Adjuvant Therapy Trial	N/A
Completed	`NCT02594085` - An Exploratory Study Investigating Adhesive Reaction to Output	N/A
Completed	`NCT02543190` - System-Wide Improvement for Transitions After Surgery: The SWIFT Post op Program	N/A
Terminated	`NCT01782196` - A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy	N/A
Completed	`NCT02610907` - A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put	N/A
Completed	`NCT02626260` - A Pilot Evaluation of Adhesives and How They Are Impacted by Output	N/A
Completed	`NCT03909542` - Malnutrition Associated With Complications After Ileostomy Reversal
Recruiting	`NCT02499588` - User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™	N/A
Completed	`NCT01939106` - One Piece Drainable Pouch in Subjects With an Ileostomy	Phase 2
Completed	`NCT00128804` - The STOVITA Study - Bioefficacy of Beta-Carotene in Oil and in a Mixed Diet in Ileostomy Patients	N/A
Completed	`NCT02675634` - Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy	N/A
Terminated	`NCT02042677` - Assessment of a Skin Barrier	N/A
Completed	`NCT05915052` - B-suture Ileostomy in Clinical Practice: a Retrospective, Single-center, Propensity Score-matched Study	N/A
Completed	`NCT02362360` - Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy	N/A
Completed	`NCT02351817` - An Explorative Randomized Controlled Investigation Evaluating Newly Developed Ostomy Products	N/A
Completed	`NCT02351791` - An Exploratory Study Investigating Human Skin Reaction to Output	N/A
Recruiting	`NCT05457660` - Transverse Study About QOL for Colostomized or Ileostomized Patients During Their Home Hospitalization
Completed	`NCT02036346` - Electrolyte Profile, Nutritional Status and Ileostomy Formation.	N/A