NCT00428636

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2007

Completed
Last Updated

January 30, 2007

Status Verified

January 1, 2007

First QC Date

January 26, 2007

Last Update Submit

January 26, 2007

Conditions

Ileostomy

Keywords

ileostomyrectal resectionproctectomystoma closure

Outcome Measures

Primary Outcomes (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 Outcomes (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)

Interventions

ileostomyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital AMBROISE PARE - Service de Chirurgie Digestive

Boulogne-Billancourt, Île-de-France Region, 92100, France

Location

Hôpital Cochin - Service de Chirurgie Digestive

Paris, Île-de-France Region, 75014, France

Location

Hôpital Lariboisière - Service de Chirurgie Digestive

Paris, Île-de-France Region, 75475, France

Location

Related Publications (1)

  • 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.

    PMID: 18446781DERIVED

MeSH Terms

Interventions

Ileostomy

Intervention Hierarchy (Ancestors)

EnterostomyDigestive System Surgical ProceduresSurgical Procedures, OperativeOstomy

Study Officials

  • Yves Panis, Professor

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2007

First Posted

January 30, 2007

Study Start

May 1, 2001

Study Completion

July 1, 2005

Last Updated

January 30, 2007

Record last verified: 2007-01

Locations

FR(3)