Early Versus Late Closure of Preventive Ileostomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-01

Study Completion Date

2018-12-30

Brief Summary

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The study is designed and performed as a prospective randomized controlled single-center study. Patients who underwent rectal resection with preventive ileostomy due to rectal cancer will be included. The study investigates the effect of reversing a temporary ileostomy after 30 vs 90 days.

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Detailed Description

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Conditions

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Ileostomy, Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Early closure of preventive ileostomy

A preventive ileostomy is closed 30 days after the primary surgery

Group Type EXPERIMENTAL

Deileostomy

Intervention Type PROCEDURE

Deileostomy

Late closure of preventive ileostomy

A preventive ileostomy is closed 90 days after the primary surgery

Group Type EXPERIMENTAL

Deileostomy

Intervention Type PROCEDURE

Deileostomy

Interventions

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Deileostomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with temporary ileostomy after rectal resection for rectal cancer
* Patients willing to participate in the study

Exclusion Criteria

* Anastomosis insufficiency detected clinically or radiologically.
* Patients, who are physically and mentally unfit to undergo surgery or to be followed-up

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No