Early Closure of Temporary 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

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-12-31

Brief Summary

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The study is being conducted as a prospective randomized controlled multicenter study of patients with a temporary ileostomy due to rectal cancer. The study will be conducted in hospitals in Denmark and Sweden under the framework of the Scandinavian Surgical Outcomes Group (www.ssorg.net).

The study investigates the effect of reversing a temporary ileostomy after 8-13 days instead of later reversal more than 12 weeks after surgery.

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Detailed Description

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After creation of the temporary ileostomy patients are included and are randomized to two groups. Patients in the intervention group will have the stoma closed 8-13 days after stoma creation and will be compared to patients in the control group where the stoma is closed after a minimum of 12 weeks (standard treatment in Denmark and Sweden).

Before randomization the eligible patients undergo a CT of the rectum to visualise the anastomosis and possible leakage. Furthermore, the local investigators may choose to supplement the CT with a rectoscopy.

The research group includes 89 patients over an expected period of 4 years. Both groups are examined for postoperative complications as well as stoma-related complications at discharge and 3, 6 and 12 months after stoma creation.

The research group also examines the impact on patients´ health-related quality of life at 3, 6 and 12 months after stoma creation.

Finally the socio-economic effect in both groups will be analyzed and compared 6 and 12 months after stoma creation.

An interim analysis is planned for safety as well as recalculation of statistical power.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early reversal group

Early reversal of temporary ileostomy

Group Type EXPERIMENTAL

Early reversal of temporary ileostomy

Intervention Type PROCEDURE

Temporary ileostomy is reversed 8-13 days after the primary surgery

Control group

Standard reversal of temporary ileostomy

Group Type ACTIVE_COMPARATOR

Standard reversal of temporary ileostomy

Intervention Type PROCEDURE

Patients in the control group will have the ileostomy reversed according to standard treatment, which is 12-26 weeks after primary operation

Interventions

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Early reversal of temporary ileostomy

Temporary ileostomy is reversed 8-13 days after the primary surgery

Intervention Type PROCEDURE

Standard reversal of temporary ileostomy

Patients in the control group will have the ileostomy reversed according to standard treatment, which is 12-26 weeks after primary operation

Intervention Type PROCEDURE

Other Intervention Names

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stoma reversal 8-13 days post surgery stoma reversal 12-26 weeks after stoma creation

Eligibility Criteria

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Inclusion Criteria

* Patients with a temporary ileostomy after low anterior resection because of rectal cancer
* Patients, who are physically and mentally fit to undergo surgery within 8-13 days

Exclusion Criteria

* Patients whose stoma is not reversible
* Patients with diabetes
* Patients being treated with Steroids
* Patients with communicative problems
* Patients with expected compliance issues

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No