Early Closure of Temporary Ileostomy (EASY)

Herlev Hospital

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: Early reversal of temporary ileostomy; Procedure: Standard reversal of temporary ileostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01287637

AKD03

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

Early reversal group

Experimental group

Description:

Early reversal of temporary ileostomy

Treatment:

Procedure: Early reversal of temporary ileostomy

Control group

Active Comparator group

Description:

Standard reversal of temporary ileostomy

Treatment:

Procedure: Standard reversal of temporary ileostomy