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Early Closure of Temporary Ileostomy- a Randomized Clinical Trial

18 Years
Open (Enrolling)
Rectal Cancer

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Trial Information

Early Closure of Temporary Ileostomy- a Randomized Clinical Trial

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 200 patients over an expected period of 1 year. Both groups are
examined for postoperative complications at discharge and 3, 6 and 12 months after stoma

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.

Inclusion Criteria:

- Patients with a temporary ileostomy after low anterior resection because of rectal

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Postsurgical morbidity

Outcome Description:

Patients are scored according to the Clavien-Dindo Classification of Surgical Complications.

Outcome Time Frame:

3 months after inclusion

Safety Issue:


Principal Investigator

Jacob Rosenberg, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Herlev Hospital, University of Copenhagen


Denmark: Danish Dataprotection Agency

Study ID:




Start Date:

February 2011

Completion Date:

August 2014

Related Keywords:

  • Rectal Cancer
  • Rectal cancer
  • Temporary ileostomy
  • Ealy reversal
  • Morbidity
  • Mortality
  • Quality of life
  • Economic effect
  • Rectal Neoplasms