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Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer

Phase 2
18 Years
Not Enrolling
Rectal Cancer

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Trial Information

Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer

Since introduction of total mesorectal excision prognosis and quality of life of patients
with rectal cancer of the middle or lower third of the rectum could be improved
significantly. There is no valid data about the need of protective ileostomy in these
patients. About 10% of the patients develop insufficiency of the anastomosis and might
benefit from ileostomy whereas about 90% would not have required protective ileostomy
retrospectively. Aim of the study is to show that protective ileostomy is not required if
several criteria are fulfilled and early measures in case of clinical impairment are
defined. Therefore eligibility criteria include safely performed stapler anastomosis with
complete rings and control of impermeability by air insufflation. In the event of clinical
impairment in the postoperative course CT scan with KM filling of the rectum to exclude
insufficiency of the anastomosis will be performed. In case of insufficiency protective
ileostomy will be created. 40 patients will be included.

Comparison: Patients with resectable rectal cancer of the middle or lower third will be
intraoperatively randomized to either protective ileostomy or no ileostomy at all.

Inclusion Criteria:

- radical resectable rectal cancer

- low sphincter-preserving resection of carcinomas of the lower and middle third

- preoperative normal continence

- preoperative normal sphincter function

- complete rings after stapler anastomosis

- impermeability of anastomosis for air

- written informed consent

Exclusion Criteria:

- reduced cooperation or drug abuse

- pregnancy

- psychosis

- age under 18 years

Type of Study:


Study Design:

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

Outcome Measure:

Morbidity and mortality until day 30 postoperative

Principal Investigator

Markus W Buchler, Chairman

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, University of Heidelberg, Medical School


Germany: Ethics Commission

Study ID:




Start Date:

July 2006

Completion Date:

March 2007

Related Keywords:

  • Rectal Cancer
  • protective ileostomy
  • rectal cancer
  • low anterior resection
  • Rectal Neoplasms