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

Phase 2

Terminated

• Conditions: Rectal Cancer

• Registration Number: NCT00457327
• Lead Sponsor: Heidelberg University

Brief Summary

The purpose of this study is to determine whether protective ileostomy is required after low anterior resection due to rectal cancer

Detailed Description

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.

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2007-04-04
• Study First Submitted QC: 2007-04-04
• Study First Posted: 2007-04-06
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-04
• Last Update Posted: 2008-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Morbidity and mortality until day 30 postoperative

Secondary Outcome Measures

Name	Time	Method
Quality of life
Ranking of factors influencing quality of life

Trial Locations

Locations (1)

Clinical Study Center Surgery, Department of Surgery, University of Heidelberg; 🇩🇪 Heidelberg, Germany