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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00457327
• Other study ID #: 433/2005
• Status: Terminated
• Phase: Phase 2
• First received: April 4, 2007
• Last updated: June 4, 2008
• Start date: July 2006
• Est. completion date: March 2007

Study information

• Verified date: June 2008
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• protective ileostomy

Locations

Country	Name	City	State
Germany	Clinical Study Center Surgery, Department of Surgery, University of Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morbidity and mortality until day 30 postoperative
Secondary	Quality of life
Secondary	Ranking of factors influencing quality of life

External Links

•   Department of Surgery, University of Heidelberg
•   Study Center of the German Surgical Society