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

This study has been terminated.
(RCT with same hypothesis ended and showed a superiority for protective ileostomy after lower anterior rectum resection.)
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00457327
First received: April 4, 2007
Last updated: June 4, 2008
Last verified: June 2008
  Purpose

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


Condition Intervention Phase
Rectal Cancer
Procedure: protective ileostomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Morbidity and mortality until day 30 postoperative

Secondary Outcome Measures:
  • Quality of life
  • Ranking of factors influencing quality of life

Estimated Enrollment: 40
Study Start Date: July 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457327

Locations
Germany
Clinical Study Center Surgery, Department of Surgery, University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Markus W Buchler, Chairman Department of Surgery, University of Heidelberg, Medical School
Study Chair: Peter Kienle, Consultant Department of Surgery, University of Heidelberg
  More Information

Additional Information:
No publications provided by Heidelberg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Heidelberg, Department of General, Visceral and Transplantation Surgery
ClinicalTrials.gov Identifier: NCT00457327     History of Changes
Other Study ID Numbers: 433/2005
Study First Received: April 4, 2007
Last Updated: June 4, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Heidelberg University:
protective ileostomy
rectal cancer
low anterior resection

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014