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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00457327
Recruitment Status : Terminated (RCT with same hypothesis ended and showed a superiority for protective ileostomy after lower anterior rectum resection.)
First Posted : April 6, 2007
Last Update Posted : June 5, 2008
Information provided by:
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

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: protective ileostomy Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2006
Primary Completion Date : March 2007
Study Completion Date : March 2007

Primary Outcome Measures :
  1. Morbidity and mortality until day 30 postoperative

Secondary Outcome Measures :
  1. Quality of life
  2. Ranking of factors influencing quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00457327

Clinical Study Center Surgery, Department of Surgery, University of Heidelberg
Heidelberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Heidelberg, Department of General, Visceral and Transplantation Surgery Identifier: NCT00457327     History of Changes
Other Study ID Numbers: 433/2005
First Posted: April 6, 2007    Key Record Dates
Last Update Posted: June 5, 2008
Last Verified: June 2008

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
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases