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| Sponsored by: |
University of Heidelberg |
| Information provided by: | University of Heidelberg |
| ClinicalTrials.gov Identifier: | NCT00457327 |
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 |
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Rectal Cancer |
Procedure: protective ileostomy |
Phase II |
| MedlinePlus related topics: | Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer |
| 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) |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |||||
| Clinical Study Center Surgery, Department of Surgery, University of Heidelberg | |||||
| Heidelberg, Germany, 69120 | |||||
| University of Heidelberg |
| 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
Department of Surgery, University of Heidelberg
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Study Center of the German Surgical Society
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| Responsible Party: | Department of General, Visceral and Transplantation Surgery ( University of Heidelberg ) |
| Study ID Numbers: | 433/2005 |
| First Received: | April 4, 2007 |
| Last Updated: | June 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00457327 |
| Health Authority: | Germany: Ethics Commission |
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