Status:
COMPLETED
J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Dutch Digestive Diseases Foundation
Commission of Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek: CKTO).
Conditions:
Rectal Cancer
Eligibility:
All Genders
Phase:
NA
Brief Summary
The objective of this study was to compare the functional and surgical results of the J-pouch with those of the side-to-end anastomosis and their impact on quality of life.
Detailed Description
Invalidating anorectal dysfunctions are common after restorative rectal surgery. Improvement of functional results by the technically more demanding J-pouch has been demonstrated in comparison with th...
Eligibility Criteria
Inclusion
- The inclusion criteria comprised a histologically proven rectal cancer located in the middle or distal part of the rectum (≤ 10cm from the anal verge), and a WHO performance status ≤ 2.
Exclusion
- Patients with a T1 or T4 tumor were excluded
- Patients diagnosed with distant metastases
- A medical history of colonic resection
- Anorectal surgery or chemo- radiotherapy
- Pre-existing fecal incontinence grade III or IV according to Parks10
- Life expectancy of less than one year.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00956241
Start Date
April 1 2002
End Date
January 1 2007
Last Update
August 11 2009
Active Locations (1)
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1
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ