J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer
Not Applicable
Completed
- Conditions
- Rectal Cancer
- Registration Number
- NCT00956241
- 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 the straight coloanal anastomosis. In the present multicenter randomized trial we assessed whether the J-pouch is also superior to the side-to-end coloanal anastomosis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 127
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months. 4 months
- Secondary Outcome Measures
Name Time Method Function of the neo-rectum as assessed by the functional outcome questionnaire 12 months Surgical results 4 and 12 months Quality of life 4 and 12 months
Trial Locations
- Locations (1)
Academic Medical Center
🇳🇱Amsterdam, Netherlands
Academic Medical Center🇳🇱Amsterdam, Netherlands