J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer: a Multicenter Randomized Trial

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: j-pouch coloanal anastomosis
* Procedure: side-to-end coloanal anastomosis


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: j-pouch coloanal anastomosis<br>although a j-pouch coloanal anastomosis is a common type of anastomosis, a comparison with the side-to-end has not been made. | Procedure: j-pouch coloanal anastomosis<br> <br> |
| Other: side-to-end coloanal anastomosis<br>in the Netherlands, the side-to-end anastomosis is the standard procedure to perform an anastomosis in case of rectal resection. therefore, the side-to-end group was our control group | Procedure: side-to-end coloanal anastomosis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer, colonic pouch, side-to-end anastomosis, preoperative radiotherapy