Back to resultsJ-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer
Primary Purpose
Rectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
j-pouch coloanal anastomosis
side-to-end coloanal anastomosis
Sponsored by
About this trial
This is an interventional treatment trial for Rectal Cancer focused on measuring rectal cancer, colonic pouch, side-to-end anastomosis, preoperative radiotherapy
Eligibility Criteria
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.
Sites / Locations
- Academic Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
j-pouch coloanal anastomosis
side-to-end coloanal anastomosis
Arm Description
although a j-pouch coloanal anastomosis is a common type of anastomosis, a comparison with the side-to-end has not been made.
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
Outcomes
Primary Outcome Measures
Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months.
Secondary Outcome Measures
Function of the neo-rectum as assessed by the functional outcome questionnaire
Surgical results
Quality of life
Full Information
NCT ID
NCT00956241
First Posted
August 10, 2009
Last Updated
August 10, 2009
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Dutch Digestive Diseases Foundation, Commission of Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek: CKTO).
1. Study Identification
Unique Protocol Identification Number
NCT00956241
Brief Title
J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer
Official Title
J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer: a Multicenter Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Dutch Digestive Diseases Foundation, Commission of Applied Clinical Research (Commissie voor Klinisch Toegepast Onderzoek: CKTO).
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
rectal cancer, colonic pouch, side-to-end anastomosis, preoperative radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
j-pouch coloanal anastomosis
Arm Type
Other
Arm Description
although a j-pouch coloanal anastomosis is a common type of anastomosis, a comparison with the side-to-end has not been made.
Arm Title
side-to-end coloanal anastomosis
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
j-pouch coloanal anastomosis
Intervention Type
Procedure
Intervention Name(s)
side-to-end coloanal anastomosis
Primary Outcome Measure Information:
Title
Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Function of the neo-rectum as assessed by the functional outcome questionnaire
Time Frame
12 months
Title
Surgical results
Time Frame
4 and 12 months
Title
Quality of life
Time Frame
4 and 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
21831100
Citation
Doeksen A, Bakx R, Vincent A, van Tets WF, Sprangers MA, Gerhards MF, Bemelman WA, van Lanschot JJ. J-pouch vs side-to-end coloanal anastomosis after preoperative radiotherapy and total mesorectal excision for rectal cancer: a multicentre randomized trial. Colorectal Dis. 2012 Jun;14(6):705-13. doi: 10.1111/j.1463-1318.2011.02725.x.
Results Reference
derived
Learn more about this trial
J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer
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