J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer
1 other identifier
interventional
127
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 10, 2009
CompletedFirst Posted
Study publicly available on registry
August 11, 2009
CompletedAugust 11, 2009
August 1, 2009
4.8 years
August 10, 2009
August 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months.
4 months
Secondary Outcomes (3)
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
Study Arms (2)
j-pouch coloanal anastomosis
OTHERalthough a j-pouch coloanal anastomosis is a common type of anastomosis, a comparison with the side-to-end has not been made.
side-to-end coloanal anastomosis
OTHERin 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
Interventions
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic Medical Center
Amsterdam, 1105 AZ, Netherlands
Related Publications (1)
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.
PMID: 21831100DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 10, 2009
First Posted
August 11, 2009
Study Start
April 1, 2002
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
August 11, 2009
Record last verified: 2009-08