Clinical trial · Interventional
J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer
J-pouch Versus Side-to-end Coloanal Anastomosis After Preoperative Radiotherapy and Total Mesorectal Excision for Rectal Cancer: a Multicenter Randomized Trial
NCT00956241CI-TRIAL-00002537completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| j-pouch coloanal anastomosis | Procedure | — | UNRESOLVED |
| side-to-end coloanal anastomosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- j-pouch coloanal anastomosis
- description
- although a j-pouch coloanal anastomosis is a common type of anastomosis, a comparison with the side-to-end has not been made.
- interventionNames
- Procedure: j-pouch coloanal anastomosis
- type
- OTHER
- label
- side-to-end coloanal anastomosis
- 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
- interventionNames
- Procedure: side-to-end coloanal anastomosis
Primary outcomes (1)
- measure
- Primary endpoint was the function of the neo-rectum as assessed by a validated functional outcome questionnaire at 4 months.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDDoeksen 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 21831100