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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00956241

Enrollment

127

Registered

2009-08-11

Start date

2002-04-30

Completion date

2007-01-31

Last updated

2009-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

rectal cancer, colonic pouch, side-to-end anastomosis, preoperative radiotherapy

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.

Interventions

PROCEDUREj-pouch coloanal anastomosis

PROCEDUREside-to-end coloanal anastomosis

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026