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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2007-01-31

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.

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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.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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j-pouch coloanal anastomosis

although a j-pouch coloanal anastomosis is a common type of anastomosis, a comparison with the side-to-end has not been made.

Group Type OTHER

j-pouch coloanal anastomosis

Intervention Type PROCEDURE

side-to-end coloanal anastomosis

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

Group Type OTHER

side-to-end coloanal anastomosis

Intervention Type PROCEDURE

Interventions

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j-pouch coloanal anastomosis

Intervention Type PROCEDURE

side-to-end coloanal anastomosis

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No