Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-06-30

Brief Summary

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Bowel dysfunction after rectal cancer resection comprises a vast array of bowel symptoms and associated quality-of-life impairment, collectively termed as low anterior resection syndrome (LARS). There are 40%-60% patients who suffer from major LARS after sphincter-preserving surgery. No consensus exists for LARS treatment or prevention. Transanal irrigation (TAI) was reported to play a helpful role in the management of major LARS and fecal incontinence. However, the preventive effect and daily accessibility need further confirmation. In this randomized trial, TAI compared with best support treatment, is used in patients who received curative low anterior resection for rectal cancer with diverting stoma, after completion of the stoma reversal. The primary outcome is the occurrence of major LARS after 6 months of the treatment.

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Detailed Description

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Conditions

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Low Anterior Resection Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Transanal irrigation

Transanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months.

Group Type EXPERIMENTAL

Transanal irrigation

Intervention Type PROCEDURE

Transanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months.

Best supportive therapy

Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.

Group Type ACTIVE_COMPARATOR

Best supportive therapy

Intervention Type OTHER

Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.

Interventions

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Transanal irrigation

Transanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months.

Intervention Type PROCEDURE

Best supportive therapy

Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age: 18-75 years old
* Curative low anterior resection for rectal cancer with diverting stoma
* Stoma closure within 1 month
* Preoperative radiotherapy or height of anastomosis less than 5 cm from anal verge
* No evidence of anastomotic leakage or severe stenosis

Exclusion Criteria

* Tumor recurrence or distant metastasis
* Secondary operation with stoma
* Prior disease impairing bowel function except for rectal cancer
* Any contraindication for transanal irrigation
* Pregnant or nursing
* Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease
* Cognitive or psychological disorder

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No