Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome (TAILARS)

Sun Yat-sen University

Status: Enrolling

Conditions: Low Anterior Resection Syndrome

Treatments: Other: Best supportive therapy; Procedure: Transanal irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT04758195

E2021004

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Transanal irrigation

Experimental group

Description:

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.

Treatment:

Procedure: Transanal irrigation

Best supportive therapy

Active Comparator group

Description:

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

Treatment:

Other: Best supportive therapy