Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome

Not Applicable

Recruiting

• Conditions: Low Anterior Resection Syndrome
• Interventions: Other: Best supportive therapy; Procedure: Transanal irrigation

• Registration Number: NCT04758195
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-17
• Study Start: 2021-03-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Best supportive therapy	Best supportive therapy	Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.
Transanal irrigation	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with major low anterior resection syndrome score (LARS score)	at the time of 6 months since the start of treatment

Secondary Outcome Measures

Name	Time	Method
Number of participants with major low anterior resection syndrome score (LARS score)	at the time of 1, 3, 12 months since the start of treatment
Bowel function impairment	at the time of 6, 12 months since the start of treatment	Bowel function will be assessed by Memorial Sloan Kettering Cancer Centre Bowel Function Instrument (MSKCC BFI). Stool frequency will be recorded in the day and night.
Fecal continence impairment	at the time of 6, 12 months since the start of treatment	Fecal incontinence will be assessed by Wexner incontinence scale.
Quality of life impairment assessed by Short Form 36 (SF-36)	at the time of 6, 12 months since the start of treatment	Quality of life will be assessed by Short Form 36 (SF-36) health questionnaire.

Trial Locations

Locations (1)

Sixth Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China