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

A Prospective, Randomized, Open, Parallel Trial of Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome in Rectal Cancer Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Low Anterior Resection Syndrome
• Intervention / Treatment: Procedure: Transanal irrigation; Other: Best supportive therapy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiyuan Qin, M.D.; Phone Number: 86-20-38254052; Email: qinqy3@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sixth Affiliated Hospital, Sun Yat-sen University
      • Contact: Qiyuan Qin, M.D.; Phone Number: 86-20-38254052; Email: qinqy3@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Active Comparator: Best supportive therapy; Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.	Other: Best supportive therapy; Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Quality of life impairment assessed by Short Form 36 (SF-36)	Quality of life will be assessed by Short Form 36 (SF-36) health questionnaire.	at the time of 6, 12 months since the start of treatment
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	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.	at the time of 6, 12 months since the start of treatment
Fecal continence impairment	Fecal incontinence will be assessed by Wexner incontinence scale.	at the time of 6, 12 months since the start of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anorectal function impairment	Anorectal function will be assessed by anorectal manometry.	at the time of 6 months since the start of treatment

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Investigators: Principal Investigator: Qiyuan Qin, M.D., The Sixth Affiliated hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 16, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Rectal cancer; Prevention; Transanal irrigation; Low Anterior Resection Syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Syndrome; Low Anterior Resection Syndrome
• Other Study ID Numbers: E2021004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No