Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome

Low Anterior Resection Syndrome Clinical Trial

— TAILARS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758195
• Other study ID #: E2021004
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Qiyuan Qin, M.D.
• Phone: 86-20-38254052
• Email: qinqy3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Low Anterior Resection Syndrome
• Syndrome

Intervention

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.

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

Locations

Country	Name	City	State
China	Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anorectal function impairment	Anorectal function will be assessed by anorectal manometry.	at the time of 6 months since the start of treatment
Primary	Number of participants with major low anterior resection syndrome score (LARS score)		at the time of 6 months since the start of treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	Fecal continence impairment	Fecal incontinence will be assessed by Wexner incontinence scale.	at the time of 6, 12 months since the start of treatment