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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
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 consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGNumber of participants with major low anterior resection syndrome score (LARS score)
Time frame: at the time of 6 months since the start of treatment
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.
Time frame: at the time of 6, 12 months since the start of treatment
Number of participants with major low anterior resection syndrome score (LARS score)
Time frame: 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.
Time frame: at the time of 6, 12 months since the start of treatment
Fecal continence impairment
Fecal incontinence will be assessed by Wexner incontinence scale.
Time frame: at the time of 6, 12 months since the start of treatment
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