Low Anterior Resection Syndrome
Conditions
Keywords
Low Anterior Resection Syndrome, Transanal irrigation, Rectal cancer, Prevention
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.
Interventions
PROCEDURETransanal 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.
OTHERBest supportive therapy
Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Anorectal function impairment | at the time of 6 months since the start of treatment | Anorectal function will be assessed by anorectal manometry. |
Countries
China
Contacts
Primary ContactQiyuan Qin, M.D.
Outcome results
None listed