Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Low Anterior Resection Syndrome

Intervention / Treatment
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* Procedure: Transanal irrigation
* Other: Best supportive therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transanal irrigation<br>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<br>* 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.<br>|
| Active Comparator: Best supportive therapy<br>Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication. | Other: Best supportive therapy<br>* Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer, Low Anterior Resection Syndrome, Transanal irrigation, Prevention