Clinical trial · Interventional
Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome
A Prospective, Randomized, Open, Parallel Trial of Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome in Rectal Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best supportive therapy | Other | — | UNRESOLVED |
| Transanal irrigation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transanal irrigation
- description
- 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.
- interventionNames
- Procedure: Transanal irrigation
- type
- ACTIVE_COMPARATOR
- label
- Best supportive therapy
- description
- Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.
- interventionNames
- Other: Best supportive therapy
Primary outcomes (1)
- measure
- Number of participants with major low anterior resection syndrome score (LARS score)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available