Clinical trial · Interventional
Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS): A Pilot Randomized Controlled Trial
- 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)
Transanal irrigation (TAI) has shown to improve fecal incontinence and increase quality of life in patients with low anterior resection syndrome (LARS). This trial is a small study being conducted to determine whether a larger trial is feasible. Investigators are also doing this research to see if TAI impacts quality of life and improves bowel function within the early post-operative period (1-12 months). This treatment is designed for participants to have more control over their bowel movements and reduce the dependency on immediate access to the toilet.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LARS mobile application | Other | — | UNRESOLVED |
| Peristeen Plus Irrigation kit | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Transanal Irrigation (TAI) - intervention arm
- description
- Participants in the TAI-intervention arm will receive TAI (using Peristeen Plus Irrigation kit), training of TAI administration, and access to the LARS app (including TAI module).
- interventionNames
- Device: Peristeen Plus Irrigation kit
- Other: LARS mobile application
- type
- OTHER
- label
- Continued conservative management - control arm.
- description
- Participants in the control arm will receive conservative management and access to the LARS app (excluding the TAI module). Conservative management includes individualized combinations of dietary modifications, pharmacologic therapies, pelvic floor rehabilitation, and structured follow-up
- interventionNames
- Other: LARS mobile application
Primary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adults (≥18 years-old) patients who underwent a LAR for any indication via open, laparoscopic, robotic, or transanal total mesorectal excision, with creation of a diverting loop ileostomy, 2. have confirmed anastomotic healing demonstrated by flexible sigmoidoscopy and CT scan with rectally-administered water soluble contrast or gastrograffin enema, 3. are planned for an ileostomy closure operation, and 4. are in the first 12 months post-LAR operation Exclusion Criteria: 1. Inability to comprehend English or Spanish or provide informed consent (Note: after the English documents are approved, the study team plans to obtain a Spanish consent and study documents), 2. ongoing chemotherapy or radiotherapy, and 3. ongoing anastomotic complication.
References
Publications (0)
Data not yet available