Clinical trial · Interventional
Transanal Irrigation for Low Anterior Resection Syndrome.
High-volume and Low-volume Water Transanal Irrigation for the Management of Low Anterior Resection Syndrome. A Crossover Randomized Controlled Clinical Trial.
NCT05245331CI-TRIAL-00095229HiLoV_TAIactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of this study is to investigate whether the high-volume transanal irrigation (TAI) performed by the Peristeen Plus® system is superior to the low-volume TAI performed by standard 250ml water enema for the treatment of Low Anterior Resection Syndrome (LARS).
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 |
|---|---|---|---|
| Peristeen® Transanal irrigation system with the conic catheter | Device | — | UNRESOLVED |
| Standard reusable enema | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- High-volume TAI
- description
- This group will be instructed on High-volume TAI to be perform daily or every 2 days for 2 months. After 15 days of wash-out they will switch to Low-TAI treatment for 2 months.
- interventionNames
- Device: Peristeen® Transanal irrigation system with the conic catheter
- Device: Standard reusable enema
- type
- ACTIVE_COMPARATOR
- label
- Low volume - TAI
- description
- This group will be instructed on Low-volume TAI to be perform daily or every 2 days for 2 months. After 15 days of wash-out they will switch to the Low-TAI treatment for 2 months.
- interventionNames
- Device: Peristeen® Transanal irrigation system with the conic catheter
- Device: Standard reusable enema
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Personal history of LAR or ultra-LAR with total mesorectal excision (TME) and sphincter preservation with stapled or manual end to end anastomosis for primary rectal cancer. * Major LARS (score 30-42). * At least 1 year follow-up after LAR or ultra-LAR or temporary stoma closure. * Anastomotic integrity demonstrated by endoscopic, radiologic or clinical examination. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0-2. * Age≥ 18 years Exclusion Criteria: * Side to end mechanical anastomosis or J-pouch colorectal anastomosis * Partial or total intersphincteric resection. * Personal history of anastomotic dehiscence, chronic pelvic sepsis, anastomotic sinus, anastomotic stricture or other any other anastomotic complications. * Persona history of other colorectal, proctologic or pelvis surgery or disease. * Personal history of bariatric surgery. * Functioning sacral neurostimulator carriers. * Previous use of transanal irrigation systems for LARS treatment * Presence of an ostomy. * Local or distant rectal cancer recurrence and/or any other active neoplastic disease. * Altered cognitive status. * Pregnancy and age \< 18 years * Any other diseases that may alter results of the study. * Refusal to sign the informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.