Clinical trial · Interventional
Transanal Irrigation for the Management of LARS
Transanal Irrigation for the Management of Low Anterior Resection Syndrome (LARS): A Multicenter Crossover 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)
This study aims to evaluate the impact of Transanal irrigation (TAI) on the quality of life and low anterior resection symptoms (LARS) in Canadian rectal cancer survivors living with minor to major LARS. It proposes to teach TAI through a novel online platform and to provide virtual nursing support for the participants. To our knowledge, this is the first North American based and largest randomized control trial on the use of TAI for patients with LARS. This will also be the first study to teach and support patients through the TAI process using a virtual platform. While TAI has been demonstrated to reduce LARS scores and increased QoL in patients with significant LARS, its feasibility and acceptance for Canadian patients remains uncertain. Furthermore despite the existing studies, the rate of TAI seems to be low in North America. The hypothesis is that TAI, taught and supported through an online portal dedicated to LARS patients, will positively impact QoL and improve LARS symptoms. The results of this trial may allow TAI to become part of the standard armamentarium that clinicians offer patients for LARS management, with the presence of online nursing support and guidance to facilitate this practice.
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 |
|---|---|---|---|
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transanal Irrigation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transanal Irrigation
- description
- This group will be instructed on the use of TAI to be perform daily for the three month duration of their treatment arm
- interventionNames
- Procedure: Transanal Irrigation
- type
- NO_INTERVENTION
- label
- Tradition care Control arm
- description
- This group tradition care group will have no modification to the care they have received prior to commencing the study. The patients in this group will use the usual dietary modifications and medications prescribed by the treating team to manage their LARS. No changes will be made to the treatment regime prescribed by their surgeon.
Primary outcomes (1)
- measure
- EORTC-QLQ-C30
- timeFrame
- Monthly for the seven months of the trial
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Low anterior resection by a laparoscopic, robotic, transanal total mesorectal excision, or open approach with (or without) creation of a diverting loop ileostomy for the treatment of rectal cancer, advanced adenoma or dysplasia And * have had their ileostomy closed (if applicable) And * completed treatment at least 6 months ago (including ileostomy closure) And * LARS score \> 20 points Exclusion Criteria: * Inability to provide informed consent, including insufficient fluency in English or French. * Inability to access the internet. * Presence of an ostomy at the time of study enrollment. * Active or ongoing treatment for rectal disease. * Anastomotic stricture, sinus, or any other ongoing anastomotic complication. * Current use of TAI under the direction of a clinical team.
References
Publications (17)
- BACKGROUNDKeane C, Fearnhead NS, Bordeianou LG, Christensen P, Basany EE, Laurberg S, Mellgren A, Messick C, Orangio GR, Verjee A, Wing K, Bissett I; LARS International Collaborative Group. International Consensus Definition of Low Anterior Resection Syndrome. Dis Colon Rectum. 2020 Mar;63(3):274-284. doi: 10.1097/DCR.0000000000001583. PMID 32032141
- BACKGROUNDBryant CL, Lunniss PJ, Knowles CH, Thaha MA, Chan CL. Anterior resection syndrome. Lancet Oncol. 2012 Sep;13(9):e403-8. doi: 10.1016/S1470-2045(12)70236-X. PMID 22935240
- BACKGROUNDFayers P, Bottomley A; EORTC Quality of Life Group; Quality of Life Unit. Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer. Eur J Cancer. 2002 Mar;38 Suppl 4:S125-33. doi: 10.1016/s0959-8049(01)00448-8. PMID 11858978
- BACKGROUNDKim MJ, Park JW, Lee MA, Lim HK, Kwon YH, Ryoo SB, Park KJ, Jeong SY. Two dominant patterns of low anterior resection syndrome and their effects on patients' quality of life. Sci Rep. 2021 Feb 11;11(1):3538. doi: 10.1038/s41598-021-82149-9. PMID 33574345
- BACKGROUNDEkkarat P, Boonpipattanapong T, Tantiphlachiva K, Sangkhathat S. Factors determining low anterior resection syndrome after rectal cancer resection: A study in Thai patients. Asian J Surg. 2016 Oct;39(4):225-31. doi: 10.1016/j.asjsur.2015.07.003. Epub 2015 Sep 2. PMID 26340884
- BACKGROUNDBattersby NJ, Juul T, Christensen P, Janjua AZ, Branagan G, Emmertsen KJ, Norton C, Hughes R, Laurberg S, Moran BJ; United Kingdom Low Anterior Resection Syndrome Study Group. Predicting the Risk of Bowel-Related Quality-of-Life Impairment After Restorative Resection for Rectal Cancer: A Multicenter Cross-Sectional Study. Dis Colon Rectum. 2016 Apr;59(4):270-80. doi: 10.1097/DCR.0000000000000552. PMID 26953985
- Sturiale A, Martellucci J, Zurli L, Vaccaro C, Brusciano L, Limongelli P, Docimo L, Valeri A. Long-term functional follow-up after anterior rectal resection for cancer. Int J Colorectal Dis. 2017 Jan;32(1):83-88. doi: 10.1007/s00384-016-2659-6. Epub 2016 Sep 30.