Transanal Irrigation for the Management of LARS

NCT05007015 | Active Not Recruiting

• 1 other identifier: MP-05-2022-2925
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

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

Low Anterior Resection Syndrome; Rectal Cancer

Keywords

Transanal irrigations; Quality of Life

Outcome Measures

Primary Outcomes (1)

• EORTC-QLQ-C30

  Quality of Life change with treatment. Scale scores are calculated by averaging items within scales and transforming average scores linearly. All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems. For more details, are available in the EORTC QLQ-C30 Scoring Manual (Fayers et al., 2001)

  Monthly for the seven months of the trial

Secondary Outcomes (3)

• LARS Score

  Monthly for the seven months of the trial

• Satisfaction Survey

  Monthly for the seven months of the trial

• Bowel diaries

  Will be taken in first and last 2 week periods of each treatment groups

Study Arms (2)

Transanal Irrigation

EXPERIMENTAL

This group will be instructed on the use of TAI to be perform daily for the three month duration of their treatment arm

Procedure: Transanal Irrigation

Tradition care Control arm

NO INTERVENTION

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.

Interventions

Transanal Irrigation PROCEDURE

Each participant will receive a mailed package of TAI materials, given access to the LARS website, and have two scheduled virtual visits with a trained research nurse to learn how to use TAI once assigned to the intervention arm. These sessions will include one on one session with the nurse for review of the material, discussion of the device and any questions. TAI involves introducing an applicator into the anus for irrigation. An initial volume of 1000 mL will be suggested but can be increased to 1500 mL or reduced to 500 mL as per patient preference and tolerance. Applicators are single-use instruments that can be disposed of into standard waster receptacle after each treatment. The irrigation system is multiple-use and can be used for the duration recommend by the manufacturer manual. Daily irrigation can take anywhere between 20 and 90 minutes depending on individual patient experience.

Transanal Irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to provide informed consent, including fluency in English or French language
• unable to access the internet,
• presence of an ostomy,
• no active or ongoing treatment
• anastomotic stricture, sinus or any other ongoing anastomotic complications.

Sponsors & Collaborators

• Jewish General Hospital: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• CHU de Quebec-Universite Laval: collaborator

Study Sites (2)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Related Publications (16)

• Keane 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 BACKGROUND

• Bryant 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 BACKGROUND

• Fayers 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 BACKGROUND

• Kim 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 BACKGROUND

• Ekkarat 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 BACKGROUND

• Battersby 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 BACKGROUND

• 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.

  PMID: 27695976 BACKGROUND

• Iwama T, Imajo M, Yaegashi K, Mishima Y. Self washout method for defecational complaints following low anterior rectal resection. Jpn J Surg. 1989 Mar;19(2):251-3. doi: 10.1007/BF02471596.

  PMID: 2724726 BACKGROUND

• McCutchan GM, Hughes D, Davies Z, Torkington J, Morris C, Cornish JA; LARRIS Trial Management Group. Acceptability and benefit of rectal irrigation in patients with Low Anterior Resection Syndrome: a qualitative study. Colorectal Dis. 2017 Dec 11. doi: 10.1111/codi.13985. Online ahead of print.

  PMID: 29226518 BACKGROUND

• Rosen H, Robert-Yap J, Tentschert G, Lechner M, Roche B. Transanal irrigation improves quality of life in patients with low anterior resection syndrome. Colorectal Dis. 2011 Oct;13(10):e335-8. doi: 10.1111/j.1463-1318.2011.02692.x.

  PMID: 21689359 BACKGROUND

• Koch SM, Rietveld MP, Govaert B, van Gemert WG, Baeten CG. Retrograde colonic irrigation for faecal incontinence after low anterior resection. Int J Colorectal Dis. 2009 Sep;24(9):1019-22. doi: 10.1007/s00384-009-0719-x. Epub 2009 May 19.

  PMID: 19452159 BACKGROUND

• Martellucci J, Sturiale A, Bergamini C, Boni L, Cianchi F, Coratti A, Valeri A. Role of transanal irrigation in the treatment of anterior resection syndrome. Tech Coloproctol. 2018 Jul;22(7):519-527. doi: 10.1007/s10151-018-1829-7. Epub 2018 Aug 6.

  PMID: 30083782 BACKGROUND

• Enriquez-Navascues JM, Labaka-Arteaga I, Aguirre-Allende I, Artola-Etxeberria M, Saralegui-Ansorena Y, Elorza-Echaniz G, Borda-Arrizabalaga N, Placer-Galan C. A randomized trial comparing transanal irrigation and percutaneous tibial nerve stimulation in the management of low anterior resection syndrome. Colorectal Dis. 2020 Mar;22(3):303-309. doi: 10.1111/codi.14870. Epub 2019 Oct 21.

  PMID: 31585495 BACKGROUND

• Gosselink MP, Darby M, Zimmerman DD, Smits AA, van Kessel I, Hop WC, Briel JW, Schouten WR. Long-term follow-up of retrograde colonic irrigation for defaecation disturbances. Colorectal Dis. 2005 Jan;7(1):65-9. doi: 10.1111/j.1463-1318.2004.00696.x.

  PMID: 15606588 BACKGROUND

• Rosen HR, Kneist W, Furst A, Kramer G, Hebenstreit J, Schiemer JF. Randomized clinical trial of prophylactic transanal irrigation versus supportive therapy to prevent symptoms of low anterior resection syndrome after rectal resection. BJS Open. 2019 Mar 18;3(4):461-465. doi: 10.1002/bjs5.50160. eCollection 2019 Aug.

  PMID: 31388638 BACKGROUND

• Rodrigues BDS, Rodrigues FP, Buzatti KCLR, Campanati RG, Profeta da Luz MM, Gomes da Silva R, Lacerda-Filho A. Feasibility Study of Transanal Irrigation Using a Colostomy Irrigation System in Patients With Low Anterior Resection Syndrome. Dis Colon Rectum. 2022 Mar 1;65(3):413-420. doi: 10.1097/DCR.0000000000002005.

  PMID: 33872283 BACKGROUND

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Allocation with be generated by a centralized computer generated randomized sequence to ensure allocation concealment. Data analyst will be blinding to treatment group but no other masking is feasible given the treatment
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery, McGill University

Model Details: Multicenter randomized controlled crossover trial

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 16, 2021
• Study Start: January 15, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 29, 2025

Record last verified: 2025-07

Locations

CA (2)