Low Anterior Resection SyndromeTAI-LARSNCT05007015
Transanal Irrigation for the Management of LARS
A study testing Transanal Irrigation in people with Low Anterior Resection Syndrome and Rectal Cancer, run by Jewish General Hospital at 8 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome, Rectal Cancer
- What is being tested?
- Transanal Irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 8 sitesCanada
- Study dates
- 15 Jan 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Health Science North
Greater Sudbury, Ontario, P3E 5J1
London Health Science Centre
London, Ontario, N6A 5W9
Jewish General Hospital
Montreal, Quebec, H3T 1E2
McGill University Health Centre
Montreal, Quebec
Centre de Recherche du CHU de Québec - Hôpital Saint-François d'Assise
Québec, Quebec, G1L 3L5
University Health Network
Toronto, Ontario, M5G 2C4
Providence Hospital - St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
University of British Columbia - Island Health Colorectal Surgery
Victoria, British Columbia, V8R 6R5
About this study
Official title: Transanal Irrigation for the Management of Low Anterior Resection Syndrome (LARS): A Multicenter Crossover Randomized Controlled Trial
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.
Read the detailed description
Low anterior resection syndrome (LARS) is a constellation of bowel symptoms which occur following rectal cancer treatment. These symptoms have a well characterized negative impact on a patient's quality of life (QoL) following sphincter sparing surgery. The treatment of LARS is primarily based on the management of symptoms with conservative measures such as dietary changes and fiber supplements, anti-diarrheal medications and pelvic floor physiotherapy. Despite these measures, patients often still experience uncontrolled debilitating symptoms.
Transanal irrigation (TAI) has been described for the management of LARS symptoms that persist after conservative measures have been insufficient. The positive impact of this treatment on LARS and the number of bowel movements experienced by patients has been demonstrated in several, primarily European small studies. This multicenter, assessor-blinded, parallel-group randomized control trial (RCT) will assess the outcomes of an online, nurse-led, North American TAI program for the management of LARS.
This RCT will recruit patients who have undergone a low anterior resection (LAR) with closure of any diverting stoma at least 6 months prior to entry into the trial with a LARS score of >20 at recruitment. Participants will be recruited from five academic hospitals with high volumes of rectal cancer care in Ontario and Quebec, and will be randomized using a computer-generated sequence in balanced blocks, stratified by hospital, to the intervention (TAI) or control (traditional care) arms.
Participants in the intervention arm will be asked to perform TAI every 1-2 days for a six-month period. Teaching on the use of TAI will be given through virtual sessions with an experienced research nurse and supportive material (video and animated text) on a web-based application, eLARS. This is an established online application designed to provide quality health information for patients living with LARS created by our research group. Participants in the intervention arm of this study will be given access to a restricted transanal irrigation section on this application dedicated to this RCT with detailed written instructions and educational videos on the use of TAI. Participants in the control arm of the study will have access to the general eLARS application without the section on the transanal irrigation, and no specific change in their current management routine will be required. The required sample size for this RCT, accounting for attrition, is 99 patients. It is anticipated this patient sample can be accrued from the five interested sites within a year.
The primary outcome of the study will be health-related quality of life (QoL) as measured by the European Organization for Research and Treatment of Cancer core Quality of Life questionnaire (EORTIC-QLQ-C30), with secondary outcomes including evaluation of bowel function by the LARS score, Wexner/Cleveland Clinic Fecal Incontinence Score, and bowel diary and satisfaction with TAI. Participant demographics, disease and treatment characteristics will be obtained via hospital chart review as time of recruitment. The TAI treatment effect on global QoL will be modeled using generalized estimating equations (GEE), accounting for within-subject correlations between responses at different time-points, and possible clustering of responses among participants from the same hospital.
To our knowledge, this will be the first North American trial to assess TAI acceptance and impact on quality of life for patients living with LARS. Furthermore, this will be the largest RCT to date, and the first to use a virtual platform to deliver this service for rectal cancer survivors. This study aims to provide an additional feasible and acceptable treatment option for the management of LARS symptoms refractory to our currently limited treatment options.
- Conditions
- Low Anterior Resection Syndrome, Rectal Cancer
- Being tested
- Transanal Irrigation
- Keywords
- Transanal irrigations, Quality of Life
- Medical subject headings
- Low Anterior Resection Syndrome, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal IrrigationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Monthly for the seven months of the trial
Secondary outcomes (3)
LARS Score
Bowel function over the course of treatment. Scores range from 0 to 42 0-20: No LARS 21-29: Minor LARS 30-42: Major LARS
Measured: Baseline, 3-month, 5-month, and 7-month
Satisfaction Survey
Satisfaction survey based on LARS Consensus Definition symptoms and consequences
Measured: Baseline, 3-month, and 7-month
Cleveland Clinic Fecal Incontinence Score (CCFIS)
Fecal incontinence over the course of the treatment as recorded in the Cleveland Clinic Fecal Incontinence Score (CCFIS)
Measured: Baseline, 3-month, 5-month, 7-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start15 Jan 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multicenter randomized controlled crossover trial
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Dr. Marylise Boutros, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007015
- Sponsor's protocol ID
- MP-05-2022-2925
- Acronym
- TAI-LARS
- Status last verified
- May 2026
- First submitted
- 10 Aug 2021
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32032141Bryant 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.
PubMed 22935240Fayers 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.
PubMed 11858978Kim 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.
PubMed 33574345Ekkarat 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.
PubMed 26340884Battersby 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.
PubMed 26953985Sturiale 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.
PubMed 27695976Iwama 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.
PubMed 2724726McCutchan 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.
PubMed 29226518Rosen 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.
PubMed 21689359Koch 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.
PubMed 19452159Martellucci 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.
PubMed 30083782Enriquez-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.
PubMed 31585495Gosselink 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.
PubMed 15606588Rosen 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.
PubMed 31388638
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transanal Irrigation for the Management of Low Anterior Resection Syndrome (LARS): A Multicenter Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05007015
- Acronym / sponsor ID
- TAI-LARS / MP-05-2022-2925
- Conditions
- Low Anterior Resection Syndrome, Rectal Cancer
- Keywords
- Transanal irrigations, Quality of Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Low anterior resection syndrome (LARS) is a constellation of bowel symptoms which occur following rectal cancer treatment. These symptoms have a well characterized negative impact on a patient's quality of life (QoL) following sphincter sparing surgery. The treatment of LARS is primarily based on the management of symptoms with conservative measures such as dietary changes and fiber supplements, anti-diarrheal medications and pelvic floor physiotherapy. Despite these measures, patients often still experience uncontrolled debilitating symptoms.
Transanal irrigation (TAI) has been described for the management of LARS symptoms that persist after conservative measures have been insufficient. The positive impact of this treatment on LARS and the number of bowel movements experienced by patients has been demonstrated in several, primarily European small studies. This multicenter, assessor-blinded, parallel-group randomized control trial (RCT) will assess the outcomes of an online, nurse-led, North American TAI program for the management of LARS.
This RCT will recruit patients who have undergone a low anterior resection (LAR) with closure of any diverting stoma at least 6 months prior to entry into the trial with a LARS score of >20 at recruitment. Participants will be recruited from five academic hospitals with high volumes of rectal cancer care in Ontario and Quebec, and will be randomized using a computer-generated sequence in balanced blocks, stratified by hospital, to the intervention (TAI) or control (traditional care) arms.
Participants in the intervention arm will be asked to perform TAI every 1-2 days for a six-month period. Teaching on the use of TAI will be given through virtual sessions with an experienced research nurse and supportive material (video and animated text) on a web-based application, eLARS. This is an established online application designed to provide quality health information for patients living with LARS created by our research group. Participants in the intervention arm of this study will be given access to a restricted transanal irrigation section on this application dedicated to this RCT with detailed written instructions and educational videos on the use of TAI. Participants in the control arm of the study will have access to the general eLARS application without the section on the transanal irrigation, and no specific change in their current management routine will be required. The required sample size for this RCT, accounting for attrition, is 99 patients. It is anticipated this patient sample can be accrued from the five interested sites within a year.
The primary outcome of the study will be health-related quality of life (QoL) as measured by the European Organization for Research and Treatment of Cancer core Quality of Life questionnaire (EORTIC-QLQ-C30), with secondary outcomes including evaluation of bowel function by the LARS score, Wexner/Cleveland Clinic Fecal Incontinence Score, and bowel diary and satisfaction with TAI. Participant demographics, disease and treatment characteristics will be obtained via hospital chart review as time of recruitment. The TAI treatment effect on global QoL will be modeled using generalized estimating equations (GEE), accounting for within-subject correlations between responses at different time-points, and possible clustering of responses among participants from the same hospital.
To our knowledge, this will be the first North American trial to assess TAI acceptance and impact on quality of life for patients living with LARS. Furthermore, this will be the largest RCT to date, and the first to use a virtual platform to deliver this service for rectal cancer survivors. This study aims to provide an additional feasible and acceptable treatment option for the management of LARS symptoms refractory to our currently limited treatment options.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter randomized controlled crossover trial
| Arm | Type | Receives |
|---|---|---|
| Transanal Irrigation | Experimental | Procedure: Transanal IrrigationThis group will be instructed on the use of TAI to be perform daily for the three month duration of their treatment arm |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transanal IrrigationEach 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. | Procedure or surgery | Transanal Irrigation |
Primary outcome
EORTC-QLQ-C30
Time frame: Monthly for the seven months of the trial
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)
3 secondary outcomes
LARS Score
Time frame: Baseline, 3-month, 5-month, and 7-month
Satisfaction Survey
Time frame: Baseline, 3-month, and 7-month
Cleveland Clinic Fecal Incontinence Score (CCFIS)
Time frame: Baseline, 3-month, 5-month, 7-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 32032141Keane 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.
- Background: PubMed 22935240Bryant 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.
- Background: PubMed 11858978Fayers 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.
- Background: PubMed 33574345Kim 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.
- Background: PubMed 26340884Ekkarat 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.
- Background: PubMed 26953985Battersby 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.
- Background: PubMed 27695976Sturiale 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.
- Background: PubMed 2724726Iwama 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.
- Background: PubMed 29226518McCutchan 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.
- Background: PubMed 21689359Rosen 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.
- Background: PubMed 19452159Koch 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.
- Background: PubMed 30083782Martellucci 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal Irrigation in people with Low Anterior Resection Syndrome and Rectal Cancer, run by Jewish General Hospital at 8 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC-QLQ-C30 (time frame: Monthly for the seven months of the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05007015, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.