Clinical trial NCT05007015: Transanal Irrigation for the Management of LARS
Official title: Transanal Irrigation for the Management of Low Anterior Resection Syndrome (LARS): a Multicenter Crossover Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Anterior Resection Syndrome
Rectal Cancer
Keywords: Transanal irrigations
Quality of Life
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: CHU de Quebec-Universite Laval
First posted: 2021-08-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multicenter randomized controlled crossover trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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 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.

Primary outcomes:
measure: EORTC-QLQ-C30
timeFrame: Monthly for the seven months of the trial
Secondary outcomes:
measure: LARS Score
timeFrame: Monthly for the seven months of the trial
measure: Satisfaction Survey
timeFrame: Monthly for the seven months of the trial
measure: Bowel diaries
timeFrame: Will be taken in first and last 2 week periods of each treatment groups
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References:
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