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.