Symptoms and General Pathology

All Conditions

Digestive System Diseases

Syndrome

Low Anterior Resection Syndrome

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Colonic Diseases

Postoperative Complications

Gastrointestinal Agents

All Drugs and Chemicals

Loperamide

Sorbitol

Antidiarrheals

Laxatives

Cathartics

Manual transanal irrigation to control bowel function.

Effect of Transanal irrigation (TAI) using Peristeen® anal irrigation system - Coloplast

Transanal irrigation

Medication to help control of the bowel movement (One or a combination of Loperamide, Sorbitol, Sterculia gum)

Medication

Mirna Abraham-Nordling, MD.PhD

A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer. The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.

A randomized controlled trial (RCT) in patients who underwent sphincter preserving surgery due to rectal cancer.

The study will analyze the effect of Transanal irrigation (TAI) and medication that can help control of the bowel movement in patients with low anterior resection syndrome.

An interim analysis will be made after 40 included patients in the study.

Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery

A Randomized Controlled Study of the Effect of Treatment of Low Anterior Resection Syndrome (LARS) After Rectal Cancer Surgery

Assessed using LARS questionnaire (score 0-42, a high score indicates poor bowel function)

Assessed using EORTC Quality of life questionnaire (QLQ)-C30

Mirna Abraham-Nordling

MD. PhD. Associate Professor of Surgery

Glycerol

Protective Agents

Participants receiving TAI will irrigate once/day with stepwise volumes; 1. month 150 ml, 2. month 300 ml, and 3. month 500 ml.

Participants treated with glycerol suppositories will administer one glycerol suppository once/day.

The system works by connecting a tube from a water bag to a cone. The cone is placed into the rectum and the prescribed water volume is pumped into the rectum. When the water has been installed the valve is closed and the cone removed. Residual water and stool will then flow into the toilet.

Qufora Irrisedo Cone System

Rectal suppository. Stimulates the rectum and softens and loosens stool.

Glycerol "OBA"

Mira Mekhael, M.D.

Peter Christensen, Professor

Mira Mekhael, MD

Peter Christensen

The study is a multicentre randomized controlled trial with the objective to compare the effect of transanal irrigation with glycerol suppositories in patients suffering from major Low Anterior Resection Syndrome (LARS).

Transanal irrigation (TAI) is used as a second-line treatment following unsuccessful personalised conservative treatment (PCT) of LARS. However, it is unknown if scheduled, initiated defecation with the aid of a glycerol suppository will have the same clinical effect as TAI. Thus, the aim of this study is to compare the effect of TAI with a glycerol suppository in patients suffering from major LARS.

The study is a multi-centre, randomised, controlled, 12 weeks, parallel-group trial comparing treatment with TAI to treatment with glycerol suppositories. Patients will be randomised - stratified by centre and neoadjuvant radiotherapy - in a 1:1 ratio to receive treatment with TAI or glycerol suppositories. Primary endpoint will be assessed by the end of week twelve.

Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome

Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome: A Multicentre Randomised Controlled Trial

MYMOP2 is a validated problem-specific, patient-generated questionnaire. Patients are asked to specify one or two symptoms that concern them the most. Subsequently they evaluate the severity on a 7-point Likert scale. The second part of the questionnaire uses the same scale to assess whether the symptom limits or prevent any daily activity, and also to rate general well-being. Follow-up questionnaires address the original issues completed in the initial form. Symptom 1, symptom 2, activity, and wellbeing each have a separate score between 0 and 6 with 0 indicating "as good as it could be" and 6 "as bad as it could be". An overall score is calculated by taking the average of item scores.

The LARS score is a validated questionnaire for evaluation of bowel function after sphincter-preserving surgery. It covers five LARS symptoms including: incontinence for flatus, incontinence for liquid stools, frequency (number of daily bowel movements), clustering, and urgency. The scores from each five answers are added to one final score. The score ranges from 0-42 with 0 indicating the best score and 42 the worst. Based on the score patients are stratified into: 0-20: No LARS, 21-29: Minor LARS, 30-42: Major LARS.

The MSKCC BFI score is a validated questionnaire for evaluation of bowel function after sphincter-preserving surgery. It comprises 18 items covering the frequency of various LARS symptoms and is divided into three sub-scales and four single items. It is scored on a 5-point Likert scale ranging from "always" to "never". The sub-scales scores are summarised as: A 6-item frequency sub-scale (6-30), a four-item dietary sub-scale (4-20), and a four-item urgency sub-scale (4-20). A global score can be calculated as the sum of the sub-scale scores. A total score (possible score range 18-90) can be calculated by adding all the item scores (sub-scale scores plus single item scores). A higher score indicates better bowel function.

Journl A/S has developed an application for evaluation of bowel function. The participants can enter real-time data into the application and data will be stored in a backend allowing calculations of frequencies and averages on these parameters during weeks 3-4, 6-8, and 11-12 in the study period.

The St. Mark's Incontinence score is a validated questionnaire for evaluation of fecal incontinence. It covers the frequency of three types of fecal incontinence: Solid, liquid, and gas and the consequences: Pad wearing or usage of a plug, and lifestyle alteration. Furthermore, it incorporates: urgency and the need for antidiarrheal drugs. For each item of fecal incontinence and lifestyle alterations the frequency option ranges from never (score 0) to daily (score 4). The rest of the items are scored as follows: Urgency: No (score 0) or yes (score 4), antidiarrheal drugs: No (score 0) or yes (score 2), pad wearing: No (score 0) or yes (score 2). The total score is the sum of each item. The minimum score is 0 = no incontinence and maximum score is 24 = totally incontinent.

The ICIQ-FLUTS questionnaire is validated for evaluating female lower urinary tract symptoms. It consists of 12 items which are all scores from 0-4 and the overall score ranges from 0-48. A higher score indicates a worse condition. A filling sub-scale (0-16), a voiding sub-scale (0-12), and an incontinence symptoms sub-scale can be calculated (0-20).

The ICIQ-MLUTS questionnaire is validated for evaluating male lower urinary tract symptoms. It consists of 13 items which are all scores from 0-4 and the overall score ranges from 0-52. A higher score indicates a worse condition. A voiding sub-scale (0-20) and an incontinence symptoms sub-scale (0-24) can be calculated.

The Rectal Cancer Female Sexuality Score is a validated questionnaire for assessment of sexuality after treatment for rectal cancer. The score includes 7 items and ranges from 0-29. A score \>= 9 indicates sexual dysfunction.

The 5-item International Index of Erectile Function (IIEF-5) Questionnaire is a 5-question validated questionnaire for assessment of erectile dysfunction (ED). The possible scores range from 5-25 and the severity of ED is classified into five categories stratified by score: 22-25 (no ED), 17-21 (mild), 12-16 (mild to moderate), 8-11(moderate), 5-7 (severe).

The European Organisation for Research and Treatment of Cancer (EORTC) developed and validated a 30-item core questionnaire (QLQ-C30) reflecting global QoL in cancer patients. QLQ-C30 comprises five functional scales, three symptom scales, a global health scale/ a quality of life scale, and six single items. All the scales and single item measures range in score from 0-100. A high score represents a higher level of functioning, a high quality of life, and a greater degree of symptoms.

QLQ-CR29 is developed by The European Organisation for Research and Treatment of Cancer (EORTC). It is a validated supplement to the QLQ-C30 specifically designed for assessment of quality of life in colorectal cancer patients. QLQ-CR29 consists of four functional scales and eighteen single items. All the scales range from 0-100. A high score represents a higher level of functioning and a greater degree of symptoms.

Journl A/S has developed an application for evaluation of bowel function and impact on quality of life and activity. The participants can enter real-time data into the application and data will be stored in a backend allowing daily evaluation of quality of life and activity during weeks 3-4, 6-8, and 11-12 in the study period.

The EQ-5D-5L is a standardised measure of health status developed by the EuroQoL Group. It consists of a descriptive system and a EQ Visual Analogue scale. Each dimension in the descriptive system has five levels: No problems, slight problems, moderate problems, severe problems, and extreme problems. Each dimension is referred to in terms of a 5-digit code. The EQ Visual Analogue scale records the respondent's self-rated health on a vertical scale ranging from 0-100 where the endpoints are labelled "best imaginable" (100) and "worst imaginable" (0). The EQ-5D-5L can be converted into an index value which facilitates the calculation of quality-adjusted life years (QALYs) that are used in economic evaluations of health care interventions.

The ICECAP-5 is a validated questionnaire for measure of capability for the general adult population for use in economic evaluation. It covers: attachment, stability, achievement, enjoyment, and autonomy. Each item is scored from 1-4 with 4 indicating the best capability and 1 the worst. A total score can be calculated ranging from 5-20. Furthermore, a weighted score can be calculated.

University of Aarhus

Rare Diseases

Oculocerebral Syndrome With Hypopigmentation

patients randomised to start with PNE stimulation over 4 weeks. Then the stimulator will be removed and after a wash out period of 4 weeks they will be trained in transanal irrigation

Patients randomised to start with transanal irrigation treatment in 8 weeks, thereafter a wash out period of 4 weeks before being implanted with a neuro stimulator

Implantation of a nerve stimulator to stimulate the sacral nerve plexus

Percutaneous nerve evaluation

Katrine J. Emmertsen, MD

A randomised trial testing the effect of percutaneous nerve evaluation and transanal irrigation on bowel function in patients after low anterior resection for rectal cancer.

Patients will undergo anal physiological assessment and will then be randomized to either treatment arm. The first 12 weeks they will be optimized in the conservative treatment of their bowel function before beginning active treatment with TAI or PNE. After 8 and 4 weeks respectively, the treatment will stop and they will have a period of 4 weeks back on optimized conservative treatment before beginning active treatment in the other active arm.

Detailed records of bowel, micturition and sexual function and QoL will be obtained at regular intervals during the entire trial fase.

Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation

Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation. A Randomized Cross Over Study.

A symptom score ranging from 0 to 42 points calculated on the basis of bowel function

self-reported sexual function measured by validated questionnaires

self-reported bladder function by validated questionnaires

faecal incontinence measured by wexner score and St. Marks incontinence score

Behaviors and Mental Disorders

Quality of Life

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

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.

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

Sarah Sabboobeh

Jessica Holland, MD

Marylise Boutros, MD, MSc, FRCSC, FACS. FABCRS

Sender Liberman

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.

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.

Multicenter randomized controlled crossover trial

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

Transanal Irrigation for the Management of LARS

Transanal Irrigation for the Management of Low Anterior Resection Syndrome (LARS): A Multicenter Crossover Randomized Controlled 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)

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

Satisfaction survey based on LARS Consensus Definition symptoms and consequences

Standardize measure of the number of bowel movement per day

McGill University Health Centre/Research Institute of the McGill University Health Centre

CHU de Quebec-Universite Laval

Jewish General Hospital

Assistant Professor of Surgery, McGill University

This group will be instructed on High-volume TAI to be perform daily or every 2 days for 2 months. After 15 days of wash-out they will switch to Low-TAI treatment for 2 months.

This group will be instructed on Low-volume TAI to be perform daily or every 2 days for 2 months. After 15 days of wash-out they will switch to the Low-TAI treatment for 2 months.

The High-TAI (400-1000ml) will be self-performed using the Peristeen® Transanal irrigation system with the conic catheter every 48 hours during the first two week of treatment. Then patients could change frequency and volume of TAI depending on their needs and/or preference.

The Low-TAI will be self-performed using a standard 250ml water enema every 48 hours during the first two week of treatment. Then patients could change frequency of TAI depending on their needs and/or preference.

Peristeen® Transanal irrigation system with the conic catheter

Standard reusable enema

Loris Trenti, PhD

Alba Aramburu

Loris Trenti, MD

The aim of this study is to investigate whether the high-volume transanal irrigation (TAI) performed by the Peristeen Plus® system is superior to the low-volume TAI performed by standard 250ml water enema for the treatment of Low Anterior Resection Syndrome (LARS).

Most of the patients operated on for rectal cancer present defecatory disfunction symptoms known as Low Anterior Resection Syndrome (LARS) of different degree and severity. Although, transanal irrigation (TAI) has been shown to be useful in improve LARS and quality of life of these patients no evidence exists about the best way to realize TAI in terms of irrigation volume and systems and frequency of irrigation. This crossover randomized controlled trial aims to evaluate the impact of two different type of TAI (high-volume by Peristeen Plus® and low-volume performed by 250ml water enema) on LARS and quality of life in patients with major LARS secondary to low anterior rectal resection (LAR) for primary rectal cancer. The primary outcome is the reduction of LARS score after two months of treatment.

Transanal Irrigation for Low Anterior Resection Syndrome.

High-volume and Low-volume Water Transanal Irrigation for the Management of Low Anterior Resection Syndrome. A Crossover Randomized Controlled Clinical Trial.

LARS score changes with treatments.

No LARS: 0-20; Minor LARS 21-29; Major LARS 30-42.

Quality of life changes with treatments.

Values between 0-100 (higher score means better outcome).

Fecal incontinence symptoms change with treatments.

Values between 0-24 (higher score means worse outcome).

Patients' satisfaction grade related with treatments

What treatment is preferred by the patients after having tried both

Adverse effects and complication directly related with one of the two treatments.

Asociacion Española de Coloproctologia

Asociación Española de Cirugía

Hospital Universitari de Bellvitge

Principal Investigator

Herbal and Botanical

Cola

Patients who have undergone colonic resection for colorectal cancer in the last 10 years. Patient reported outcome measures collected at 3-monthly intervals.

Cohort participants who are identified as having 'major LARS' at any point are treated with Optimised Conservative Managements, consisting of medication, dietary advice, lifestyle advice and physiotherapy.

Cohort participants who are identified as having 'major LARS' at any point are treated with Trans-anal irrigation, in additional to receiving optimised conservative management. Transanal irrigation system will be decided upon with the participant and procured locally.

Cohort participants who are identified as having 'major LARS' at any point are treated with Sacral Neuromodulation system, in addition to receiving optimised conservative management. Medtronic Interstim system will be used.

Sacral Neuromodulation group will include up-to 20 patients with major LARS. Medtronic Interstim system will be used, including 2 week trial device.

Sacral NeuroModulation

Trans-Anal irrigation group will include up-to 20 patients with major LARS. Specific system will be agreed with the patient, depending on eligibility and preference.

Trans-Anal Irrigation

Optimised conservative management will include up-to 30 patients with major LARS. They will be provided with a resource booklet which includes dietary and lifestyle advice as well as exercises that can be undertaken independently.

Optimised Conservative Management

Julie A Cornish

Currently, no standard exists for the treatment and management of Low Anterior Resection Syndrome (LARS)- a common disorder that affects patients who have had part of their bowel removed due to colorectal cancer. Decisions about which treatment patients receive is at the discretion of local clinicians, leading to a variation in both clinical practice and the outcomes of these patients. As a result, there is a need for research to assess what treatments are most effective in treating or managing LARS to establish a consensus and develop a treatment pathway in the UK. This study aims to assess the feasibility of undertaking such a trial utilising a novel 'trial within cohorts (TWiCs)' study design, with a view to informing the design of a full-scale trial.

Rectal cancer (cancer of the lower part of the bowel) is one of the most prevalent forms of cancer, and affects approximately 14,000 people each year in the UK. The treatment for the majority of these patients is surgical removal of the affected part of the bowel, following which the bowel is joined back together. Some patients may also require chemotherapy and radiotherapy. One consequence of the treatment of bowel cancer is a severe form of bowel dysfunction called major Low Anterior Resection Syndrome (LARS).

LARS is a constellation of symptoms including incontinence to stool, urgency and frequency of bowel movements and incomplete evacuation; it is diagnosed using the LARS scoring tool. Major LARS can have a huge impact on the persons quality of life resulting in social isolation. Currently there are no guidelines for the management of LARS. The aim of the POLARiS study is to investigate three different treatments for major LARS; optimised conservative management, a combination of diet, medication, bowel retraining and pelvic floor exercises; transanal irrigation, washing out the back passage of stool with warmed water; and sacral nerve stimulation where an electrical impulse delivered to the sacral nerve to help with bowel function. This feasibility study aims to test the study design ahead of a larger fully powered randomised control trial. The study will firstly recruit any consenting adult who has had surgery for rectal cancer (called an anterior resection) and who does not have a stoma, into a cohort and then follow up those patients every 3 months with bowel function and quality of life assessments. Any patient found to have major LARS (LARS score over 30) will be invited into the randomised control trial where the above three treatments will be tested.

Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study

A Feasibility, Multicentre Randomised Control Trial Assessing the Treatment Options for Patient With Major Low Anterior Resection Syndrome to Establish a Pathway Of Low Anterior Resection Syndrome Relief After Surgery

The total number of participants enrolled into the study over the recruitment period.

We will record basic demographics, medical history and prevalence of relative symptoms of participants enrolled in the cohort study to describe the characteristics of no- minor- and major- LARS patients

The number of participants in the cohort that meet the criteria for 'major low anterior resection syndrome (LARS)', as measured by the LARS scoring tool. LARS scoring tool produces a score from 0 - 42, which represents the severity of symptoms, where 0 is least severe and 42 is most severe. Score =\>30 is considered 'major LARS'. LARS score will be measured at 5 times at 3-monthly intervals over 12 months.

The time (in months) from resection surgery to onset of 'major LARS' symptoms, as reported by the LARS scoring tool.

The time (in months) from completing radiotherapy treatment to onset of 'major LARS' symptoms, as reported by the LARS scoring tool.

The total number of cohort participants that are enrolled into the randomised trial part of the study, over the recruitment period.

The proportion of randomised participants that meet the criteria for, and are allocated to, each of the three trial arms (transanal irrigation; sacral neuromodulation; optimised conservative management).

Where possible, we will record patient's previous treatments and interactions with health services in relation to their bowel dysfunction symptoms. This will be used to describe the variation in UK clinical practice in terms of diagnosis, management and treatment pathways.

The proportion of participants that complete and return follow-up questionnaires (four questionnaires at 3-month intervals).

The proportion of patients that continue to receive the treatment assigned to them at the end of the follow-up period.

LARS score will be measured at 5 time points (at 3-monthly intervals from baseline to 12 months) to assess severity of bowel dysfunction. Self-reported by participants using the LARS scoring tool (min 0, max 42) where higher score denotes greater severity of symptoms.

Patient-reported quality of life will be measured using the EuroQuol 5-Dimension Health-related Quality of Life instrument (5-level) (EQ-5D-5L) at 5 time-points (3-monthly intervals from baseline to 12 months). Quality of life total score will be calculated (min 5; max 25), where reduction in total score represents improvement in quality of life.

Quality of life will be self-reported by participants using the European Organisation for Research and Treatment of Cancer Colorectal Quality of Life Questionnaire (EORTC QLQ-CR29) at 5 time-points (3-monthly intervals, from baseline to 12 months). Quality of life total score will be calculated (min 26; max 104) where reduction in total score represents improvement in quality of life.

Quality of life will be self-reported by participants using the European Organisation for Research and Treatment of Cancer Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This will be recorded at 5 time-points (3-monthly intervals, from baseline to 12 months). Total score will be calculated (min 30; max 128), where reduction in total score represents improvement in quality of life.

Measure Yourself Medical Outcome Profile (MYMOP) 2 will be used to record patient-reported medical outcome profile at 5 time-points (3-montly intervals from baseline to 12 months). Change in patient-reported severity (min 0; max 5) will be measured, where change ≥ 1.0 is considered clinically significant.

We will record any adverse events reported by randomised patients in relation to each of the treatments they receive, which impairs their adherence to the study protocol, treatment programme or safety.

Treatments offered to manage individual patient's LARS symptoms will be recorded, along with duration of treatment and reasons for stopping. This will be used to support the description of standard care variation and patient characteristics.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery	NCT03215017	Low Anterior Re...	Transanal irrig... Medication	18 Years -	Karolinska Institutet
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome	NCT04087421	Low Anterior Re... Rectal Cancer	Qufora Irrisedo... Glycerol "OBA"	18 Years -	University of Aarhus
Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation	NCT01313026	Rectal Cancer	Percutaneous ne...	18 Years -	University of Aarhus
Transanal Irrigation for the Management of LARS	NCT05007015	Low Anterior Re... Rectal Cancer	Transanal Irrig...	18 Years -	Jewish General Hospital
Transanal Irrigation for Low Anterior Resection Syndrome.	NCT05245331	Low Anterior Re...	Peristeen® Tran... Standard reusab...	18 Years -	Hospital Universitari de Bellvitge
Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome	NCT04087421	Low Anterior Re... Rectal Cancer	Qufora Irrisedo... Glycerol "OBA"	18 Years -	University of Aarhus
Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study	NCT05319054	Low Anterior Re...	Sacral NeuroMod... Trans-Anal Irri... Optimised Conse...	18 Years -	Cardiff and Vale University Health Board

Spots Global Cancer Trial Database for transanal irrigation