Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05319054
Study type Interventional
Source Cardiff and Vale University Health Board
Contact
Status Active, not recruiting
Phase N/A
Start date May 23, 2022
Completion date September 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04087421 - Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome Phase 3
Recruiting NCT03828318 - Impact of a Patient-Centered Program for Low Anterior Resection Syndrome A Multicenter Randomized Controlled Trial N/A
Recruiting NCT04023448 - The Effect of Different Reconstruction Methods on Anterior Resection Syndrome N/A
Recruiting NCT04040842 - International Low Anterior Resection Score Evaluation
Not yet recruiting NCT06424522 - A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients Early Phase 1
Completed NCT05605600 - Translation of the International Consensus Definition of LARS Into a Bowl Dysfunction Severity Scoring Tool (New LARS Score)
Completed NCT05016583 - Paula Method of Exercises in Patients With LARS Syndrome N/A
Active, not recruiting NCT05042700 - The Effect of Melatonin in Patients With Low Anterior Resection Syndrome Phase 2
Recruiting NCT04612569 - Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.
Completed NCT04896879 - Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS
Recruiting NCT06162143 - Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome
Withdrawn NCT03257332 - Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.
Completed NCT03916549 - Acupuncture in Low Anterior Resection Syndrome Treatment Phase 1
Completed NCT05020132 - Bowel Dysfunction After Rectal Cancer Treatment
Completed NCT03598231 - Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome N/A
Recruiting NCT05420870 - Effect of Exercise on Bowel Function in Colorectal Cancer Survivors N/A
Completed NCT01589471 - The Value of Botox-A for Management of Low Anterior Resection Syndrome Phase 2
Completed NCT03215017 - Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery N/A
Completed NCT05129215 - Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)
Recruiting NCT05682157 - Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial N/A