Spots Global Cancer Trial Database for Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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