Clinical Trials Directory

Trials / Completed

CompletedNCT05605600

Translation of the International Consensus Definition of LARS Into a Bowl Dysfunction Severity Scoring Tool (New LARS Score)

A Qualitative Research Study Using Patient Focus Groups to Translate International Consensus Definition of Low Anterior Resection Syndrome (LARS) Into a Bowel Dysfunction Severity Scoring Tool.

Status
Completed
Phase
Study type
Observational
Enrollment
8 (actual)
Sponsor
Cardiff and Vale University Health Board · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to develop a new severity scoring tool for Low Anterior Resection Syndrome (LARS) drawing on the international consensus criteria for LARS as well as opinions of patients with lived-experience of LARS.

Detailed description

Six out of ten patients have significant bowel problems in the first 12 months after surgery to remove their rectum (last bit of bowel), with as many as 4 out of 10 having longer term issues. This is an operation which is most commonly performed to treat bowel cancer. Bowel problems can include having to rush to the toilet, having accidents or leakage into the underwear or difficulty fully emptying the bowels. This condition is called Low Anterior Resection Syndrome, or 'LARS' for short. The definition of Low Anterior Resection Syndrome was developed in 2020 with patient involvement throughout the process so it accurately captures the real-world experience of LARS. This definition is to be used to create a new scoring system to measure the severity of LARS. The aim of this study is to transform this new definition into a scoring tool which can be used to assess the severity of Low Anterior Resection Syndrome and investigate how well various treatments work for LARS. It is vital to have patients involved throughout this work to ensure that the new score gives an accurate picture of the severity of these symptoms.

Conditions

Timeline

Start date
2022-10-03
Primary completion
2023-03-31
Completion
2023-03-31
First posted
2022-11-04
Last updated
2023-04-05

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05605600. Inclusion in this directory is not an endorsement.