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Completed

NCT Number: NCT05605600

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older
  • Able and willing to provide informed consent
  • Undergone an anterior resection for cancer, with current bowel continuity

Exclusion criteria

  • Currently undergoing adjuvant therapy
  • Recurrent or metastatic disease
  • Unable to participate to complete study procedures (Due to intellectual or cognitive impairment; Due to insufficient English-language skills (oral and written))

Treatment and study plan

Primary outcomes

  1. Development of LARS Severity tool

    Time frame: 6 months

    Qualitative research methods will be used develop the new tool. A patient focus group will be conducted to review the draft questionnaire and refine question and response wordings.

Secondary outcomes

  1. Gain patient opinion on new scoring tool name

    Time frame: 6 months

    Focus groups will be asked to rank proposed tool names from 'least favoured' to 'most favoured'. This will be considered along with clinical opinion to derive final tool name.

  2. Commence initial psychometric evaluation of the New LARS score

    Time frame: 6 months

    Participants will be asked to complete the new LARS score tool, along with existing LARS tool to test proposed question set and administration method as well as comparability to existing tool.

Sponsors and collaborators

Lead sponsor

Cardiff and Vale University Health Board

Other Gov

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust
  • University of Aarhus
  • University of Auckland, New Zealand

Registry information

Official study title

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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2022
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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