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

Low Anterior Resection Syndrome Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05605600
• Other study ID #: 8395
• Secondary ID: 31361722/PR/0889
• Status: Completed
• Start date: October 3, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: July 2022
• Source: Cardiff and Vale University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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))

Related Conditions & MeSH terms

• Low Anterior Resection Syndrome
• Syndrome

Locations

Country	Name	City	State
United Kingdom	Julie Cornish	Cardiff

Sponsors (4)

Lead Sponsor	Collaborator
Cardiff and Vale University Health Board	Cambridge University Hospitals NHS Foundation Trust, University of Aarhus, University of Auckland, New Zealand

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of LARS Severity tool	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.	6 months
Secondary	Gain patient opinion on new scoring tool name	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.	6 months
Secondary	Commence initial psychometric evaluation of the New LARS score	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.	6 months