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

NCT05605600 | Completed

• 3 other identifiers: 839531361722/PR/0889
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Anterior Resection Syndrome

Keywords

Qualitative Research; Patient-Reported Outcome Measures; Colorectal Cancer; Bowel Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Gain patient opinion on new scoring tool name

  6 months

• Commence initial psychometric evaluation of the New LARS score

  6 months

Study Arms (1)

Patients with Low Anterior Resection Syndrome

Patients with lived-experience of anterior resection surgery, who may or may not have subsequently developed bowel dysfunction symptoms, will be invited to take part in a focus group. They will discuss a new questionnaire and the phrasing of the questions, ensuring clarity and reducing the potential variability in interpretation of each question.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The aim of this study is to develop a new scoring tool for Low Anterior Resection Syndrome through patient focus groups. We will identify and recruit patients with lived-experience of anterior resection surgery, who may or may not have subsequently developed bowel dysfunction symptoms.

You may qualify if:

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

You may not qualify if:

• 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))

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• University of Auckland, New Zealand: collaborator
• University of Aarhus: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Julie Cornish

Cardiff, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Colorectal Neoplasms; Intestinal Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Julie Cornish

  Cardiff and Vale University Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 4, 2022
• Study Start: October 3, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 5, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)