Clinical trial NCT05605600: Translation of the International Consensus Definition of LARS Into a Bowl Dysfunction Severity Scoring Tool (New LARS Score)
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Anterior Resection Syndrome
Keywords: Qualitative Research
Patient-Reported Outcome Measures
Colorectal Cancer
Bowel Dysfunction
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
Collaborators: name: University of Auckland, New Zealand
name: University of Aarhus
name: Cambridge University Hospitals NHS Foundation Trust
First posted: 2022-11-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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))

Primary outcomes:
measure: Development of LARS Severity tool
timeFrame: 6 months
Secondary outcomes:
measure: Gain patient opinion on new scoring tool name
timeFrame: 6 months
measure: Commence initial psychometric evaluation of the New LARS score
timeFrame: 6 months
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Julie Cornish
Study officials:
affiliation: Cardiff and Vale University Health Board
name: Julie Cornish
role: PRINCIPAL_INVESTIGATOR
References: