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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05605600
Other study ID # 8395
Secondary ID 31361722/PR/0889
Status Completed
Phase
First received
Last updated
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
Health authority
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))

Study Design


Related Conditions & MeSH terms


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
See also
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Recruiting NCT04040842 - International Low Anterior Resection Score Evaluation
Not yet recruiting NCT06424522 - A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients Early Phase 1
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Active, not recruiting NCT05042700 - The Effect of Melatonin in Patients With Low Anterior Resection Syndrome Phase 2
Recruiting NCT04612569 - Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.
Completed NCT04896879 - Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS
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Completed NCT05020132 - Bowel Dysfunction After Rectal Cancer Treatment
Completed NCT03598231 - Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome N/A
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Active, not recruiting NCT05319054 - Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study N/A
Completed NCT01589471 - The Value of Botox-A for Management of Low Anterior Resection Syndrome Phase 2
Completed NCT03215017 - Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery N/A
Completed NCT05129215 - Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)
Recruiting NCT05682157 - Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial N/A