Validation of the French LARS score for rectal cancer patients
Validation of the French Version of the Low Anterior Resection Syndrome (LARS) Score for Measuring Bowel Dysfunction After Sphincter-preserving Surgery Among Rectal Cancer Patients
This study is testing the French version of a score that measures bowel function problems in rectal cancer patients after surgery to see if it works well for helping doctors understand their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Caen Academic / other |
| Drugs / interventions | radiation |
| Locations | 8 sites (Amiens and 7 other locations) |
| Trial ID | NCT03569488 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the French version of the Low Anterior Resection Syndrome (LARS) score among rectal cancer patients who have undergone sphincter-preserving surgery. It involves assessing the prevalence and severity of LARS, a condition that affects bowel function after surgery, which can significantly impair quality of life. Eligible patients will complete the LARS-F score and other quality of life questionnaires to evaluate the psychometric properties of the translated score. The study seeks to ensure that the French version of the LARS score is both reliable and valid for use in clinical settings.
Who should consider this trial
Good fit: Ideal candidates are rectal cancer patients aged 18 to 80 who have undergone curative sphincter-preserving surgery and have had bowel continuity restored for at least 24 months.
Not a fit: Patients with a stoma, recurrent disease, or other bowel dysfunctions such as Crohn's disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a validated tool for assessing bowel function and quality of life in rectal cancer survivors, leading to better patient management.
How similar studies have performed: Other studies have successfully validated similar assessment tools for quality of life in cancer patients, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 80 years * Rectal cancer patients undergoing curative sphincter-preserving surgery with partial or total mesorectal excision * Surgery performed between January 2007 to January 2016, with reversal of the defunctioning stoma before January 2016; * Hence all patients had had bowel continuity restored for at least 24 months Voluntarily participated in the study Exclusion Criteria: * The presence of stoma and/or known disseminated or recurrent disease * Other diseases of bowel dysfunction (Crohn's disease) * Cognition and/or language issues.
Where this trial is running
Amiens and 7 other locations
- Chru Amiens — Amiens, France (Recruiting)
- Caen University Hospital — Caen, France (Recruiting)
- Chru Lille — Lille, France (Recruiting)
- Centre Oscar Lambret — Lille, France (Recruiting)
- Chru Nancy — Nancy, France (Recruiting)
- Chru Nantes — Nantes, France (Recruiting)
- Chru Tours — Tours, France (Recruiting)
- clc VANDEUVRE LES NANCY — Vandœuvre-lès-Nancy, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.