Informations générales (source: ClinicalTrials.gov)
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 (LARS)
Observational
University Hospital, Caen (Voir sur ClinicalTrials)
janvier 2020
décembre 2024
29 juin 2024
Oncological rectal cancer outcomes have improved considerably because of optimal surgery
by total mesorectal excision in conjunction with multidisciplinary team management by
selective multimodal therapy (ie, neo-adjuvant chemo-radiotherapy). The 5-year survival
has increased to more than 50% and local recurrence has been reduced to less than 10%.
These advancements have resulted in more patient receiving sphincter-preserving surgery
(SPS). With an increasing number of rectal cancer survivors, the investigators observe a
rising attention to the disordered bowel function after SPS, called "low anterior
resection syndrome" (LARS). LARS appear immediately after surgery, becoming most
pronounced during the first few months, and improved thereafter, reaching a steady state
after around two years. However, up to 60% of patients with SPS suffer from LARS which
impaired their quality of life (QoL). The prevalence and severity of LARS is difficult to
assess due to heterogeneity of the assessment tools. A group of Danish authors have
recently developed and validated a five-item instruments for evaluation of LARS (LARS
score). It represents to date the best questionnaire to capture anorectal postoperative
function and consists of five items: incontinence for flatus, incontinence for liquid
stool, frequency of bowel movements, clustering of stools, and urgency. It allows a
categorization of patients into 3 groups: no LARS (0-20 points), minor LARS (21-29
points), and major LARS (30-42 points). Developed in Danish, it is now internationally
validated with translations in Chinese, English, German, Spanish and Swedish. To our
knowledge, French version of the LARS score is not yet available. The aim of our study
will be to adapt the LARS scale questionnaire to the French language (LARS-F), and assess
its psychometric properties.
Inclusion criteria will be patients 18 years old or above who were operated for rectal
cancer from 2007 to 2015. Exclusion criteria will include the presence of stoma and/or
known disseminated or recurrent disease. Patients will be identified through local
databases by the local investigators at each of the participating centers with a minimum
duration of 24 months after surgery to allow their bowel function to have regained
stability. This study will be supported by the French Research Group of Rectal Cancer
Surgery in order to allow the feasibility of the project.
After translation/back-translation procedures in accordance with the permission from the
original authors, the LARS-F score and the whole translation process will be then sent to
the original authors for approval. Then a pilot study will be conducted. The French
questionnaire (LARS-F score) will be then administered to 100 patients in order to verify
the adequacy and degree of comprehension of the questions. Reproducibility will be
investigated by a test-retest procedure. A randomly selected subgroup of participants (n=
400) will be sent the LARS-F score questionnaire twice (with an interval of two weeks).
The test-retest reliability of the questionnaire will be assessed by the Cohen's Kappa
(no, minor and major LARS scores) or by intra-class correlation coefficient, ICC
(quantitative LARS score). Then, eligible patients will receive a postal invitation to
complete the LARS-F score and the l'European Organization for Research and treatment of
Cancer (EORTC) QLQ-C30 and QLQ-CR29, respectively. The validity of the LARS-F score will
be tested by using the indicators of convergent validity and discriminant validity. The
convergent validity will be determined notably in this study by computing the
correlations between the LARS-F score and the EORTC QLQ-C30 and QLQ-CR29 domains. For
discriminant validity testing, the investigators will use known variables to affect bowel
function after SPS, such as gender, age, neo-adjuvant radiation therapy, distance of the
tumor from the anal verge, prior temporary stoma, and length of postoperative period.
The validation of the French version of the LARS score will allow to use a scientific
instrument in order to assess both prevalence and severity of LARS. This instrument will
allow to develop a future research and clinical practice in France. It will be used in
the daily clinical practice to identify patients with LARS score. It will hopefully lead
to improve the awareness of clinicians, in order to improve the prevention and the
treatment of bowel dysfunction, as well as the information given to patients. In the
future, the investigators will able to develop a new patient-led follow-up program based
on symptom burden and health-related QoL.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | L�onor BENHAIM | 08/03/2024 13:08:44 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Caen University Hospital - Caen - France | Arnaud Alvès, MD, PhD | Contact (sur clinicalTrials) | |||
| Chru Amiens - 60000 - Amiens - France | jean marc regimbeau, MD,PhD | Contact (sur clinicalTrials) | |||
| Chru Nancy - 57000 - Nancy - France | laurent bresler, MD, PhD | Contact (sur clinicalTrials) | |||
| Chru Tours - Tours - France | mehdi ouaissi, MD, PhD | Contact (sur clinicalTrials) | |||
| clc VANDEUVRE LES NANCY - 57000 - Vandœuvre-lès-Nancy - France | frédéric marchal, MD,PhD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chru Lille - 59000 - Lille - France | guillaume piessen, MD, PhD | Contact (sur clinicalTrials) | |||
| Chru Nantes - Nantes - France | guillaume meurette, MD,PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- The presence of stoma and/or known disseminated or recurrent disease
- Other diseases of bowel dysfunction (Crohn's disease)
- Cognition and/or language issues.