Evidence map›Paper›PMID 32152168›Full record

Observational studyBMJ open2020

'French LARS score': 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: a study protocol.

Yassine Eid, Véronique Bouvier, Olivier Dejardin, Benjamin Menahem, Fabien Chaillot, Yannick Chene, Jean Jacques Dutheil, Therese Juul, Rémy Morello, Arnaud Alves

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03569488 (Validation of the French Version of the Low Anterior Resection Syndrome), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03569488 unknown statusnot on this map

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

TypeobservationalSponsorUniversity Hospital, CaenRan2020 to 2024Enrolled1,100ConditionsRectal Cancer PatientsArmsFT-LARS questionnaire
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Yassine EidDepartment of digestive surgery, University Hospital of Caen, Caen, France eidyassine@hotmail.fr.ORCID 0000-0002-0369-8454
Véronique BouvierANTICIPE" U1086 INSERM-University of Caen Normandy, Team « Ligue contre le Cancer », Centre François Baclesse, Caen, France.
Olivier DejardinANTICIPE" U1086 INSERM-University of Caen Normandy, Team « Ligue contre le Cancer », Centre François Baclesse, Caen, France.
Benjamin MenahemDepartment of digestive surgery, University Hospital of Caen, Caen, France.
Fabien ChaillotDepartment of research, University Hospital of Caen, Normandy, France.
Yannick CheneDepartment of research, University Hospital of Caen, Normandy, France.
Jean Jacques DutheilDepartment of research, University Hospital of Caen, Normandy, France.
Therese JuulDepartment of Surgery, Aarhus University Hospital, Aarhus, Denmark.
Rémy MorelloDepartment of research, University Hospital of Caen, Normandy, France.
Arnaud AlvesDepartment of digestive surgery, University Hospital of Caen, Caen, France.

Funding

EPA EP-C-17-031
6 · The paper itself

Abstract

introductionMany bowel problems following low anterior resection (LAR) for rectal cancer considerably impair the quality of life (QoL) of patients. The LAR syndrome (LARS) scale is a self-report questionnaire to identify and assess bowel dysfunction after rectal cancer surgery. It has been translated and validated in several languages but not in French (metropolitan French). The primary objective is to adapt the LARS scale to the French language (called French-LARS score) and to assess its psychometric properties. Secondary objectives are to assess both the prevalence and severity of LARS and to measure their impact on QoL. METHODS AND ANALYSIS: A French multicentre observational cohort study has been designed. The validation study will include translation of the LARS scale following the current international recommendations, assessment of its reliability, convergent and discriminant validities, sensitivity, internal consistency, internal validity and confirmatory analyses. One thousand patients will be enrolled for the analyses. The questionnaire will be initially administered to the first 100 patients to verify the adequacy and degree of comprehension of the questions. Then reproducibility will be investigated by a test-retest procedure in the following 400 patients.An analysis will be conducted to determine the correlation between the LARS score and the Quality of Life Questionnaire (QLQ; European Organization for Treatment and Research of Cancer's QLQ-C30, QLQ-CR29). Risk factors linked to QoL deterioration will be identified and their impact will be measured. This study will meet the need for a validated tool to improve patient care and QoL. ETHICS AND DISSEMINATION: The institutional review board of the University Hospital of Caen and the ethics committee (CPP Nord Ouest I, 25 January 2019) approved the study. TRIAL REGISTRATION NUMBER: NCT03569488.

Indexed as

Fecal IncontinencePostoperative ComplicationsRectal NeoplasmsSurveys and QuestionnairesBody Mass IndexFranceHumansPsychometricsQuality of LifeReproducibility of ResultsResearch DesignSocioeconomic FactorsTime FactorsTranslatingTumor Burdenbowel dysfunctioncolorectal functional outcomelow anterior resection syndromequality of liferectal cancervalidation

Identifiers

PMID32152168
PMCPMC7064062

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.