- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04128657
Validation of the Moroccan Arabic Version of the Low Anterior Resection Syndrome (LARS) and Wexner Score of Continence Among Rectal Cancer Patients (MA_LARSWEX)
Validation of the Morocan Arabic Version of the Low Anterior Resection Syndrome (LARS) Score for Measuring Bowel Dysfunction and Wexner Score of Incontinence After Sphincter-preserving Surgery Among Rectal Cancer Patients
In the past decade, colorectal cancer management improved considerably with total mesorectal excision as well as the multidisciplinary management relying on neoadjuvant radiochemotherapy. This forward leap is currently responsible for an increase in the survivorship of colorectal cancer patients to more than 50% at 5 years. Additively the surgical approach is now more inclined towards sphincter preserving procedures, which allows the conservation of body image but can have negative bowel function repercussions consisting of urgency and incontinence ; all these terms encompassed in the low anterior resection syndrome.
In the light of these findings many studies developed assessment tools in order to objectively measure this functional alteration among which are the low anterior resection syndrome questionnaire (LARS) and the WEXNER score. These tools designed to assess bowel function after sphincter-preserving surgery are now translated and validated into various languages and used in different countries.
The LARS score relies on the frequency of the symptoms and allows the categorization of patients into 3 groups: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points). It assesses the frequency of emptying, incontinence ( liquid, gas ), and other symptoms such as urgency and incomplete voiding. On the other hand, the WEXNER score relies on the examination of the frequency of three types of fecal incontinence (solid, liquid, and gas) and their consequences (pad wearing and lifestyle alteration) with frequency options ranging from never (score 0) through to always (meaning at least once per day; score 4). The score ranges from 0 (perfect continence) to 20 (complete incontinence).
The aim of our study is to adapt and validate the LARS and WEXNER score to the moroccan arabic dialect.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The translation of the LARS and WEXNER score to the moroccan dialect ( arabic ) has been done in another study using translation and back translation in concordance with the international guidelines. The questionnaire is administered to a total of 102 patients either directly or via telephone. Reproducibility will be tested through test and retest as one sub-group will be administered the questionnaire twice with an interval of 1 to 2 weeks. Patients will also be administered the questionnaires of the European Organization for Research and treatment of Cancer (EORTC) : QLQ-C30.
The validity of the LARS and WEXNER score will be tested by using the indicators of discriminant validity and convergent validity which will be determined in this study by computing the correlations between the LARS and WEXNER scores to the EORTC QLQ-C30.
For discriminant validity testing, variables used will be factors known to affect bowel function after colorectal surgery such as gender, age, neoadjuvant therapy, distance of the tumor from the anal verge, prior temporary stoma, length of postoperative period, the need for a reintervention and the occurrence of complications.
We recruited for our study patients treated in the National Oncology Institute of Rabat and in the Al azhar oncology center in the surgical department of Pr. Souadka Abdelilah with a minimum post operative interval of 6 months.
The validation of a moroccan dialectical version of the LARS score and WEXNER score will allow a better understanding of the bowel function post surgery and thereby the identification of patients with the highest scores which will allow a better understanding and possible inclusion of these tools in patient outcome assessment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Salé, Morocco
- Private surgical oncology center
-
-
Please Enter The State Or Province
-
Rabat, Please Enter The State Or Province, Morocco, 10100
- National Institut of Oncology, Surgical oncology department
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged older than 18 years.
- Neoplasm of the rectum.
- Rectal cancer patients undergoing curative sphincter-preserving surgery with (partial or total) mesorectal excision.
- Surgery performed between January 2012 to March 2019, with reversal of the defunctioning stoma before March 2019;
- Bowel continuity restoration for at least 6 months.
- Consent to participate in the study.
Exclusion Criteria:
- Palliative surgery.
- The presence of a definitive iliac or perineal stoma.
- Diseases of bowel dysfunction (Crohn's disease)
- Cognitive and/or language issues.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Validation of the moroccan arabic version of the LARS score
Time Frame: 6 months after surgery
|
Validation of the Moroccan arabic Low anterior resection syndrome (LARS) score ; 0 to 20 (no LARS), 21 to 29 (minor LARS ) and 30 to 42 (Major LARS )
|
6 months after surgery
|
Validation of the moroccan arabic version of the Wexner score
Time Frame: 6 months after surgery
|
validation of the Moroccan arabic Wexner score; 0 perfect score and 20 complete incontinence
|
6 months after surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LARS_Wexner_MA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rectal Cancer Patients
-
Centre Antoine LacassagneCompletedNon-metastatic Patients With Breast Cancer | Non-metastatic Patients With Colon Cancer | Non-metastatic Patients With Rectal Cancer | Patients Undergoing Adjuvant ChemotherapyFrance
-
Check-Cap Ltd.CompletedHigh Risk (Above Average) Subjects | Non Compliant Patients for Colo Rectal Cancer [CRC] Screening | Counterindicated Patients for ColonoscopyIsrael
-
Grupo Espanol Multidisciplinario del Cancer DigestivoRecruitingPatients With Locally Advanced Rectal CancerSpain
-
Abramson Cancer Center of the University of PennsylvaniaWithdrawnRectal Cancer Patients
-
University Health Network, TorontoPrincess Margaret Hospital, CanadaWithdrawnAnal Cancer Patients | Perianal Patients
-
Assistance Publique - Hôpitaux de ParisCompletedPatients With Rectal CancerFrance
-
University of JordanSlovak Academy of Sciences; Al-Quds UniversityUnknownRadiation-induced Injuries in Patients With Rectal CancerPalestinian Territory, occupied
-
Assiut UniversityNot yet recruitingthe Prognostic Value of Pre-treatment NLR in Patients With Locally Advenced Rectal Cancer and Post-treatment
-
University Hospital, CaenInstitut National de la Santé Et de la Recherche Médicale, France; National... and other collaboratorsRecruitingRectal Cancer PatientsFrance
-
Fondazione Policlinico Universitario Agostino Gemelli...Recruiting