Validation of the Moroccan Arabic Version of the Low Anterior Resection Syndrome (LARS) and Wexner Score of Continence Among Rectal Cancer Patients (MA_LARSWEX)

• ClinicalTrials.gov Identifier: NCT04128657
• Recruitment Status: Completed
• First Posted: October 16, 2019
• Last Update Posted: February 20, 2020
• Sponsor: Moroccan Society of Surgery
• Collaborator: Institut National d'Oncologie Sidi Mohammed Ben Abdellah
• Information provided by (Responsible Party): Amine Souadka, Moroccan Society of Surgery

Tracking Information

• First Submitted Date: October 13, 2019
• First Posted Date: October 16, 2019
• Last Update Posted Date: February 20, 2020
• Actual Study Start Date: January 1, 2019
• Actual Primary Completion Date: October 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 15, 2019)

• 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 )
• 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

Original Primary Outcome Measures (submitted: October 13, 2019)

• Validation of the moroccan arabic version of the LARS score [ Time Frame: 6 months after surgery ]
  Validation of the MA_LARS score
• Validation of the moroccan arabic version of the Wexner score [ Time Frame: 6 months after surgery ]
  validation of the MA_Wexner score

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Validation of the Moroccan Arabic Version of the Low Anterior Resection Syndrome (LARS) and Wexner Score of Continence Among Rectal Cancer Patients
• Official Title: 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

Brief Summary

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.

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: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Volantary patient with curative sphincter preserving surgery with no defuntioning stoma who accept to participate in the MA_LARS and MA_Wexner scores validation study
• Condition: Rectal Cancer Patients

Intervention

Diagnostic Test: MA_LARS

Validation of the MA_LARS and MA_Wexner

Other Name: MA_Wexner

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 18, 2020): 143
• Original Estimated Enrollment (submitted: October 13, 2019): 102
• Actual Study Completion Date: October 31, 2019
• Actual Primary Completion Date: October 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Morocco

Administrative Information

• NCT Number: NCT04128657
• Other Study ID Numbers: LARS_Wexner_MA
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Amine Souadka, Moroccan Society of Surgery
• Study Sponsor: Moroccan Society of Surgery
• Collaborators: Institut National d'Oncologie Sidi Mohammed Ben Abdellah
• Investigators: Not Provided
• PRS Account: Moroccan Society of Surgery
• Verification Date: February 2020