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

NCT04128657 | Completed DMC

• 1 other identifier: LARS_Wexner_MA
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 2

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.

Conditions

Rectal Cancer Patients

Keywords

Quality of life; Sphincter sparing surgery; Wexner score; LARS score

Outcome Measures

Primary Outcomes (2)

• Validation of the moroccan arabic version of the LARS score

  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

  validation of the Moroccan arabic Wexner score; 0 perfect score and 20 complete incontinence

  6 months after surgery

Interventions

MA_LARS DIAGNOSTIC_TEST

Validation of the MA\_LARS and MA\_Wexner

Also known as: MA_Wexner

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Palliative surgery.
• The presence of a definitive iliac or perineal stoma.
• Diseases of bowel dysfunction (Crohn's disease)
• Cognitive and/or language issues.

Sponsors & Collaborators

• Moroccan Society of Surgery: lead
• Institut National d'Oncologie Sidi Mohammed Ben Abdellah: collaborator

Study Sites (2)

National Institut of Oncology, Surgical oncology department

Rabat, Please Enter the State Or Province, 10100, Morocco

Location

Private surgical oncology center

Salé, Morocco

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 16, 2019
• Study Start: January 1, 2019
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

MO (2)