Rectal Cancer Patients Clinical Trial
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
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03569488 -
Validation of the French Version of the Low Anterior Resection Syndrome (LARS) Among Rectal Cancer Patients
|
||
| Withdrawn |
NCT01426074 -
DCE-MRI PET Bevacizumab Study in Rectal Cancer
|
Phase 2 |