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Clinical Trial Summary

Bowel dysfunction after rectal cancer treatment may significantly affect the quality of life. Our study aimed to estimate the incidence and characterize the Low Anterior Resection Syndrome(LARS). We performed a prospective evaluation of patients treated with anterior resection for rectal cancer at two hospitals. Assessment was performed at baseline, after neoadjuvant treatment, and 1, 6 and 12 months after bowel transit reconstruction using the following scores: Bristol scale, LARS score, MSK-BFI, FIQL, EORTC-QLQ30 and a visual analogue scale.


Clinical Trial Description

Low anterior resection syndrome (LARS) refers to wide-ranging symptoms including evacuatory dysfunction, fecal urgency and incontinence. The assessment of bowel dysfunction after rectal cancer treatment has improved since the development of the LARS score. This score has widely been used with a meta-analysis reporting a pooled prevalence of "major LARS" of 41%. However, several studies have found a large proportion of patients with major LARS in the general population without rectal cancer raising questions about the specificity of this score. Moreover, most studies on the prevalence of LARS do not include a baseline evaluation and, therefore, may not allow establishing whether the dysfunctions appeared after the treatment. Consequently, we considered that a prospective study including a baseline evaluation and multiple validated questionnaires was required. The present study aimed to estimate the incidence and characterize bowel dysfunction after rectal cancer treatment. The results of this study will be useful to improve the preoperative information given to the patient and the shared decision-making process. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05020132
Study type Observational [Patient Registry]
Source Consorci Sanitari de Terrassa
Contact
Status Completed
Phase
Start date November 1, 2015
Completion date September 1, 2020

See also
  Status Clinical Trial Phase
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Completed NCT05016583 - Paula Method of Exercises in Patients With LARS Syndrome N/A
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Active, not recruiting NCT05319054 - Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study N/A
Completed NCT01589471 - The Value of Botox-A for Management of Low Anterior Resection Syndrome Phase 2
Completed NCT03215017 - Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery N/A
Completed NCT05129215 - Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)
Recruiting NCT05682157 - Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial N/A