Bowel Dysfunction After Rectal Cancer Treatment

Status Completed

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

Clinical Trial Details

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

View Details

See also
Status	Clinical Trial	Phase
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Recruiting	`NCT04040842` - International Low Anterior Resection Score Evaluation
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Completed	`NCT05605600` - Translation of the International Consensus Definition of LARS Into a Bowl Dysfunction Severity Scoring Tool (New LARS Score)
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Recruiting	`NCT04612569` - Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.
Completed	`NCT04896879` - Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS
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Completed	`NCT03916549` - Acupuncture in Low Anterior Resection Syndrome Treatment	Phase 1
Completed	`NCT03598231` - Effectiveness of Sacral Neuromodulation in Low Anterior Resection 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