Bowel Dysfunction After Rectal Cancer Treatment

NCT ID: NCT05020132

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-01

Study Completion Date

2020-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Low Anterior Resection Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Patients with anterior resection for rectal adenocarcinoma with curative intention, with or without neoadjuvant chemoradiotherapy, total or partial excision of the mesorectum, colorectal or coloanal anastomosis.

Exclusion Criteria

* disseminated disease
* surgery with palliative intent
* refusal to participate in the study
* intellectual difficulty to answer the questionnaires
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari MĂștuaTerrassa

UNKNOWN

Sponsor Role collaborator

Consorci Sanitari de Terrassa

OTHER

Sponsor Role lead

Responsible Party

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Yolanda Ribas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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LARS

Identifier Type: -

Identifier Source: org_study_id

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