Bowel Dysfunction After Rectal Cancer Treatment

Low Anterior Resection Syndrome Clinical Trial

Official title:

Prospective Evaluation of Bowel Dysfunction After Rectal Cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05020132
• Other study ID #: LARS
• Status: Completed
• Start date: November 1, 2015
• Est. completion date: September 1, 2020

Study information

• Verified date: September 2023
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: September 1, 2020
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Diseases
• Low Anterior Resection Syndrome

Locations

Country	Name	City	State
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa	Hospital Universitari MútuaTerrassa

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the LARS score between baseline and 12 months	Change in the LARS score (Low Anterior Resection Score) between baseline and 12 months after bowel transit reconstruction (primary surgery or ileostomy closure). The LARS score is a 5-item scoring system which classifies patients into three severity categories: no LARS (0-20 points), minor LARS (21-29 points), and major LARS (30-42 points). A higher score represents worse bowel function. This score also includes a question about the impact on quality of life.	12 months
Primary	Change in the MSK-BFI between baseline and 12 months (MSK-BFI)	Change in the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (MSK-BFI) between baseline and 12 months after bowel transit reconstruction (primary surgery or ileostomy closure). The MSK-BFI includes 18 questions with five frequency options ranging from never through to always. A total score and three subscales (frequency, diet, and urgency) can be calculated. A higher score represents better bowel function.	12 months
Primary	Change in the Bristol stool chart between baseline and 12 months	Change in the Bristol stool chart between baseline and 12 months after bowel transit reconstruction (primary surgery or ileostomy closure). The Bristol stool chart shows seven categories of stool. The Bristol score was subclassified into three categories: Bristol 1-2 (hard stools), Bristol 3-4 (normal stools), and Bristol 5-7 (loose or liquid stools).	12 months
Secondary	Change in the Visual Analogue Scale (VAS) between baseline and 12 months	Change in the Visual Analogue Scale (VAS) between baseline and 12 months after bowel transit reconstruction (primary surgery or ileostomy closure). The VAS ranges from 0 (worst bowel function) to 10 (best)	12 months
Secondary	Change in the EORTC QLQ-C30 between baseline and 12 months	Change in the European Organization for Research and Treatment of Cancer Quality oF Life Questionnaire (EORTC QLQ-C30) between baseline and 12 months after bowel transit reconstruction (primary surgery or ileostomy closure). The EORTC QLQ-C30 is a self-administered questionnaire developed to assess the quality of life of patients with cancer. The global QoL scale and 5 functional scales (physical, role, cognitive, emotional, and social functioning) can be calculated. All scales range from 0 to 100. A higher score for the global health status represents a higher quality of life, and a higher score for a functional scale represents a higher / healthy level of functioning.	12 months
Secondary	Change in the Fecal Incontinence Quality of Life (FIQL) between baseline and 12 months	Change in the Fecal Incontinence Quality of Life (FIQL) between baseline and 12 months after bowel transit reconstruction (primary surgery or ileostomy closure). The FIQL score includes 29 items which form four scales: lifestyle, coping/behavior, depression/self-perception, and embarrassment. Scores range from 0 to 4 and a higher value represents a better quality of life.	12 months
Secondary	Correlation of the severity of LARS with the quality of life	Correlation of the severity of LARS (LARS score and MSK-BFI) with the quality of life (EORTC QLQ-C30)	12 months
Secondary	Multivariate analysis of risk factors for LARS	Assessment of independent predictors of the LARS score at the 12-month visit in a multiple linear regression model. Univariate linear regression analysis was initially performed to identify the demographic, clinical and surgical factors associated with the 12-month LARS score.	12 months