Bowel Dysfunction After Rectal Cancer Treatment

NCT05020132 | Completed

• 1 other identifier: LARS
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Low Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (5)

• Change in the Visual Analogue Scale (VAS) between baseline and 12 months

  12 months

• Change in the EORTC QLQ-C30 between baseline and 12 months

  12 months

• Change in the Fecal Incontinence Quality of Life (FIQL) between baseline and 12 months

  12 months

• Correlation of the severity of LARS with the quality of life

  12 months

• Multivariate analysis of risk factors for LARS

  12 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with anterior resection for rectal adenocarcinoma with curative intention, with or without neoadjuvant chemoradiotherapy

You may qualify if:

• 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.

You may not qualify if:

• disseminated disease
• surgery with palliative intent
• refusal to participate in the study
• intellectual difficulty to answer the questionnaires

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead
• Hospital Universitari MútuaTerrassa: collaborator

Study Sites (1)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

MeSH Terms

Conditions

Low Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 25, 2021
• Study Start: November 1, 2015
• Primary Completion: September 30, 2018
• Study Completion: September 1, 2020
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

ES (1)