Prospective Evaluation of Bowel Dysfunction After Rectal Cancer Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Low Anterior Resection Syndrome
- Sponsor
- Consorci Sanitari de Terrassa
- Enrollment
- 113
- Locations
- 1
- Primary Endpoint
- Change in the MSK-BFI between baseline and 12 months (MSK-BFI)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Detailed 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.
Investigators
Yolanda Ribas
Principal Investigator
Consorci Sanitari de Terrassa
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in the MSK-BFI between baseline and 12 months (MSK-BFI)
Time Frame: 12 months
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.
Change in the Bristol stool chart between baseline and 12 months
Time Frame: 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).
Change in the LARS score between baseline and 12 months
Time Frame: 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.
Secondary Outcomes
- 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)
- Correlation of the severity of LARS with the quality of life(12 months)
- Multivariate analysis of risk factors for LARS(12 months)
- Change in the Fecal Incontinence Quality of Life (FIQL) between baseline and 12 months(12 months)