Clinical trial NCT05020132: Bowel Dysfunction After Rectal Cancer Treatment
Official title: Prospective Evaluation of Bowel Dysfunction After Rectal Cancer Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Anterior Resection Syndrome
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
Collaborators: name: Hospital Universitari MútuaTerrassa
First posted: 2021-08-25
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with anterior resection for rectal adenocarcinoma with curative intention, with or without neoadjuvant chemoradiotherapy

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.

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

Primary outcomes:
measure: Change in the LARS score between baseline and 12 months
timeFrame: 12 months
measure: Change in the MSK-BFI between baseline and 12 months (MSK-BFI)
timeFrame: 12 months
measure: Change in the Bristol stool chart between baseline and 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change in the Visual Analogue Scale (VAS) between baseline and 12 months
timeFrame: 12 months
measure: Change in the EORTC QLQ-C30 between baseline and 12 months
timeFrame: 12 months
measure: Change in the Fecal Incontinence Quality of Life (FIQL) between baseline and 12 months
timeFrame: 12 months
measure: Correlation of the severity of LARS with the quality of life
timeFrame: 12 months
measure: Multivariate analysis of risk factors for LARS
timeFrame: 12 months
Other outcomes:
Locations:
city: Terrassa
country: Spain
facility: Consorci Sanitari de Terrassa
state: Barcelona
Study officials:
References: