NCT05020132

Bowel Dysfunction After Rectal Cancer Treatment

Prospective Evaluation of Bowel Dysfunction After Rectal Cancer Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 113 (actual)
• Sponsor: Consorci Sanitari de Terrassa · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Anterior Resection Syndrome

Timeline

• Start date: 2015-11-01
• Primary completion: 2018-09-30
• Completion: 2020-09-01
• First posted: 2021-08-25
• Last updated: 2023-09-28

Locations

1 site across 1 country: Spain