International Low Anterior Resection Score Evaluation (PrePostLARS)

National Cancer Institute, Lithuania

Status: Enrolling

Conditions: Low Anterior Resection Syndrome

Treatments: Diagnostic Test: Patients undergoing low anterior resection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04040842

ISUCRS

Details and patient eligibility

About

• Aim: The aim of this study is to perform a prospective, international 4 months cohort study evaluating bowel function before curative rectal cancer surgery and one year after the surgery using the LARS score.
• Primary outcome measure: LARS score before surgery and 1 year after the surgery.
• Primary comparison: Between average LARS score before and after curative surgery and also comparing these with publish LARS score on normal population.

Full description

All patients undergoing treatment for rectal rectal will be included in the study. Before any treatment all the included patients will be asked to fill the LARS score (5 question questionnaire with differently weighted answers for assessing the low anterior resection score). One year after the low anterior resection (without the stoma) or following the stoma take down patients will be reassessed. The LARS score will be filled one again. Patient characteristics, age, cancer stage, level of anastomosis will be assessed aswel.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing rectal cancer surgery on curative intent.
• Elective surgery patients.
• Laparoscopic, laparoscopic-converted, robotic, TaTME (transanal total mesorectal excision) and open cases will be included.
• Patients aged 18 years and over should be included.

Exclusion criteria

• Patients undergoing a procedure purely for diagnosis or staging should be excluded.
• Patients with palliative treatment.
• Patients with recurrence should be excluded.
• Patients with dementia
• Patients who do not complete their treatment within 12 months of primary surgery e.g. including reversal of stoma, chemotherapy etc