International Low Anterior Resection Score Evaluation

Recruiting

• Conditions: Low Anterior Resection Syndrome

• Registration Number: NCT04040842
• Lead Sponsor: National Cancer Institute, Lithuania

Brief Summary

* 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-07-28
• Study First Submitted QC: 2019-07-31
• Study First Posted: 2019-08-01
• Study Start: 2019-09-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-07
• Last Update Posted: 2023-11-09
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LARS score change comparing before surgery and 1 year after the surgery.	12 months	Low anterior resection score is a simple questionnaire consisting of five simple questions for bowel function assessment after anterior resection. The maximum number is between 0 and 42. No LARS (good bowel function) is from 0 to 20; minor LARS - 21-29 and major LARS (poor bowel function) more than 29.; Between average LARS score before and after curative surgery and also comparing these with published LARS score on normal population.

Trial Locations

Locations (1)

National Cancer Institute; 🇱🇹 Vilnius, Lithuania