International Low Anterior Resection Score Evaluation (PrePostLARS)

Quality and Outcomes in Global Cancer Surgery: a Prospective, International Cohort Study Evaluating Low Anterior Resection Syndrome (LARS)

• 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.

Study Overview

• Status: Recruiting
• Conditions: Low Anterior Resection Syndrome
• Intervention / Treatment: Diagnostic test: Patients undergoing low anterior resection

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Audrius Dulskas, MD, PhD; Phone Number: 867520094; Email: audrius.dulskas@gmail.com
• Study Contact Backup: Name: Povilas Kavaliauskas, MD; Email: povilaskava@gmail.com

Study Locations

• Lithuania
  • Vilnius, Lithuania, 08406
    • Recruiting
    • National Cancer Institute
    • Contact: Audrius Dulskas, MD, PhD; Phone Number: 852786812; Email: audrius.dulskas@gmail.com
    • Sub-Investigator: Povilas Kavaliauskas
    • Principal Investigator: Joseph Nunoo-mensah, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LARS score change comparing before surgery and 1 year after the surgery.	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.	12 months

Collaborators and Investigators

• Sponsor: National Cancer Institute, Lithuania
• Collaborators: National Cancer Institute (NCI); King's College London
• Investigators: Study Director: Joseph Nunoo-Mensah, MD, King's College

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: July 28, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (Actual): August 1, 2019

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Rectal cancer; low anterior resection; low anterior resection syndrome
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Syndrome; Low Anterior Resection Syndrome
• Other Study ID Numbers: ISUCRS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No