International Low Anterior Resection Score Evaluation

NCT04040842 | Unknown

• 1 other identifier: ISUCRS
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Anterior Resection Syndrome

Keywords

Rectal cancer; low anterior resection; low anterior resection syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Patients undergoing low anterior resection DIAGNOSTIC_TEST

Patients before the surgery and one year after the surgery will be assessed with questionnaire.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos: lead
• King's College London: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

National Cancer Institute

Vilnius, 08406, Lithuania

RECRUITING

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Joseph Nunoo-Mensah, MD

  King's College

  STUDY DIRECTOR

Central Study Contacts

Audrius Dulskas, MD, PhD

CONTACT

867520094; audrius.dulskas@gmail.com

Povilas Kavaliauskas, MD

CONTACT

povilaskava@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. professor

Study Record Dates

• First Submitted: July 28, 2019
• First Posted: August 1, 2019
• Study Start: September 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

LI (1)