International Low Anterior Resection Score Evaluation

Low Anterior Resection Syndrome Clinical Trial

— PrePostLARS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04040842
• Other study ID #: ISUCRS
• Status: Recruiting
• Start date: September 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2023
• Source: National Cancer Institute, Lithuania
• Contact: Audrius Dulskas, MD, PhD
• Phone: 867520094
• Email: audrius.dulskas[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Low Anterior Resection Syndrome
• Syndrome

Intervention

Diagnostic Test:
• Patients undergoing low anterior resection
Patients before the surgery and one year after the surgery will be assessed with questionnaire.

Locations

Country	Name	City	State
Lithuania	National Cancer Institute	Vilnius

Sponsors (3)

Lead Sponsor	Collaborator
National Cancer Institute, Lithuania	King's College London, National Cancer Institute (NCI)

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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