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International Low Anterior Resection Score Evaluation

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04040842
Acronym
PrePostLARS
Enrollment
400
Registered
2019-08-01
Start date
2019-09-01
Completion date
2023-12-31
Last updated
2023-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Anterior Resection Syndrome

Keywords

Rectal cancer, low anterior resection, low anterior resection syndrome

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.

Interventions

DIAGNOSTIC_TESTPatients undergoing low anterior resection

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

Sponsors

King's College London
CollaboratorOTHER
National Cancer Institute (NCI)
CollaboratorNIH
National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
LARS score change comparing before surgery and 1 year after the surgery.12 monthsLow 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.

Countries

Lithuania

Contacts

Primary ContactAudrius Dulskas, MD, PhD
audrius.dulskas@gmail.com867520094
Backup ContactPovilas Kavaliauskas, MD
povilaskava@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026