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RecruitingNCT04040842PrePostLARSUpdated Nov 9, 2023

International Low Anterior Resection Score Evaluation

An observational study in Low Anterior Resection Syndrome, sponsored by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos. Recruiting at 1 site in Lithuania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-09.

Sponsored by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Low Anterior Resection Syndrome

Keywords

  • Rectal cancer
  • low anterior resection
  • low anterior resection syndrome
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
400 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testPatients undergoing low anterior resection

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

05

What researchers measure

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.

    Time frame: 12 months

06

Study locations

1 of 1 sites recruiting
  • National Cancer Institute
    Vilnius, 08406, Lithuania
    • Audrius Dulskas, MD, PhD · Contact · audrius.dulskas@gmail.com · 852786812
    • Povilas Kavaliauskas · Sub investigator
    • Joseph Nunoo-mensah, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04040842
Lead sponsor
National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos
Collaborators
King's College London, National Cancer Institute (NCI)
Responsible party
Audrius Dulskas (Assoc. professor, National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos) — Principal investigator
First posted
Aug 1, 2019
Start date
Sep 1, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Nov 9, 2023

Study contacts

Audrius Dulskas, MD, PhD
Contact
audrius.dulskas@gmail.com
867520094
Povilas Kavaliauskas, MD
Contact
povilaskava@gmail.com
Joseph Nunoo-Mensah, MD
study director · King's College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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