International Low Anterior Resection Score Evaluation

NCT ID: NCT04040842

Last Updated: 2023-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-01

Study Completion Date

2023-12-31

Brief Summary

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* 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

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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.

Conditions

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Low Anterior Resection Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Patients undergoing low anterior resection

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College London

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

OTHER

Sponsor Role lead

Responsible Party

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Audrius Dulskas

Assoc. professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph Nunoo-Mensah, MD

Role: STUDY_DIRECTOR

King's College

Locations

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National Cancer Institute

Vilnius, , Lithuania

Site Status RECRUITING

Countries

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Lithuania

Central Contacts

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Audrius Dulskas, MD, PhD

Role: CONTACT

867520094

Povilas Kavaliauskas, MD

Role: CONTACT

Facility Contacts

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Audrius Dulskas, MD, PhD

Role: primary

852786812

Other Identifiers

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ISUCRS

Identifier Type: -

Identifier Source: org_study_id

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