International Low Anterior Resection Score Evaluation | NCT04040842

Studies
International Low Anterior Resection Score Evaluation

NCT04040842

Sponsor

National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

Status

Unknown status

Last Update Posted

Nov 9, 2023Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Low Anterior Resection Syndrome

Interventions

Patients undergoing low anterior resection

Countries

Lithuania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2019Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jul 28, 2019

First Submission Date that Met QC Criteria

Jul 31, 2019

First Posted Date

Aug 1, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2023

Last Update Posted Date

Nov 9, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Audrius Dulskas, Assoc. professor, National Cancer Center Affiliate of Vilnius University Hospital Santaros KlinikosPrincipal Investigator

Lead Sponsor

National Cancer Center Affiliate of Vilnius University Hospital Santaros KlinikosOTHER

Collaborators

Name	Class
King's College London	OTHER
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patients undergoing low anterior resection	Diagnostic Test	Patients before the surgery and one year after the surgery will be assessed with questionnaire.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Audrius Dulskas, MD, PhD	Contact	867520094		audrius.dulskas@gmail.com
Povilas Kavaliauskas, MD	Contact			povilaskava@gmail.com

Overall Officials

Name	Affiliation	Role
Joseph Nunoo-Mensah, MD	King's College	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Institute	Recruiting	Vilnius		08406	Lithuania

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000094123	Low Anterior Resection Syndrome
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

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Browse Branches

Not provided