Rectal Cancer Survivorship: Impact of Low Anterior Resect... | NCT06059170

Studies
Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life

NCT06059170

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Sep 28, 2023Actual

Enrollment

187Actual

Phase

Not Applicable

Conditions

Rectal Cancer
Low Anterior Resection Syndrome

Interventions

LARS score/ EORTC QLQ C30

Countries

Belgium

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2017Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

May 2, 2019

First Submission Date that Met QC Criteria

Sep 22, 2023

First Posted Date

Sep 28, 2023Actual

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

Sep 22, 2023

Last Update Posted Date

Sep 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

GIHeelkunde, Clinical nurse specialist digestive oncology, University Hospital, GhentPrincipal Investigator

Lead Sponsor

University Hospital, GhentOTHER

Collaborators

Not provided

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

Quality of life and risk factors for developing major LARS are explored. Therapeutic options were explored in the cohort experiencing major LARS

Detailed Description

Quality of life and risk factors for developing major LARS are explored using the EORTC QLQ C30. Therapeutic options were explored in the cohort experiencing major LARS

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

187Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
QOL, risk factor and therapeutic options	Other	questionnaires	Behavioral: LARS score/ EORTC QLQ C30

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LARS score/ EORTC QLQ C30	Behavioral	administering questionnaire	QOL, risk factor and therapeutic options

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment QoL	Assessments using questionnaire European Organization for Research and Treatment for Cancer Quality of Life Questionnaire (EORTC QLQ C30)	up to 10 years after rectal resection
frequencies of therapeutic options to manage LARS	Self developed questionaire to determine what therapeutic options were used to manage LARS	up to 10 years after rectal resection
Frequency of LARS	Assessment of LARS using validated LARS Score	up to 10 years after rectal resection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

low anterior resection for rectal cancer between 2006-2016
Adults

Exclusion Criteria:

abdomino perineal resection
patients who do not understand Dutch

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Piet pattyn, MD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University hospital Ghent		Ghent	Oost-Vlaanderen	9000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Description

all data are anonymous. only the treating physician has access to the details of the eligible patients

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms
D000094123	Low Anterior Resection Syndrome

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided