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

September 22, 2023 updated by: GIHeelkunde, University Hospital, Ghent
Quality of life and risk factors for developing major LARS are explored. Therapeutic options were explored in the cohort experiencing major LARS

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • low anterior resection for rectal cancer between 2006-2016
  • Adults

Exclusion Criteria:

  • abdomino perineal resection
  • patients who do not understand Dutch

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: QOL, risk factor and therapeutic options
questionnaires
Behavioral: LARS score/ EORTC QLQ C30
administering questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment QoL
Time Frame: up to 10 years after rectal resection
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
Time Frame: up to 10 years after rectal resection
Self developed questionaire to determine what therapeutic options were used to manage LARS
up to 10 years after rectal resection
Frequency of LARS
Time Frame: up to 10 years after rectal resection
Assessment of LARS using validated LARS Score
up to 10 years after rectal resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Piet pattyn, MD, University Hospital, Ghent

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

May 2, 2019

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/0180

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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