NCT06059170

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2019

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

May 2, 2019

Last Update Submit

September 22, 2023

Conditions

Rectal CancerLow Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

QOL, risk factor and therapeutic options

OTHER

questionnaires

Behavioral: LARS score/ EORTC QLQ C30

Interventions

LARS score/ EORTC QLQ C30BEHAVIORAL

administering questionnaire

QOL, risk factor and therapeutic options

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • abdomino perineal resection
  • patients who do not understand Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Rectal NeoplasmsLow Anterior Resection Syndrome

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesColonic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Piet pattyn, MD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: cross sectional study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical nurse specialist digestive oncology

Study Record Dates

First Submitted

May 2, 2019

First Posted

September 28, 2023

Study Start

March 17, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

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

Locations

BE(1)