Personalized Care Pathways for Bowel Symptoms in Rectal Cancer Patients_contributing Factors (Treatable)
NCT ID: NCT06914245
Last Updated: 2026-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
150 participants
INTERVENTIONAL
2025-04-28
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of this study is to identify the factors contributing to persistent bowel symptoms and their long-term impact on quality of life following treatment for rectal cancer, assessed 12 months after surgery or stoma closure in surgically treated patients, and 12 months after completion of neoadjuvant therapy in patients managed with active surveillance/watch-and-wait. These insights are crucial for developing an effective care approach, as they help determine when specific evaluations should be conducted and which treatments should be applied at different stages.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life
NCT06059170
Feasibility Bowel Dysfunction Program After Low Anterior Resection
NCT04733794
Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance
NCT06936774
Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS
NCT04896879
Transanal Irrigation for the Management of LARS
NCT05007015
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TME/PME
To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants scheduled for rectal surgery will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (prior to surgery, and at 1, 6, and 12 months post-rectal surgery or post-stoma closure).
Electronic bowel diary
This bowel diary will be available on the smartphone in the form of an application.
Faecal Incontinence Quality of Life questionnaire (FIQL)
This questionnaire will be available online.
EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)
This questionnaire will be available online.
Active surveillance
To investigate the prognostic variables of persistent bowel symptoms and persistent consequences of bowel symptoms, specifically the impact on QoL, participants in active surveillance will be asked to complete an electronic bowel diary on their mobile phones and to fill out several online questionnaires at multiple time points (at baseline and at 1, 6, and 12 months after completion of neoadjuvant therapy).
Electronic bowel diary
This bowel diary will be available on the smartphone in the form of an application.
Faecal Incontinence Quality of Life questionnaire (FIQL)
This questionnaire will be available online.
EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)
This questionnaire will be available online.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Electronic bowel diary
This bowel diary will be available on the smartphone in the form of an application.
Faecal Incontinence Quality of Life questionnaire (FIQL)
This questionnaire will be available online.
EuroQoL 5 dimensions, 5 levels (EQ-5D-5L)
This questionnaire will be available online.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least 18 years of age at the time of signing the Informed Consent Form (ICF).
* Proficient in reading, comprehending, and conversing in Dutch.
* Patients scheduled for Total Mesorectal Excision (TME) or Partial Mesorectal Excision (PME) or 'Watch and wait' protocol due to rectal cancer.
Exclusion Criteria
* Experienced fecal incontinence prior to undergoing surgery.
* Are affected by neurological disorders affecting bowel function.
* Already underwent previous pelvic radiation or rectal surgery for non-cancer reasons.
* Has a permanent stoma.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AZ Delta
OTHER
Universitair Ziekenhuis Brussel
OTHER
Ziekenhuis aan de Stroom
OTHER
AZ Oostende
UNKNOWN
General Hospital Groeninge
OTHER
Heilig Hart Ziekenhuis Lier
UNKNOWN
Meander MC, Amersfoort, the Netherlands
UNKNOWN
AZORG
UNKNOWN
UZ Leuven, Leuven, Belgium
UNKNOWN
KU Leuven
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Inge Geraerts
Professor Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Inge Geraerts, PhD
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UZ Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
S69283
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.