Long-term follow-up of bowel function (LARS) after rectal cancer surgery and neoadjuvant therapy
Official title: ProLARS Trial: Prospective Longitudinal Follow-up of Low Anterior Resection Syndrome (LARS) and COREFO Score After Rectum Surgery in Patients Undergoing Upfront Surgery or Different Neo-adjuvant Treatment Regimens
Run by University Hospital, Antwerp · NCT07339904 · Data updated 2026-11-12
This project will see how bowel symptoms (LARS) change over time after sphincter-preserving rectal cancer surgery and whether different neoadjuvant treatment schedules affect those symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Status | Recruiting |
| Started | August 26, 2024 |
| Main results expected | August 2029 |
| Study ends | August 2029 |
| Registry record updated | January 14, 2026 |
| Trial ID | NCT07339904 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with rectal adenocarcinoma planned for sphincter-preserving total or partial mesorectal excision, regardless of planned neoadjuvant therapy, are ideal candidates.
✕Probably not a fit
Patients with inflammatory bowel disease, dementia or intellectual disability, or those requiring urgent decompressive stoma or rectal stenting are excluded and unlikely to benefit from this protocol's findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, multicentre interventional follow-up enrolling adults planned for sphincter-preserving total or partial mesorectal excision for rectal cancer. Participants complete standardized questionnaires including LARS and COREFO scores at scheduled intervals to capture symptom incidence and trajectory after surgery and during/after different neoadjuvant and adjuvant regimens. The study will compare symptom evolution across treatment schedules and surgical types, identify risk factors linked to worse functional outcomes, and monitor the impact of LARS on work incapacity. Data collection is questionnaire-driven and used to guide monitoring and potential interventions for LARS.
Why it matters
Potential benefit: If successful, results could help predict which treatments and surgical approaches lead to worse LARS and guide personalized counseling and management to reduce long-term bowel dysfunction.
How similar studies have gone: Prior observational work has described LARS and validated scores like COREFO, but prospective longitudinal comparisons across different neoadjuvant schedules are relatively limited, making this approach somewhat novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older. * Diagnosis of rectal cancer, discussed at the multidisciplinary consultation, with the intention to perform a sphincter preserving total mesorectal excision (TME) or partial mesorectal excision (PME), regardless of the need of neoadjuvant treatment. Exclusion Criteria: * History of inflammatory bowel disease (Crohn's disease, ulcerative colitis) due to often persistent bowel complaints and therefore distorted baseline and follow-up data. * Dementia or intellectual disability. * Patients who are obstructive and in need a decompressive stoma or rectal stenting due to the lack of baseline data as they are often admitted to the hospital in an urgent setting
Where it's running
-
University Hospital Antwerp
Edegem, Antwerp, Belgium Recruiting
Study contacts
- Principal investigator: Niels Komen, MD PhD — University Hospital, Antwerp
- Study coordinator: Niels Komen, MD PhD
- Email: niels.komen@uza.be
- Phone: +32 3 821 30 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.