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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

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Antwerp
NCT07339904 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

OBJECTIVE Low anterior resection syndrome (LARS) is a term for functional bowel complaints occurring after low anterior resection. Symptoms can range from faecal incontinence and frequent loose stools to urgency and incomplete emptying with great impact on quality of life. Little is known about the longitudinal evolution of LARS and the impact of different schedules of neoadjuvant chemoradiotherapy combined with surgery. The investigators aim to investigate the incidence and evolution of functional bowel complaints in function of different neoadjuvant treatment regimens, type of surgery and adjuvant therapy in patients who undergo surgery for rectal cancer. The investigators focus on following objectives: evolution of LARS- and COREFO-scores per treatment regimen and their impact on work incapacity; identification of possible risk factors potentially related to functional outcome; monit

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📋 Eligibility rules (as published)
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
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What it tests

  • Questionnaire
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Where

1 site
University Hospital Antwerp
Edegem, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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