Condition: Rectal Adenocarcinoma · LARS - Low Anterior Resection Syndrome · Rectal Resection · Sponsor: University Hospital, Antwerp
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; monitoring and treatment of LARS. METHODS This will be a multicentre prospective interventional study. The study population will consist of adult patients with rectal cancer, regardless of any neo-adjuvant therapy. Patients will be included for 5 years with a 2 year postoperative follow-up. Interim analysis will be made after 2 years of inclusion. Patients with intellectual disability or clinical colon obstruction are excluded. Automated online questionnaires including LARS and COREFO scores, incapacity for work and defecation quality will be sent at different time points (figure 1) using REDCap. …
This description comes directly from the study's public registry record.
Niels Komen, MD PhD · +32 3 821 30 00 · niels.komen@uza.be
Juul Meurs, MD · +32476617623 · juul.meurs@gmail.com
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| University Hospital Antwerp | Edegem, Antwerp, Belgium | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07339904