Actively Recruiting
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
Led by University Hospital, Antwerp · Updated on 2026-01-14
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the occurrence and progression of bowel function problems known as Low Anterior Resection Syndrome (LARS) in adults undergoing surgery for rectal cancer. The study aims to understand how different pre-surgery treatments, types of surgery, and follow-up therapies affect these bowel issues and their impact on work ability. This prospective interventional study will include patients regardless of whether they receive pre-surgery chemotherapy or radiation, with data collected over several years. Participants will be grouped based on whether they have rectal surgery alone or receive additional chemotherapy or radiation before surgery. They will complete online questionnaires at various times before and after surgery, assessing bowel function, quality of defecation, work incapacity, and treatment for LARS. The study will track these outcomes for up to two years after surgery or stoma reversal, with interim analyses planned after two years of patient inclusion. During the study, participants will regularly provide information through automated online questionnaires about their bowel symptoms and daily functioning. Researchers will analyze changes in specific bowel function scores, such as the COREFO and LARS scores, over time compared to baseline. They will also monitor treatments started for LARS and assess quality of life and work ability. The total follow-up period for each participant is two years after their surgery or stoma reversal.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Diagnosed with rectal cancer and planned for sphincter-preserving total or partial mesorectal excision
- Eligible regardless of whether neoadjuvant (pre-surgery) treatment is given
You will not qualify if you...
- History of inflammatory bowel disease such as Crohn's disease or ulcerative colitis
- Dementia or intellectual disability
- Current bowel obstruction requiring decompressive stoma or rectal stenting due to lack of baseline data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months from baseline
Participants complete questionnaires about colorectal function and LARS scores at diagnosis and after neo-adjuvant therapy if applicable.
Questionnaires at diagnosis, after neo-adjuvant therapy, and prior to surgery if delayed
Duration - Up to 1 month post-surgery
Participants undergo rectal surgery and initial recovery.
1 surgical procedure and post-operative assessments
Duration - 2 years after rectal surgery or stoma reversal
Participants complete follow-up questionnaires assessing LARS and colorectal function at multiple time points after surgery.
Questionnaires at 1 month, 3 months, 6 months, 1 year, and 2 years post-surgery
Trial Site Locations
Total: 1 location
1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
Research Team
N
Niels Komen, MD PhD
J
Juul Meurs, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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