Actively Recruiting
Understanding and Tailored Treatment of Low Anterior Resection Syndrome
Led by Aalborg University Hospital · Updated on 2026-05-07
145
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Aalborg University Hospital
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating why some patients develop low anterior resection syndrome (LARS) after treatment for colorectal cancer. LARS is a common long-term complication causing symptoms like urgency, frequent bowel movements, and fecal incontinence, which can greatly affect quality of life. The study aims to understand the underlying physiological and imaging changes associated with LARS, identify different patient subtypes, and compare LARS patients to others treated with organ-preserving chemoradiotherapy or those with fecal incontinence. This observational study includes 50 patients with minor or major LARS after rectal cancer surgery and compares them with four control groups: patients without LARS after surgery, patients with fecal incontinence (before and after nerve stimulation), patients with urge fecal incontinence (before and after nerve stimulation), and patients treated with organ-preserving chemoradiotherapy. All participants attend a single study visit involving advanced physiological measurements, MRI-based assessments, and questionnaires. Patients with LARS will also be followed during their usual stepwise treatment pathway including dietary advice, medication, pelvic floor training, and rectal emptying techniques. During the study visit, participants undergo detailed assessments of bowel function, sensory and motility changes, and sphincter activity. Questionnaires are completed before and during treatment steps to track symptoms and quality of life. Researchers measure outcomes such as quality of life scores, LARS severity, incontinence scores, stool form, anxiety and depression levels, and physiological parameters. This study helps explore how different bowel function patterns relate to treatment response, with the entire process conducted in collaboration among specialized hospitals and research centers.
CONDITIONS
Brief Title
Understanding and Tailored Treatment of Low Anterior Resection Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be able to read and understand Danish
- Adults aged over 18 years with full legal capacity
- Able to comply with study procedures and attend scheduled visits
- Patients with rectal cancer operated with sphincter-preserving surgery at least 3 months postoperative
- If a temporary protective ileostomy was performed, it must have been reversed for at least 3 months
- Patients planned for neuromodulation with satisfactory test results for permanent sacral nerve modulation pacemaker implantation
- Rectum/colon cancer patients treated with organ-preserving chemotherapy and radiotherapy with complete clinical and radiological response at least 12 months posttreatment
You will not qualify if you...
- Unable to understand study information
- Connective tissue disorders
- Parkinson's disease
- Non-MRI compatible pacemaker, clips, or metal objects (patients with sacral nerve modulation pacemaker will not have postoperative MRI)
- Piercings that cannot be removed before MRI
- Claustrophobia
- Allergy to latex
- Abdominal diameter equal to or greater than 140 cm
- Other medical factors making participation unsafe as judged by a physician
- Participation in another clinical trial
- Known intestinal obstruction, significant strictures, or perforation
- Swallowing disorders
- Pregnancy
- History of anastomotic leakage after rectal resection (for LARS patients)
- Evidence of local cancer recurrence or spread (for LARS patients)
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 - 1 day
Participants attend a single study visit that includes advanced physiological measurements, MRI-based assessments, and standardized questionnaires to explore mechanisms behind Low Anterior Resection Syndrome and related conditions.
1 visit (in-person)
Duration - Up to 4 weeks
Participants with Low Anterior Resection Syndrome are followed during their standard stepwise treatment pathway, completing questionnaires before and during each treatment step to assess treatment response.
Multiple visits depending on treatment steps
Trial Site Locations
Total: 3 locations
1
Aalborg University Hospital
Aalborg, Denmark, 9220
Active, Not Recruiting
2
Aarhus University Hospital
Aarhus, Denmark, 8200
Actively Recruiting
3
Vejle Hospital
Vejle, Denmark, 7100
Actively Recruiting
Research Team
E
Esben B Mark, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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