Actively Recruiting

Age: 18Years +
All Genders
NCT07573371

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

119 weeks

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

The goal of this observational study is to learn why some patients develop low anterior resection syndrome (LARS) after colorectal cancer treatment. The study also aims to identify different subtypes of LARS and understand which patients may respond to specific treatments. The main questions it aims to answer are: * What physiological and imaging changes are associated with LARS? * How do patients with LARS differ from patients without LARS after colorectal cancer surgery? * Are there measurable differences between LARS, patients treated with organ-preserving chemoradiotherapy, and patients with fecal incontinence? Participants will: * Complete advanced physiological and imaging assessments related to bowel function * Be compared with four control groups: * patients without LARS after colorectal cancer surgery * patients treated with organ-preserving chemoradiotherapy * patients with fecal incontinence and urge fecal incontinence * Take part in a single study visit where all measurements are performed

CONDITIONS

Official Title

Understanding and Tailored Treatment of Low Anterior Resection Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must be able to read and understand Danish.
  • Adults older than 18 years with full legal capacity.
  • Able to understand the research protocol, comply with procedures, attend hospital visits, and complete the trial.
  • Patients with rectal cancer operated with rectal resection and sphincter preserving surgery at least 3 months after surgery.
  • If having a temporary protective ileostomy, it must have been reversed for at least 3 months.
  • Patients planned for neuromodulation with satisfactory test results leading to permanent pacemaker implantation for sacral nerve modulation.
  • Rectum/colon cancer patients treated with organ-preserving chemoradiotherapy showing complete response at least 12 months posttreatment.
Not Eligible

You will not qualify if you...

  • Unable to understand 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).
  • Non-removable piercings before MRI.
  • Claustrophobia.
  • Latex allergy.
  • Abdominal diameter 140 cm or more.
  • Any other physician-determined contraindications.
  • Participation in another clinical trial.
  • Known intestinal obstruction, significant strictures, or perforation.
  • Disorders of swallowing.
  • Pregnant women.
  • History of anastomotic leakage after rectal resection surgery.
  • Evidence of local cancer recurrence or spread.

AI-Screening

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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

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Research Team

E

Esben B Mark, PhD

CONTACT

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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