NCT07573371 Understanding and Tailored Treatment of Low Anterior Resection Syndrome
| NCT ID | NCT07573371 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aalborg University Hospital |
| Condition | Low Anterior Resection Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 145 participants |
| Start Date | 2024-09-17 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 145 participants in total. It began in 2024-09-17 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: General: * Must be able to read and understand Danish. * All participants must be adults and \>18 years and have full legal capacity. * Assessed by study personnel to have understood the research protocol, being able to comply with investigation procedures as well as ability to come to the hospital at the agreed timepoints, and to complete the trial. Specific inclusion criteria for LARS patients: * Patients operated for rectal cancer with a rectal resection and sphincter preserving surgery at a minimum of three months postop. * If patients have received a temporary protective ileostomy, this should have been reversed for a minimum of three months postop. Specific inclusion criteria for fecal incontinence patients and urge fecal incontinence patients * Patients planned for neuromodulation. * Satisfactory interoperative test results leading to permanent implantation of a pacemaker for sacral nerve modulation. Specific inclusion criteria for "watch and wait" patients: • Rectum/colon cancer patients treated with organ-preserving treatment, i.e., chemotherapy and radiotherapy with a complete clinical and radiological response at a minimum of 12 months posttreatment. Exclusion Criteria: General exclusion criteria * Persons that are not able to understand information * Connective tissue disorders * Parkinson's disease * Non-MRI compatible pacemaker, clips or other metal objects in the body. Patients implanted with a pacemaker for sacral nerve modulation will not undergo MRI postoperatively. * Piercings that cannot be removed before MRI * Claustrophobia * Allergic to latex * Abdominal diameter equal or more than 140 cm * Have other individual factors, in the opinion of the physician/healthcare professional, in which participating is contraindicated * Participation in concomitant clinical trial * Known intestinal obstruction, significant intestinal strictures or perforation. If in doubt about intestinal stricture, the patient will be examined with MRI of the small intestine, colonoscopy or other supplementing examination * Disorders of swallowing * Pregnant women Specific exclusion criterias for LARS patients * History of anastomotic leakage following rectal resection and sphincter preserving therapy * Evidens of local recurrence or dessimination of the cancer
Contact & Investigator
Peter Christensen, MD, Professor
PRINCIPAL INVESTIGATOR
Pelvic Floor Unit, Department of Surgery, Aarhus University Hospital
Frequently Asked Questions
Who can join the NCT07573371 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Low Anterior Resection Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07573371 currently recruiting?
Yes, NCT07573371 is actively recruiting participants. Contact the research team at e.mark@rn.dk for enrollment information.
Where is the NCT07573371 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Vejle, Denmark.
Who is sponsoring the NCT07573371 clinical trial?
NCT07573371 is sponsored by Aalborg University Hospital. The principal investigator is Peter Christensen, MD, Professor at Pelvic Floor Unit, Department of Surgery, Aarhus University Hospital. The trial plans to enroll 145 participants.