Tailored treatment approaches for low anterior resection syndrome
Understanding and Tailored Treatment of Low Anterior Resection Syndrome
This study will see if advanced physiological and imaging tests can identify different subtypes of LARS in people after rectal cancer surgery to help match them to better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 145 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Aalborg and 2 other locations) |
| Trial ID | NCT07573371 on ClinicalTrials.gov |
What this trial studies
This is an observational study using a single in-person visit to perform advanced physiological and imaging assessments of bowel function in people with LARS and several comparison groups. Researchers will enroll about 50 patients with minor or major LARS after rectal cancer surgery and compare their results with patients who had rectal surgery without LARS, patients treated with organ-preserving chemoradiotherapy, and patients with fecal incontinence undergoing neuromodulation. The study aims to define measurable physiological and imaging differences that characterize distinct LARS subtypes and to link those subtypes to likely treatment responses. Findings are intended to inform more targeted, mechanism-based treatment strategies for patients with post-surgical bowel dysfunction.
Who should consider this trial
Good fit: Adults (>18) who can read Danish and are at least three months after sphincter-preserving rectal resection (or meet the specific criteria for the fecal incontinence or watch-and-wait comparison groups) are eligible to participate.
Not a fit: Patients whose symptoms stem from non-surgical causes, who cannot complete the advanced testing, or who do not fit the defined comparison groups are unlikely to gain direct benefit from this observational protocol.
Why it matters
Potential benefit: If successful, the findings could help clinicians match patients to more appropriate, targeted treatments and improve bowel symptoms and quality of life.
How similar studies have performed: Previous work has shown benefit from interventions like neuromodulation and rehabilitation for fecal incontinence and LARS, but using comprehensive physiological and imaging profiling to define subtypes for tailored treatment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aalborg and 2 other locations
- Aalborg University Hospital — Aalborg, Denmark (Active_not_recruiting)
- Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Vejle Hospital — Vejle, Denmark (Recruiting)
Study contacts
- Principal investigator: Peter Christensen, MD, Professor — Pelvic Floor Unit, Department of Surgery, Aarhus University Hospital
- Study coordinator: Esben B Mark, PhD
- Email: e.mark@rn.dk
- Phone: 97663523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.