Tailored treatment approaches for low anterior resection syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Vejle Hospital
  Vejle, Denmark Recruiting
• Aalborg University Hospital
  Aalborg, Denmark Active not 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.