Understanding and Tailored Treatment of Low Anterior Resection Syndrome (NCT07573371) | Clinical Trial Compass
RecruitingNot Applicable
Understanding and Tailored Treatment of Low Anterior Resection Syndrome
Denmark145 participantsStarted 2024-09-17
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 modulatio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.