Why do some cancer survivors struggle with bowel control? new study aims to find out.
NCT ID NCT07573371
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at why some people who had surgery for colorectal cancer develop lasting bowel issues like urgency or leakage. Researchers will compare 145 participants with and without these problems using advanced tests. The goal is to identify different types of bowel dysfunction and figure out which treatments might work best for each type.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 145 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
During outpatient visits, the treatment responsible doctor will identify eligible patients. Patients will be recruited at the following departments: 1. LARS patients - patient operated for rectal cancer at Department of Surgery, Aarhus University Hospital, with rectal resection with sphincter preservation and primary anastomosis. 2. Watch and wait patients - patient treated for rectal cancer with organ preservation at Aalborg University Hospital or Vejle Hospital. 3. Patients with Faecal Incontinence planned for neuromodulation at Pelvic Floor Unit, Department of Surgery, AUH.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Aalborg University Hospital
ACTIVE_NOT_RECRUITINGAalborg, 9220, Denmark
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Aarhus University Hospital
RECRUITINGAarhus, 8200, Denmark
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Vejle Hospital
RECRUITINGVejle, 7100, Denmark
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