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Understanding and Tailored Treatment of Low Anterior Resection Syndrome

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

• 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.

• Patients planned for neuromodulation.

• Satisfactory interoperative test results leading to permanent implantation of a pacemaker for sacral nerve modulation.

⁃ • 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.

Locations
Other Locations
Denmark
Aalborg University Hospital
ACTIVE_NOT_RECRUITING
Aalborg
Aarhus University Hospital
RECRUITING
Aarhus
Vejle Hospital
RECRUITING
Vejle
Contact Information
Primary
Esben B Mark, PhD
e.mark@rn.dk
97663523
Time Frame
Start Date: 2024-09-17
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 145
Treatments
LARS, minor or major symptoms
LARS score ≥ 20; Patients operated for rectal cancer with a rectal resection and sphincter preserving surgery at a minimum of three months postoperative.~If patients have received a temporary protective ileostomy, this should have been reversed for a minimum of three months postoperative.
LARS, no symptoms
LARS score \< 20; Patients operated for rectal cancer with a rectal resection and sphincter preserving surgery at a minimum of three months postoperative.~If patients have received a temporary protective ileostomy, this should have been reversed for a minimum of three months postoperative.
Faecal Incontinence
* Patients planned for neuromodulation~* Satisfactory interoperative test results leading to permanent implantation of a pacemaker for sacral nerve modulation
Faecal Incontinence, urge
* Patients planned for neuromodulation~* Satisfactory interoperative test results leading to permanent implantation of a pacemaker for sacral nerve modulation~* Faecal urgency occurring ≥3 episodes per week, with or without associated Faecal incontinence (≥1 episode per week), and a St. Mark's Incontinence Score of ≥9
Watch and wait
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
Related Therapeutic Areas
Sponsors
Collaborators: Danish Cancer Society, Vejle Hospital, Aarhus University Hospital
Leads: Aalborg University Hospital

This content was sourced from clinicaltrials.gov