Sacral Neuromodulation and Faecal Incontinence and Its Unknown Effect on the External Anal Sphincter
NCT ID: NCT06763861
Last Updated: 2025-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
15 participants
OBSERVATIONAL
2024-12-09
2028-12-31
Brief Summary
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SNM is a well implemented treatment for FI and consist of electrical stimulation of sacral nerve roots to promote continence and may even contribute to total continence. It has shown a positive effects on both short- and long-term. The biologic effect of SNM on EAS is unknown.
The aim is to investigate the effect of SNM on EAS morphology, function, and biochemistry to help physicians and researchers to understand the underlying mechanisms of SNM and the anal sphincter complex to further improve and optimize treatment methods for patients with FI.
The research project consists of three phases. The first phase includes biopsies from the EAS among patients with no previous history of FI. These patients have been diagnosed with rectal cancer and will undergo surgery with abdominoperineal excision.
The second phase includes patients diagnosed with FI and subject for implantation of SNM for treatment of FI. Prior to implantation of SNM all patients will have been examined with 3D endo-anal ultrasound and anorectal manometry as well as answered questionnaires targeting general health, bowel dysfunction and FI. A biopsy of the superficial portion of the EAS is retrieved under local anaesthesia in connection to the test period for implantation of the SNM device.
The last phase, phase three, includes 3D endo-anal ultrasound, anorectal manometry, and a second biopsy of the EAS twelve months after implantation with SNM.
The histopathological analysis in all the three phases will include general morphology, distribution of cell nuclei, satellite cells, muscle fiber type, neural structures and connective tissue.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients without diagnosis of FI
Biopsies from EAS among patients diagnosed with rectal cancer and no records of previous diagnosis of FI and now receiving treatment with abdominoperineal resection.
Biopsy
Biopsies from EAS
Patients diagnosed with FI
Biopsies from EAS among patients diagnosed with FI and recieving treatment with sacral neuromodulation before implantation of the device and 12 months postoperatively.
Biopsy
Biopsies from EAS
Interventions
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Biopsy
Biopsies from EAS
Eligibility Criteria
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Inclusion Criteria
* Male or female
* Diagnosed with rectal cancer and receive treatment with abdominoperineal resection
* Signed an informed consent
* Diagnosed with FI and will receive treatment with sacral neuromodulation
* Male or female
* Signed an informed consent
Exclusion Criteria
* Unable to speak and/or read Swedish to ensure informed consent
* Tumour involving the sphincter complex or is in close connection
Phase 2 and 3
* Unable to speak and/or read Swedish to ensure informed consent
18 Years
ALL
No
Sponsors
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Umeå University
OTHER
Responsible Party
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Principal Investigators
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Karin Strigård, Prof., Senior consultant
Role: STUDY_CHAIR
Department of Diagnostics and Interventions, Umeå University
Locations
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Umeå University Hospital
Umeå, Västerbotten County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Karin Strigård, Prof., Senior consultant
Role: primary
Other Identifiers
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Dnr 2024-04527-01
Identifier Type: -
Identifier Source: org_study_id
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