Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study
1 other identifier
interventional
5
1 country
1
Brief Summary
Sacral neuromodulation (SNM) is an established treatment option for patients with faecal incontinence. The location of the stimulating electrode is considered to be essential for treatment success. The purpose of this study was to evaluate the position of SNM electrodes after using the conventional implantation technique and to compare our results with those of the preliminary study, where the standardised fluoroscopy-guided implantation technique was used. In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens. After electrode placement the pelvis was dissected to describe the exact position of the SNM electrodes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2020
CompletedFirst Submitted
Initial submission to the registry
January 23, 2021
CompletedFirst Posted
Study publicly available on registry
January 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2021
CompletedAugust 3, 2021
August 1, 2021
8 months
January 23, 2021
August 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Distance lead to nerve
The exact distance (mm) will be assessed from the lead to the nerve
1 week
Secondary Outcomes (2)
Neuroforamen
1 week
Sacral fascia
1 week
Study Arms (1)
Conventional lead placement
OTHERThe cadaver is placed in the prone position. The exact location for insertion of the needle is defined with the conventional technique.
Interventions
Sacral neuromodulation is implanted with the patients in a prone position, then the insert point of the needle is decided according to anatomical landmarks; afterwards, the lead will be inserted.
Eligibility Criteria
You may qualify if:
- Cadaver study
- All of these individuals had donated their bodies to medical education and research in form of an informed consent.
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
Related Publications (1)
Muller C, Reissig LF, Argeny S, Weninger WJ, Riss S. Standardized fluoroscopy-guided implantation technique enables optimal electrode placement in sacral neuromodulation: a cadaver study. Tech Coloproctol. 2021 Feb;25(2):215-221. doi: 10.1007/s10151-020-02364-w. Epub 2020 Nov 19.
PMID: 33211205BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Dawoud, MD
Medical University of Vienna
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.med.univ.
Study Record Dates
First Submitted
January 23, 2021
First Posted
January 27, 2021
Study Start
December 17, 2020
Primary Completion
August 15, 2021
Study Completion
August 15, 2021
Last Updated
August 3, 2021
Record last verified: 2021-08