Clinical trial NCT04726904: Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study
Official title: Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Faecal Incontinence
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: 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.

However, to date no studies exist comparing different surgical techniques. The present cadaver study was designed to assess the distance between lead and sacral nerves by comparing two different surgical techniques: the new fluoroscopy guided "H" technique and the commonly conducted non radiological lead implantation using anatomical landmarks.

In this cadaver study, SNM electrodes will be implanted bilaterally in 5 lower body specimens.Afterwards the cadaver will be dissected and the exact location to the nerve, as well as a perforation of the sacral fascia will be noted.

The results will be compared to the preliminary study of Mueller et al., where they used the new fluoroscopy guided "H" technique in five cadavers.

Eligibility criteria: Inclusion Criteria:

* Cadaver study
* All of these individuals had donated their bodies to medical education and research in form of an informed consent.

Exclusion Criteria:

* none

Primary outcomes:
measure: Distance lead to nerve
timeFrame: 1 week
Secondary outcomes:
measure: Neuroforamen
timeFrame: 1 week
measure: Sacral fascia
timeFrame: 1 week
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Christopher Dawoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.