Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study

Faecal Incontinence Clinical Trial

Official title:

Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04726904
• Other study ID #: 2219/2018
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2020
• Est. completion date: August 15, 2021

Study information

• Verified date: August 2021
• Source: Medical University of Vienna
• Contact: Christopher Dawoud, MD
• Phone: 0043660 280 48 39
• Email: christopher.dawoud[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: August 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cadaver
• Faecal Incontinence
• Fecal Incontinence

Intervention

Procedure:
• Sacral neuromodulation in conventional implantation technique
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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Müller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance lead to nerve	The exact distance (mm) will be assessed from the lead to the nerve	1 week
Secondary	Neuroforamen	The inserted neuroforamen will be assessed.	1 week
Secondary	Sacral fascia	A perforation throw the sacral fascia will be noted.	1 week