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

Primary Purpose

Faecal Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Sacral neuromodulation in conventional implantation technique
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Faecal Incontinence

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Conventional lead placement

Arm Description

The cadaver is placed in the prone position. The exact location for insertion of the needle is defined with the conventional technique.

Outcomes

Primary Outcome Measures

Distance lead to nerve
The exact distance (mm) will be assessed from the lead to the nerve

Secondary Outcome Measures

Neuroforamen
The inserted neuroforamen will be assessed.
Sacral fascia
A perforation throw the sacral fascia will be noted.

Full Information

First Posted
January 23, 2021
Last Updated
August 1, 2021
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT04726904
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
August 15, 2021 (Anticipated)
Study Completion Date
August 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Faecal Incontinence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional lead placement
Arm Type
Other
Arm Description
The cadaver is placed in the prone position. The exact location for insertion of the needle is defined with the conventional technique.
Intervention Type
Procedure
Intervention Name(s)
Sacral neuromodulation in conventional implantation technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Distance lead to nerve
Description
The exact distance (mm) will be assessed from the lead to the nerve
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Neuroforamen
Description
The inserted neuroforamen will be assessed.
Time Frame
1 week
Title
Sacral fascia
Description
A perforation throw the sacral fascia will be noted.
Time Frame
1 week

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Dawoud, MD
Phone
0043660 280 48 39
Email
christopher.dawoud@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Dawoud, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Dawoud, MD
Email
christopher.dawoud@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33211205
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.
Results Reference
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Best Surgical Technique for Optimal Lead Placement in Sacral Neuromodulation - a Comparative Cadaver Study

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