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Clinical Trials/NCT06177340
NCT06177340
Recruiting
Not Applicable

Visualization by the Nanoscope System During Sacrospinofixation

Hospices Civils de Lyon1 site in 1 country5 target enrollmentJanuary 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sacrospinofixation
Sponsor
Hospices Civils de Lyon
Enrollment
5
Locations
1
Primary Endpoint
visualization of the sacrospinous ligament
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Sacrospinofixation is one of the reference techniques for the treatment of vaginal prolapse. It consists of fixing a non-absorbable thread on the sacrosciatic ligament unilaterally or bilaterally to correct a urogenital prolapse.

The technical difficulty is linked to the fact that the approach to the sacrosciatic ligament is palpatory without visual control. However, if the thread is not well fixed in the ligament, there is a risk of this suture coming loose and therefore of recurrence of the prolapse. On the other hand, due to the vascular and nervous proximity (pudendal nerve), vascular complications such as hemorrhage and/or hematoma have been described by vascular lesion during the passage of the needle through this ligament. Nervous complications due to pinning of the pudendal nerve or its nerve branches have also been described, which can cause after-effects of pain or even chronic dyspareunia.

Clearly and precisely visualizing the sacrosciatic ligament and the vascular and nervous structures with a microcamera could make it possible to better correct the prolapse and limit recurrences, but also to avoid these serious and disabling complications.

The Nanoscope system, which can be used in routine practice as part of sacrospinofixation, could make it possible to obtain visibility of tissues under vision control. Thus the precise visualization of the sacrospinous ligament would allow an easier approach and therefore more precise surgical procedures.

Registry
clinicaltrials.gov
Start Date
January 10, 2024
End Date
April 28, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • women over 18
  • patient who benefited from anterior and/or posterior sacrospinofixation using the nanoscope system
  • person having expressed his non-opposition

Exclusion Criteria

  • inability to understand the information given
  • person deprived of liberty
  • person under guardianship

Outcomes

Primary Outcomes

visualization of the sacrospinous ligament

Time Frame: during surgery

Obtaining visualization of the sacrospinous ligament by the Nanoscope system during sacrospinofixation (binary criterion: yes/no)

Study Sites (1)

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