Nanoscope System During Sacrospinofixation

Last updated: February 27, 2024
Sponsor: Hospices Civils de Lyon
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

visualization of the sacrospinous ligament

Clinical Study ID

NCT06177340
23-5408
  • Ages 18-100
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: visualization of the sacrospinous ligament
Phase:
Study Start date:
January 10, 2024
Estimated Completion Date:
April 28, 2024

Connect with a study center

  • Hôpital Femme Mère Enfant

    Lyon, 69500
    France

    Active - Recruiting

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