Nanoscope System During Sacrospinofixation

NCT06177340 | Recruiting

• 1 other identifier: 23-5408
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacrospinofixation

Keywords

Nanoscope system; sacrospinofixation

Outcome Measures

Primary Outcomes (1)

• visualization of the sacrospinous ligament

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

  during surgery

Study Arms (1)

Sacrospinofixation

patient who benefited from anterior and/or posterior sacrospinofixation using the Nanoscope system

Device: visualization of the sacrospinous ligament

Interventions

visualization of the sacrospinous ligament DEVICE

visualization of the sacrospinous ligament by the Nanoscope system during sacrospinofixation

Sacrospinofixation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study concerns patients who underwent anterior and/or posterior sacrospinofixation surgery to correct a prolapse and for whom the Nanoscope system was used.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mère Enfant

Lyon, 69500, France

RECRUITING

Central Study Contacts

Gautier CHENE, MD, PhD

CONTACT

+33 (4) 72 35 58 70; gautier.chene@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: January 10, 2024
• Primary Completion: March 31, 2024
• Study Completion: April 28, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)