Nanoscope System During Sacrospinofixation (SF-CAM)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Sacrospinofixation

Treatments: Device: visualization of the sacrospinous ligament

Study type: Observational

Funder types: Other

Identifiers

NCT06177340

23-5408

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

5 participants in 1 patient group

Sacrospinofixation

Description:

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

Treatment:

Device: visualization of the sacrospinous ligament