Per-operative Ultrasonographic Assessement of the Placement of the Mesh in Laparoscopic Sacral Colpo/Hysteropexy (SONOMESH)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: LAPAROSCOPY; Sacrum; Anomaly

Treatments: Diagnostic Test: Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)

Study type: Interventional

Funder types: Other

Identifiers

NCT03410303

K160801J

Details and patient eligibility

About

This study is conducted in order to determinate the faisability of an intraoperative ultrasound to mesure the positioning of prostheses during laparoscopic promontofixation.

Full description

Genital prolapse is a very common functional pathology that affects 30% of women. The functional impact of prolapse is highly variable and may lead patients to consider surgery. Surgery for laparoscopic genital prolapse (laparoscopy) is a common practice. The placement of prostheses on the anterior and posterior walls of the vagina is sort of "estimated", performed without any quality control . This technique is associated with a high rate of patient satisfaction (90% satisfaction), but a risk of anatomical recurrence in 20-30% of cases and a risk of reoperation for relapse in 3% of cases. It is likely that the lower the intervesico-vaginal prosthesis, the lower the risk of cystocele relapse is important.The postoperative ultrasound visualization of prostheses placed in promontofixation is possible: they appear hyperechoic. In particular, in anterior, where a prosthesis is placed between the vagina and the bladder, it is possible to verify that this prosthesis supports the entire bladder base.Thus, it may be possible to check the correct position of the prostheses intraoperatively. If studies were conducted postoperatively, to the best of our knowledge, no study has been conducted on the value of an intraoperative ultrasound control.

Enrollment: 21 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult women (>18 years-old)
• patient who undergo laparoscopic sacral copopexy/hysteropexy
• Affiliation to a public health insurance system
• Written and informed consent given by the patient

Exclusion criteria

• Pregnancy, breast-feading
• woan involved in an interventional research
• Patient under tutorship or curatorship
• Pregnancy and breast feeding

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Intraoperative ultrasound

Other group

Description:

An ultrasound of the position of the prosthesis during surgery, under general anesthesia, is performed. A follow-up visit will be carried out 2 months (± 1 month) after the surgery as part of the usual care. An ultrasound of the position of the prosthesis is performed without anesthesia, either as part of the treatment or as part of the research. This measurement is performed without the intraoperative measurement by an independent sonographer.

Treatment:

Diagnostic Test: Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)