Clinical trial NCT03410303: Per-operative Ultrasonographic Assessement of the Placement of the Mesh in Laparoscopic Sacral Colpo/Hysteropexy
Official title: Evaluation of Intraoperative Ultrasound for the Positioning of Prostheses in Laparoscopic Surgery of Genital Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: LAPAROSCOPY
Sacrum; Anomaly
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure the distance (in mm) between the most distal part of the anterior prosthesis and the bladder neck.
timeFrame: at two months (± 1 month) of follow-up
Secondary outcomes:
measure: Stage of prolapse
timeFrame: until 2 months post-operative
measure: Evaluate the symptoms with the PFDI-20 questionnaire
timeFrame: during 2 months post-operative
measure: Evaluate patient satisfaction with the PGI-I questionnaire (1-7)
timeFrame: until 2 months post-operative
measure: Evaluate the symptoms with the PFIQ-7 questionnaire
timeFrame: during 2 months post-operative
Other outcomes:
Locations:
city: Clamart
country: France
facility: Xavier DEFFIEUX
Study officials:
affiliation: AP-HP, Antoine Béclère Hospital
name: Xavier DEFFIEUX
role: PRINCIPAL_INVESTIGATOR
References: