Evaluation of Intraoperative Ultrasound for the Positioning of Prostheses in Laparoscopic Surgery of Genital Prolapse
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Measure the distance (in mm) between the most distal part of the anterior prosthesis and the bladder neck.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Measure the distance (in mm) between the most distal part of the anterior prosthesis and the bladder neck.
Time Frame: at two months (± 1 month) of follow-up
Comparaison of intraoperative measurement to postoperative measurement
Secondary Outcomes
- Stage of prolapse(until 2 months post-operative)
- Evaluate the symptoms with the PFDI-20 questionnaire(during 2 months post-operative)
- Evaluate patient satisfaction with the PGI-I questionnaire (1-7)(until 2 months post-operative)
- Evaluate the symptoms with the PFIQ-7 questionnaire(during 2 months post-operative)