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

Not Applicable

Completed

• Conditions: LAPAROSCOPY; Sacrum; Anomaly
• Interventions: Diagnostic Test: Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)

• Registration Number: NCT03410303
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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 Timeline

• Study First Submitted: 2017-12-20
• Study Start: 2018-01-15
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-25
• Status Verified: 2020-11
• Primary Completion: 2020-11-06
• Study Completion: 2020-11-06
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative ultrasound	Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)	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.

Primary Outcome Measures

Name	Time	Method
Measure the distance (in mm) between the most distal part of the anterior prosthesis and the bladder neck.	at two months (± 1 month) of follow-up	Comparaison of intraoperative measurement to postoperative measurement

Secondary Outcome Measures

Name	Time	Method
Stage of prolapse	until 2 months post-operative	Evaluate the stage of prolapse on clinical examination according to the International Continence Society (ICS) of Pelvic Organ Prolapse Quantification System (POP-Q) classification (points Ba, Bp, C, D)
Evaluate the symptoms with the PFDI-20 questionnaire	during 2 months post-operative	The Pelvic Floor Disorders Inventory (PFDI-20) score : This is a questionnaire so that patients can answer questions about certain symptoms: intestines, bladder or pelvic
Evaluate patient satisfaction with the PGI-I questionnaire (1-7)	until 2 months post-operative	The Patient Global Impression of Improvement (PGI-I) : The patient should check the box corresponding to the current state of her uro-gynecological problems compared to what they were before treatment
Evaluate the symptoms with the PFIQ-7 questionnaire	during 2 months post-operative	The Pelvic Floor Impact Questionnaire (PFIQ-7) : describe how much les activities, relationships, or feelings have been affected by symptoms bladder, bowel, or vaginal or conditions over.

Trial Locations

Locations (1)

Xavier DEFFIEUX; 🇫🇷 Clamart, France