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

LAPAROSCOPY Clinical Trial

— SONOMESH  

Official title:

Evaluation of Intraoperative Ultrasound for the Positioning of Prostheses in Laparoscopic Surgery of Genital Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410303
• Other study ID #: K160801J
• Status: Completed
• Phase: N/A
• Start date: January 15, 2018
• Est. completion date: November 6, 2020

Study information

• Verified date: November 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• LAPAROSCOPY
• Sacrum; Anomaly

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	Xavier DEFFIEUX	Clamart

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the distance (in mm) between the most distal part of the anterior prosthesis and the bladder neck.	Comparaison of intraoperative measurement to postoperative measurement	at two months (± 1 month) of follow-up
Secondary	Stage of prolapse	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)	until 2 months post-operative
Secondary	Evaluate the symptoms with the PFDI-20 questionnaire	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	during 2 months post-operative
Secondary	Evaluate patient satisfaction with the PGI-I questionnaire (1-7)	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	until 2 months post-operative
Secondary	Evaluate the symptoms with the PFIQ-7 questionnaire	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.	during 2 months post-operative