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

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

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

Study Overview

• Status: Completed
• Conditions: LAPAROSCOPY; Sacrum; Anomaly
• Intervention / Treatment: Diagnostic test: Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clamart, France
    • Xavier DEFFIEUX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Intraoperative ultrasound; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Xavier DEFFIEUX, AP-HP, Antoine Béclère Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): November 6, 2020
• Study Completion (Actual): November 6, 2020

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 25, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: K160801J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No