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Completed

NCT Number: NCT03410303

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Xavier DEFFIEUX

Clamart, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)

Diagnostic Test

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 outcomes

  1. 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

  1. Stage of prolapse

    Time frame: 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)

  2. Evaluate the symptoms with the PFDI-20 questionnaire

    Time frame: 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

  3. Evaluate patient satisfaction with the PGI-I questionnaire (1-7)

    Time frame: 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

  4. Evaluate the symptoms with the PFIQ-7 questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: SONOMESH

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 25, 2018
Registry last updated
Nov 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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