AMBULAPSE STUDY Feasibility Study on Laparoscopic Double-mesh Sacrocolpopexy With or Without Robotic Assistance, in Female Patients Presenting With Symptomatic Pelvic Organ Prolapse, Based on an Outpatient Treatment Model.
Recruiting
N/A
Interventional Study
Pelvic Organ Prolapse
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 40 – 80
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- Centre Hospitalier Universitaire de Nice · Other
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About This Trial
Pelvic organ prolapse is an increasingly common functional disorder which affects approximately 30 to 40% of the female population, 12% of whom have a symptomatic form, with a psychological, physical and social impact. Laparoscopic sacrocolpopexy represents the surgical "gold standard" for the treatment of this functional disorder. It aims to suspend the vaginal vault by means of a prosthesis. The…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* woman between 40 and 80 years old
* Patient with significant prolapse POP-Q ≥ 2
* BMI \<30
* ASA score ≤ 2
* sterile ECBU
Exclusion Criteria:
* Criteria related to the pathology or the organ:
* History of pelvic cancer surgery
* History of prolapse surgery
* History o…
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