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.
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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…
Contacts

Brannwel TIBI, MD

0492037849

tibi.b@chu-nice.fr

CONTACT

Matthieu DURAND, MD

0492037849

durand.m@chu-nice.fr

CONTACT