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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.

NCT03764852 · Centre Hospitalier Universitaire de Nice · Updated 21 Oct 2026

What is being tested
outpatient laparoscopic; outpatient laparoscopic
For
Pelvic Organ Prolapse
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 40 years to 80 years. About 55 people. The full rules are on the registry page.
Where
France (5 sites)
When
Starts or started 14 Dec 2019, ends 28 April 2026. Registered 5 Dec 2018.
Results
None posted yet.

In the researchers' words

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 patient satisfaction rate is evaluated at 94% with low overall complication rate, evaluated at 11%. Pelvic organ prolapse surgery is a common, with an estimated 30,000 procedures carried out in France in 2013 (excluding hysterectomy) (2013 ATIH data), and the number will increase in the future due to increasing life expectancy. 13% of women will undergo this type of procedure. The French General Directorate of Health Care Supply (DGOS) deems outpatient surgery to be the benchmark for surgical activity in all eligible patients, and has expressed the need for recommendations and tools for supporting its development. The rate of outpatient surgery for prolapse remains low in France (6.1%, 2015 ATIH data), while it is 25% in the US and 56% in Denmark. The average duration of hospital stays for DRG N81.2 (first degree uterine prolapse) in 2015 was 3.43 days. These procedures have been the subject of publications concerning outpatient care and involving low numbers of patients, with the…
ClinicalTrials.gov, NCT03764852

Sites

  • Hopital Antoine Beclere - AphpClamart, France
  • Chu de NantesNantes, France
  • CHU DE Nice - Hôpital l'ArchetNice, France
  • Ch Lyon SudPierre-Bénite, France
  • Hopital FochSuresnes, France