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 now · Not applicable
Conditions studied: Pelvic Organ Prolapse
In brief
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 exception of the publication by Sinhal which involved 111 patients.
Key facts
- Study ID
- NCT03764852
- Run by
- Centre Hospitalier Universitaire de Nice
- People needed
- 80
- Starts
- 2019-12-14
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-12-04
Who can join
Age: 40 and older, up to 80. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- woman between 40 and 80 years old
- Patient with significant prolapse POP-Q ≥ 2
- BMI <30
- ASA score ≤ 2
- sterile ECBU
You may not qualify if…
- Criteria related to the pathology or the organ:
- History of pelvic cancer surgery
- History of prolapse surgery
- History of pelvic irradiation
- Laying a concomitant urethral strip
- Cervico-vaginal smear test not up to date.
- Patient pregnant or having a desire for pregnancy
- Criteria related to concomitant treatments:
- Cefazoline allergy
- Taking the following medications within 48 hours
- Plavix®
- Vitamin K / Low Molecular Weight Healing Heparin
- Contraindication to ambulatory care for medical reasons
- Sleep apnea syndrome
- Cardiopulmonary pathology
- Psychiatric pathology
- Hemorrhagic risk
- Diabetes imbalanced
- Unbalanced Hypertension
Where it is running
- Hopital Antoine Beclere - Aphp — Clamart, France (enrolling)
- Chu de Nantes — Nantes, France (enrolling)
- CHU DE Nice - Hôpital l'Archet — Nice, France (enrolling)
- Ch Lyon Sud — Pierre-Bénite, France (enrolling)
- Hopital Foch — Suresnes, France (enrolling)
Full record on ClinicalTrials.gov
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