Informations générales (source: ClinicalTrials.gov)
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. (AMBULAPSE)
Interventional
N/A
Centre Hospitalier Universitaire de Nice (Voir sur ClinicalTrials)
décembre 2019
décembre 2024
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | PIERRE-OLIVIER BOSSET | 05/05/2025 07:12:02 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Antoine Béclère | Xavier DEFFIEUX, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Ch Lyon Sud - 69310 - Pierre-Bénite - France | Alain RUFFION, MD, PhD | Contact (sur clinicalTrials) | |||
| CHU DE Nice - Hôpital l'Archet - 06200 - Nice - France | Maxence DOREZ, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Chu de Nantes - 44093 - Nantes - France | Marie-Aimée PERROUIN-VERBE, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- woman between 40 and 80 years old
- Patient with significant prolapse POP-Q ≥ 2
- BMI <30
- ASA score ≤ 2
- sterile ECBU
- woman between 40 and 80 years old
- Patient with significant prolapse POP-Q ≥ 2
- BMI <30
- ASA score ≤ 2
- sterile ECBU
- 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