Status:
RECRUITING
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.
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
40-80 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
In our study, the investigators propose to evaluate the success rate for outpatient laparoscopic sacrocolpopexy with or without robotic assistance in screened patients. With this aim in mind, the inve...
Eligibility Criteria
Inclusion
- woman between 40 and 80 years old
- Patient with significant prolapse POP-Q ≥ 2
- BMI \<30
- ASA score ≤ 2
- sterile ECBU
Exclusion
- 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
Key Trial Info
Start Date :
December 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03764852
Start Date
December 14 2019
End Date
December 1 2026
Last Update
December 4 2025
Active Locations (5)
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1
Hopital Antoine Beclere - Aphp
Clamart, France, 92140
2
Chu de Nantes
Nantes, France, 44093
3
CHU DE Nice - Hôpital l'Archet
Nice, France, 06200
4
Ch Lyon Sud
Pierre-Bénite, France, 69310