NCT03764852 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.
| NCT ID | NCT03764852 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Pelvic Organ Prolapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2019-12-14 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2019-12-14 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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 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
Contact & Investigator
Brannwel TIBI, MD
PRINCIPAL INVESTIGATOR
Centre Hospitalier Universitaire de Nice
Frequently Asked Questions
Who can join the NCT03764852 clinical trial?
This trial is open to female participants only, aged 40 Years or older, up to 80 Years, studying Pelvic Organ Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03764852 currently recruiting?
Yes, NCT03764852 is actively recruiting participants. Contact the research team at tibi.b@chu-nice.fr for enrollment information.
Where is the NCT03764852 trial being conducted?
This trial is being conducted at Clamart, France, Nantes, France, Nice, France, Pierre-Bénite, France and 1 additional location.
Who is sponsoring the NCT03764852 clinical trial?
NCT03764852 is sponsored by Centre Hospitalier Universitaire de Nice. The principal investigator is Brannwel TIBI, MD at Centre Hospitalier Universitaire de Nice. The trial plans to enroll 80 participants.