Feasibility of Outpatient Laparoscopic Surgery for Pelvic Organ Prolapse
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.
This study is testing if women with pelvic organ prolapse can safely have outpatient laparoscopic surgery without needing to stay overnight in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 5 sites (Clamart and 4 other locations) |
| Trial ID | NCT03764852 on ClinicalTrials.gov |
What this trial studies
This study evaluates the success rate of outpatient laparoscopic sacrocolpopexy, with or without robotic assistance, in women suffering from symptomatic pelvic organ prolapse. The study aims to include 80 female patients and will assess whether these procedures can be performed safely without the need for overnight hospitalization. Success is defined by the absence of complications requiring inpatient admission within 24 hours post-surgery. Patients will be monitored for one month post-operation to evaluate the effectiveness of the treatment using established clinical indicators.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 to 80 with significant pelvic organ prolapse and a BMI under 30.
Not a fit: Patients with a history of pelvic cancer surgery, previous prolapse surgery, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more convenient treatment option for women with pelvic organ prolapse.
How similar studies have performed: Previous studies on outpatient laparoscopic procedures have shown high success rates, suggesting a promising outlook for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clamart and 4 other locations
- Hopital Antoine Beclere - Aphp — Clamart, France (Recruiting)
- Chu de Nantes — Nantes, France (Recruiting)
- CHU DE Nice - Hôpital l'Archet — Nice, France (Recruiting)
- Ch Lyon Sud — Pierre-Bénite, France (Recruiting)
- Hopital Foch — Suresnes, France (Recruiting)
Study contacts
- Principal investigator: Brannwel TIBI, MD — Centre Hospitalier Universitaire de Nice
- Study coordinator: Brannwel TIBI, MD
- Email: tibi.b@chu-nice.fr
- Phone: 0492037849
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.