Last updated: February 6, 2024
Sponsor: Centre Hospitalier Universitaire de Nice
Overall Status: Active - Recruiting
Phase
N/A
Condition
Genitourinary Prolapse
Treatment
outpatient laparoscopic
Clinical Study ID
NCT03764852
18-PP-12
Ages 40-80 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- woman between 40 and 80 years old
- Patient with significant prolapse POP-Q ≥ 2
- BMI <30
- ASA score ≤ 2
- sterile ECBU
Exclusion
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
Study Design
Total Participants: 80
Treatment Group(s): 1
Primary Treatment: outpatient laparoscopic
Phase:
Study Start date:
December 14, 2019
Estimated Completion Date:
December 31, 2024
Study Description
Connect with a study center
Hopital Antoine Beclere - Aphp
Clamart, 92140
FranceActive - Recruiting
Chu de Nantes
Nantes, 44093
FranceActive - Recruiting
CHU DE Nice - Hôpital l'Archet
Nice, 06200
FranceActive - Recruiting
Ch Lyon Sud
Pierre-Bénite, 69310
FranceActive - Recruiting
Hopital Foch
Suresnes, 92150
FranceActive - Recruiting
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