Status:
COMPLETED
Assessment of Changes in Vaginal Microbiota Profiles Before and After Vaginal Urogynecologic Surgery
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Collaborating Sponsors:
Nantes University Hospital
Conditions:
Gynecological Surgery
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Several studies have shown interactions between vaginal microbiota and post-surgical evolution. A study conducted by our team showed a tendency for patients with complications to have a greater divers...
Detailed Description
In gynecological surgery, surgical site infections are a common complication. Gynecological surgery and, more specifically, vaginal surgery leads to a high risk of infection not only due to its " clea...
Eligibility Criteria
Inclusion
- All Caucasian menopausal women (not taking hormone substitutes)
- Due to undergo transvaginal surgery (as a cure for pelvic organ prolapse or stress urinary incontinence surgery) from the Gynecology departments of Nantes and Nîmes University Hospitals.
- Patients must be covered by a health insurance policy
- Patients must have given written, informed consent.
Exclusion
- Patients on recent (\<1 month) immunosuppressive therapy,
- Patients with ongoing antibiotic therapy,
- Patients with chronic vaginosis,
- Patients on hormone replacement therapy
- Patients who have had previous transvaginal mesh surgery.
- Patients taking part in another category 1 study for research involving human subjects.
- Patients in an exclusion period determined by another study
- Patients under court custody, guardianship or curatorship
- Patients for whom it has been impossible to give clear information
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04301401
Start Date
March 1 2020
End Date
October 10 2023
Last Update
November 18 2023
Active Locations (1)
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1
Centre Hospitalier Universitaire
Nîmes, Gard, France, 30000