Clinical trial NCT04301401: Assessment of Changes in Vaginal Microbiota Profiles Before and After Vaginal Urogynecologic Surgery
Official title: Assessment of Changes in Vaginal Microbiota Profiles Before and After Vaginal Urogynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecological Surgery
Keywords: Microbiota
vagina
prolapse
transvaginal surgery
surgical site infection
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Nantes University Hospital
First posted: 2020-03-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 diversity of vaginal microbiota. The main objective of the proposed study will therefore be to evaluate the vaginal, urinary and digestive microbiota modifications during and after vaginal surgery and to correlate them with the symptoms of the urogynecological sphere.

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 " clean-contaminated " nature related to the proximity of the vagina but also due to the use of a transvaginal mesh or suburetal sling. The germs most commonly found at the origin of a surgical site infection are germs forming part of the vaginal flora.

Furthermore, in the field of pelvic organ prolapse surgery, certain specific complications such as mesh retraction and mesh exposure may be related to infection due to bacterial colonisation.

The vaginal ecosystem contains a large quantity of bacteria, the commonest of which are lactobacilli. This ecosystem varies in women depending on their sexuality, hormonal impregnation, tobacco consumption or hygiene.It has been demonstrated that the microbiota can be divided into 7 classes depending on the predominant types of germ. It has also been shown that an imbalance in vaginal flora could be responsible for infections of the upper genital tract, obstetric complications or even the transmission of sexually transmissible diseases.

Several studies have shown interactions between the microbiota and post surgical evolution. A recent study carried out at the Gynecology and Obstetrics department of Nîmes University Hospital (Veit Rubin et al, NAU 2019) also investigated the relationship between vaginal microbiota and the onset of postoperative complications in transvaginal mesh surgery. This retrospective study also found that patients with complications tended to have a greater diversity of microbiota. Furthermore, certain species of bacteria (Veillonella spp) seemed to be commoner in patients with complications. However, this was a low-powered retrospective study with few participants and the results therefore need to be confirmed.

Our hypothesis is that the vaginal microbiota may be modified by a surgical act with a vaginal approach. There are very few studies on vaginal microbiota and so far no studies have evaluated the potential impact of a transvaginal surgery on vaginal microbiota.

Our study may help to better understand the relationship between the vaginal microbiota and the postoperative evolution of patients.These possible modifications in vaginal microbiota might be predictive of the symptomatology of patients benefitting from transvaginal surgery and play a role in the the post-operative evolution of these patients.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Classes of vaginal flora before surgery
timeFrame: Day 1
measure: Classes of vaginal flora 6 weeks after surgery
timeFrame: Day 42
Secondary outcomes:
measure: Classes of vaginal flora 12 mois after surgery
timeFrame: Month 12
measure: Alphadiversity of vaginal flora before preparation for surgery measured with the Shannon index
timeFrame: Day 1
measure: Betadiversity of vaginal flora before preparation for surgery measured with the Bray-Curtis index
timeFrame: Day 1
measure: Alphadiversity of vaginal flora directly after disinfection and draping, measured with the Shannon index
timeFrame: Day 1
measure: Betadiversity of vaginal flora directly after disinfection and draping, measured with the Bray-Curtis index
timeFrame: Day 1
measure: Alphadiversity of vaginal flora one hour after disinfection and draping, measured with the Shannon index
timeFrame: Day 1
measure: Betadiversity of vaginal flora one hour after disinfection and draping, measured with the Bray-Curtis index
timeFrame: Day 1
measure: Alphadiversity of vaginal flora six weeks after surgery, measured with the Shannon index
timeFrame: Day 42
measure: Betadiversity of vaginal flora six weeks after surgery, measured with the Bray-Curtis index
timeFrame: Day 42
measure: Alphadiversity of vaginal flora twelve months after surgery, measured with the Shannon index
timeFrame: Month 12
measure: Betadiversity of vaginal flora twelve months after surgery, measured with the Bray-Curtis index
timeFrame: Month 12
measure: Prolapse. Feeling a bulge six weeks after surgery
timeFrame: Day 42
measure: Prolapse. Feeling a bulge twelve months after surgery
timeFrame: Month 12
measure: Dyspareunia six weeks after surgery
timeFrame: Day 42
measure: Dyspareunia 12 months after surgery
timeFrame: Month 12
measure: Pain six weeks after surgery
timeFrame: Day 42
measure: Pain 12 months after surgery
timeFrame: Month 12
measure: Urinary incontinence upon effort six weeks after surgery
timeFrame: Day 42
measure: Urinary incontinence upon effort 12 months after surgery
timeFrame: Month 12
measure: Need to urinate urgently six weeks after surgery
timeFrame: Day 42
measure: Need to urinate urgently 12 months after surgery
timeFrame: Month 12
measure: Dysuria 6 weeks after surgery
timeFrame: Day 42
measure: Dysuria 12 months after surgery
timeFrame: Month 12
measure: Constipation 6 weeks after surgery
timeFrame: Day 42
measure: Constipation 12 months after surgery
timeFrame: Month 12
measure: Anal incontinence 6 weeks after surgery
timeFrame: Day 42
measure: Anal incontinence 12 months after surgery
timeFrame: Month 12
measure: Presence or absence of complications 6 weeks after surgery
timeFrame: Day 42
measure: Presence or absence of complications 12 months after surgery
timeFrame: Month 12
measure: Presence or absence of complications related to a prosthesis 6 weeks after surgery
timeFrame: Day 42
measure: Presence or absence of complications related to a prosthesis 12 months after surgery
timeFrame: Month 12
measure: Presence or absence of infection at the operating site 6 weeks after surgery
timeFrame: Day 42
measure: Presence or absence of infection at the operating site 12 months after surgery
timeFrame: Month 12
measure: Urine sample before surgery
timeFrame: Day 1
measure: Urine sample after vaginal disinfection and surgical draping.
timeFrame: Day 1
measure: Urine sample 6 weeks after surgery six weeks after surgery
timeFrame: Day 42
measure: Urine sample 12 months after surgery
timeFrame: Month 12
measure: Stool sample before surgery
timeFrame: Day 0
measure: Stool sample 6 weeks after surgery
timeFrame: Day 42
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire
state: Gard
Study officials:
References: