Assessment of Changes in Vaginal Microbiota Profiles Before and After Vaginal Urogynecologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Classes of vaginal flora before surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Patients being evaluated for changes in microbiota
Patients being evaluated for changes in vaginal microbiota following transvaginal surgery.
干预措施: Vaginal swabs (Other)
Patients being evaluated for changes in microbiota
Patients being evaluated for changes in vaginal microbiota following transvaginal surgery.
干预措施: Stool samples (Other)
Patients being evaluated for changes in microbiota
Patients being evaluated for changes in vaginal microbiota following transvaginal surgery.
干预措施: Urine samples (Other)
结局指标
主要结局
Classes of vaginal flora before surgery
时间窗: Day 1
A vaginal swab will be taken before surgery and the sample will be analyzed by DNA sequencing in order to classify the microbiota into community state types.
Classes of vaginal flora 6 weeks after surgery
时间窗: Day 42
A vaginal swab will be taken 6 weeks after surgery and the sample will be analyzed by DNA sequencing in order to classify the microbiota into community state types.
次要结局
- Betadiversity of vaginal flora directly after disinfection and draping, measured with the Bray-Curtis index(Day 1)
- Betadiversity of vaginal flora six weeks after surgery, measured with the Bray-Curtis index(Day 42)
- Pain 12 months after surgery(Month 12)
- Betadiversity of vaginal flora before preparation for surgery measured with the Bray-Curtis index(Day 1)
- Alphadiversity of vaginal flora one hour after disinfection and draping, measured with the Shannon index(Day 1)
- Betadiversity of vaginal flora one hour after disinfection and draping, measured with the Bray-Curtis index(Day 1)
- Prolapse. Feeling a bulge six weeks after surgery(Day 42)
- Urinary incontinence upon effort 12 months after surgery(Month 12)
- Need to urinate urgently six weeks after surgery(Day 42)
- Dysuria 6 weeks after surgery(Day 42)
- Classes of vaginal flora 12 mois after surgery(Month 12)
- Alphadiversity of vaginal flora twelve months after surgery, measured with the Shannon index(Month 12)
- Betadiversity of vaginal flora twelve months after surgery, measured with the Bray-Curtis index(Month 12)
- Dyspareunia 12 months after surgery(Month 12)
- Anal incontinence 6 weeks after surgery(Day 42)
- Presence or absence of complications 6 weeks after surgery(Day 42)
- Urine sample 12 months after surgery(Month 12)
- Alphadiversity of vaginal flora before preparation for surgery measured with the Shannon index(Day 1)
- Alphadiversity of vaginal flora directly after disinfection and draping, measured with the Shannon index(Day 1)
- Alphadiversity of vaginal flora six weeks after surgery, measured with the Shannon index(Day 42)
- Prolapse. Feeling a bulge twelve months after surgery(Month 12)
- Dyspareunia six weeks after surgery(Day 42)
- Pain six weeks after surgery(Day 42)
- Urinary incontinence upon effort six weeks after surgery(Day 42)
- Presence or absence of infection at the operating site 6 weeks after surgery(Day 42)
- Urine sample before surgery(Day 1)
- Need to urinate urgently 12 months after surgery(Month 12)
- Dysuria 12 months after surgery(Month 12)
- Constipation 6 weeks after surgery(Day 42)
- Constipation 12 months after surgery(Month 12)
- Anal incontinence 12 months after surgery(Month 12)
- Presence or absence of complications related to a prosthesis 6 weeks after surgery(Day 42)
- Presence or absence of complications related to a prosthesis 12 months after surgery(Month 12)
- Presence or absence of infection at the operating site 12 months after surgery(Month 12)
- Urine sample after vaginal disinfection and surgical draping.(Day 1)
- Urine sample 6 weeks after surgery six weeks after surgery(Day 42)
- Presence or absence of complications 12 months after surgery(Month 12)
- Stool sample before surgery(Day 0)
- Stool sample 6 weeks after surgery(Day 42)