Evaluation of Microbial Colonisation and Contamination Caused by the Transvaginal and Transabdominal Access for Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Microbial colonisation and contamination vaginally and intraabdominally
研究概览
简要总结
Transvaginal hybrid procedures are of interest as an available NOTES procedure for the clinical routine. The gynaecologists' experiences and the available studies report on low morbidity related to the transvaginal access. However, little is known about the vaginal and intraabdominal microbial contamination due to the transvaginal approach.
The aim of this cohort study is to evaluate the microbial colonisation and contamination in patients with transvaginal hybrid and conventional laparoscopic cholecystectomy.
Therefore, pre- and intraoperative microbiological evaluations will be performed in patients with transvaginal hybrid cholecystectomy and laparoscopic cholecystectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •indication for elective cholecystectomy
- •informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy
排除标准
- •cholecystitis
- •intraabdominal infection
- •existing antibiotic therapy
- •adnexitis
- •pelvic inflammatory disease
- •infection (CRP > 10 mg /l; Lc > 11 G/l)
结局指标
主要结局
Microbial colonisation and contamination vaginally and intraabdominally
时间窗: 1 day
次要结局
- Morbidity (wound, vaginal and intraabdominal infection) two weeks and six weeks postoperatively(6 weeks)