Evaluation of Microbial Colonisation and Contamination Caused by the Transvaginal and Transabdominal Access for Cholecystectomy (NOBACT)
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.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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-
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St.Gallen、瑞士、9007
- Department of Surgery
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- indication for elective cholecystectomy
- informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy
Exclusion Criteria:
- cholecystitis
- intraabdominal infection
- existing antibiotic therapy
- adnexitis
- pelvic inflammatory disease
- infection (CRP > 10 mg /l; Lc > 11 G/l)
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
transvaginal hybrid cholecystectomy
|
Pre- and intraoperative smear tests of the vagina and douglas are performed.
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|
laparoscopic cholecystectomy
|
Pre- and intraoperative smear tests of the vagina and douglas are performed.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Microbial colonisation and contamination vaginally and intraabdominally
大体时间：1 day
|
1 day
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Morbidity (wound, vaginal and intraabdominal infection) two weeks and six weeks postoperatively
大体时间：6 weeks
|
6 weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- EKSG09/150/1B
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