- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01078025
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
St.Gallen, Switzerland, 9007
- Department of Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
transvaginal hybrid cholecystectomy
|
Pre- and intraoperative smear tests of the vagina and douglas are performed.
|
laparoscopic cholecystectomy
|
Pre- and intraoperative smear tests of the vagina and douglas are performed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Microbial colonisation and contamination vaginally and intraabdominally
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Morbidity (wound, vaginal and intraabdominal infection) two weeks and six weeks postoperatively
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EKSG09/150/1B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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