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NCT01078025 Clinical Trial

Evaluation of Microbial Colonisation and Contamination Caused by the Transvaginal and Transabdominal Access for Cholecystectomy

Cholecystectomy Clinical Trial

— NOBACT  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01078025
Other study ID # EKSG09/150/1B
Secondary ID
Status Completed
Phase N/A
First received March 1, 2010
Last updated December 9, 2010
Start date February 2010
Est. completion date November 2010

Study information
Verified date July 2010
Source Cantonal Hospital of St. Gallen
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Smear test vaginally, intraabdominally
Pre- and intraoperative smear tests of the vagina and douglas are performed.
• Smear test vaginally, intraabdominally
Pre- and intraoperative smear tests of the vagina and douglas are performed.

Locations
Country Name City State
Switzerland Department of Surgery St.Gallen

Sponsors (1)
Lead Sponsor Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microbial colonisation and contamination vaginally and intraabdominally 1 day No
Secondary Morbidity (wound, vaginal and intraabdominal infection) two weeks and six weeks postoperatively 6 weeks No
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