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

Completed

• Conditions: Cholecystectomy
• Interventions: Procedure: Smear test vaginally, intraabdominally

• Registration Number: NCT01078025
• Lead Sponsor: Cantonal Hospital of St. Gallen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Status Verified: 2010-07
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2010-12-09
• Last Update Posted: 2010-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
transvaginal hybrid cholecystectomy	Smear test vaginally, intraabdominally	-
laparoscopic cholecystectomy	Smear test vaginally, intraabdominally	-

Primary Outcome Measures

Name	Time	Method
Microbial colonisation and contamination vaginally and intraabdominally	1 day

Secondary Outcome Measures

Name	Time	Method
Morbidity (wound, vaginal and intraabdominal infection) two weeks and six weeks postoperatively	6 weeks

Trial Locations

Locations (1)

Department of Surgery; 🇨🇭 St.Gallen, Switzerland