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

Cantonal Hospital of St. Gallen

Status: Completed

Conditions: Cholecystectomy

Treatments: Procedure: Smear test vaginally, intraabdominally

Study type: Observational

Funder types: Other

Identifiers

NCT01078025

EKSG09/150/1B

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

30 participants in 2 patient groups

transvaginal hybrid cholecystectomy

Treatment:

Procedure: Smear test vaginally, intraabdominally

Procedure: Smear test vaginally, intraabdominally

laparoscopic cholecystectomy

Treatment:

Procedure: Smear test vaginally, intraabdominally

Procedure: Smear test vaginally, intraabdominally