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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01078025
Acronym
NOBACT
Enrollment
30
Registered
2010-03-02
Start date
2010-02-28
Completion date
2010-11-30
Last updated
2010-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystectomy

Keywords

transvaginal access for cholecystectomy

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.

Interventions

PROCEDURESmear test vaginally, intraabdominally

Pre- and intraoperative smear tests of the vagina and douglas are performed.

Sponsors

Cantonal Hospital of St. Gallen
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Microbial colonisation and contamination vaginally and intraabdominally1 day

Secondary

MeasureTime frame
Morbidity (wound, vaginal and intraabdominal infection) two weeks and six weeks postoperatively6 weeks

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026