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

NCT ID: NCT01078025

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-11-30

Brief Summary

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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

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Conditions

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Cholecystectomy

Keywords

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transvaginal access for cholecystectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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transvaginal hybrid cholecystectomy

Smear test vaginally, intraabdominally

Intervention Type PROCEDURE

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

laparoscopic cholecystectomy

Smear test vaginally, intraabdominally

Intervention Type PROCEDURE

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

Interventions

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Smear test vaginally, intraabdominally

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

Intervention Type PROCEDURE

Smear test vaginally, intraabdominally

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cantonal Hospital of St. Gallen

OTHER

Sponsor Role lead

Responsible Party

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Cantonal Hospital St.Gallen, Departement of Surgery

Principal Investigators

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Andreas Zerz, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital St. Gallen

Locations

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Department of Surgery

Sankt Gallen, St.Gallen, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EKSG09/150/1B

Identifier Type: -

Identifier Source: org_study_id