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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01078025
First Posted: March 2, 2010
Last Update Posted: December 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cantonal Hospital of St. Gallen
  Purpose

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.


Condition Intervention
Cholecystectomy Procedure: Smear test vaginally, intraabdominally

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by Cantonal Hospital of St. Gallen:

Primary Outcome Measures:
  • Microbial colonisation and contamination vaginally and intraabdominally [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • Morbidity (wound, vaginal and intraabdominal infection) two weeks and six weeks postoperatively [ Time Frame: 6 weeks ]

Estimated Enrollment: 30
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
transvaginal hybrid cholecystectomy Procedure: Smear test vaginally, intraabdominally
Pre- and intraoperative smear tests of the vagina and douglas are performed.
laparoscopic cholecystectomy Procedure: Smear test vaginally, intraabdominally
Pre- and intraoperative smear tests of the vagina and douglas are performed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female patients with symptomatic cholecystolithiasis and given informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078025


Locations
Switzerland
Department of Surgery
St.Gallen, Switzerland, 9007
Sponsors and Collaborators
Cantonal Hospital of St. Gallen
Investigators
Principal Investigator: Andreas Zerz, MD Cantonal Hospital St.Gallen
  More Information

Responsible Party: Andreas Zerz, MD, Cantonal Hospital St.Gallen, Departement of Surgery
ClinicalTrials.gov Identifier: NCT01078025     History of Changes
Other Study ID Numbers: EKSG09/150/1B
First Submitted: March 1, 2010
First Posted: March 2, 2010
Last Update Posted: December 10, 2010
Last Verified: July 2010

Keywords provided by Cantonal Hospital of St. Gallen:
transvaginal access for cholecystectomy