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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:
Information provided by:
Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT01078025
First received: March 1, 2010
Last updated: December 9, 2010
Last verified: July 2010
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Morbidity (wound, vaginal and intraabdominal infection) two weeks and six weeks postoperatively [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: March 1, 2010
Last Updated: December 9, 2010
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on November 24, 2014