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OpenTrials
Completed

NCT Number: NCT01078025

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

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.

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Key information

Conditions

Cholecystectomy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Surgery

Sankt Gallen, St.Gallen, 9007, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Smear test vaginally, intraabdominally

Procedure

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

Primary outcomes

  1. Microbial colonisation and contamination vaginally and intraabdominally

    Time frame: 1 day

Secondary outcomes

  1. Morbidity (wound, vaginal and intraabdominal infection) two weeks and six weeks postoperatively

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Acronym: NOBACT

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 2, 2010
Registry last updated
Dec 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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