NCT01078025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 10, 2010

Status Verified

July 1, 2010

Enrollment Period

9 months

First QC Date

March 1, 2010

Last Update Submit

December 9, 2010

Conditions

Cholecystectomy

Keywords

transvaginal access for cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Microbial colonisation and contamination vaginally and intraabdominally

    1 day

Secondary Outcomes (1)

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

    6 weeks

Study Arms (2)

transvaginal hybrid cholecystectomy

Procedure: Smear test vaginally, intraabdominally

laparoscopic cholecystectomy

Procedure: Smear test vaginally, intraabdominally

Interventions

Smear test vaginally, intraabdominallyPROCEDURE

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

transvaginal hybrid cholecystectomy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Female patients with symptomatic cholecystolithiasis and given informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy

You may qualify if:

  • indication for elective cholecystectomy
  • informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy

You may not qualify if:

  • cholecystitis
  • intraabdominal infection
  • existing antibiotic therapy
  • adnexitis
  • pelvic inflammatory disease
  • infection (CRP \> 10 mg /l; Lc \> 11 G/l)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery

Sankt Gallen, St.Gallen, 9007, Switzerland

Location

Study Officials

  • Andreas Zerz, MD

    Cantonal Hospital of St. Gallen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2010

First Posted

March 2, 2010

Study Start

February 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

December 10, 2010

Record last verified: 2010-07

Locations

CH(1)