CholecystectomyNOBACTNCT01078025
Evaluation of Microbial Colonisation and Contamination Caused by the Transvaginal and Transabdominal Access for Cholecystectomy
An observational study of Cholecystectomy, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cholecystectomy
- What is being tested?
- Smear test vaginally, intraabdominally
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2010to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients with symptomatic cholecystolithiasis and given informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy
Who may be able to join
- indication for elective cholecystectomy
- informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy
Who cannot join
- cholecystitis
- intraabdominal infection
- existing antibiotic therapy
- adnexitis
- pelvic inflammatory disease
- infection (CRP > 10 mg /l; Lc > 11 G/l)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cholecystectomy
- Being tested
- Smear test vaginally, intraabdominally
- Keywords
- transvaginal access for cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smear test vaginally, intraabdominallyProcedure or surgery
Pre- and intraoperative smear tests of the vagina and douglas are performed.
Smear test vaginally, intraabdominallyProcedure or surgery
Pre- and intraoperative smear tests of the vagina and douglas are performed.
| Study group | Role | What they receive |
|---|---|---|
| transvaginal hybrid cholecystectomy | Not described Receives: Procedure: Smear test vaginally, intraabdominally | |
| laparoscopic cholecystectomy | Not described Receives: Procedure: Smear test vaginally, intraabdominally |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial colonisation and contamination vaginally and intraabdominally
Measured: 1 day
Secondary outcomes (1)
Morbidity (wound, vaginal and intraabdominal infection) two weeks and six weeks postoperatively
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Investigators
- Andreas Zerz, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078025
- Sponsor's protocol ID
- EKSG09/150/1B
- Acronym
- NOBACT
- Status last verified
- Jul 2010
- First submitted
- 1 Mar 2010
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Microbial Colonisation and Contamination Caused by the Transvaginal and Transabdominal Access for Cholecystectomy
- ClinicalTrials.gov ID
- NCT01078025
- Acronym / sponsor ID
- NOBACT / EKSG09/150/1B
- Conditions
- Cholecystectomy
- Keywords
- transvaginal access for cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transvaginal hybrid cholecystectomy | – | Procedure: Smear test vaginally, intraabdominally |
| laparoscopic cholecystectomy | – | Procedure: Smear test vaginally, intraabdominally |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients with symptomatic cholecystolithiasis and given informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy
Key inclusion criteria (2 listed)
- indication for elective cholecystectomy
- informed consent for laparoscopic cholecystectomy or transvaginal hybrid cholecystectomy
Key exclusion criteria (6 listed)
- cholecystitis
- intraabdominal infection
- existing antibiotic therapy
- adnexitis
- pelvic inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smear test vaginally, intraabdominallyPre- and intraoperative smear tests of the vagina and douglas are performed. | Procedure or surgery | transvaginal hybrid cholecystectomy |
| Smear test vaginally, intraabdominallyPre- and intraoperative smear tests of the vagina and douglas are performed. | Procedure or surgery | laparoscopic cholecystectomy |
Primary outcome
Microbial colonisation and contamination vaginally and intraabdominally
Time frame: 1 day
1 secondary outcome
Morbidity (wound, vaginal and intraabdominal infection) two weeks and six weeks postoperatively
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Zerz, MD principal investigator
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystectomy, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial colonisation and contamination vaginally and intraabdominally (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2010.