CholecystolithiasisNCT00940264
Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.
An observational study of Cholecystolithiasis and Cholecystitis, run by Ignazio Tarantino at 1 site in Switzerland.
Trial summary
Transvaginal hybrid procedures especially the transvaginal hybrid cholecystectomy are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety in a selected patient collective. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cholecystolithiasis, Cholecystitis
- What is being tested?
- transvaginal hybrid cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2008to Apr 2011
- 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 patiens with given indication for cholcystectomy
Who may be able to join
- given informed consent for transvaginal hybrid cholecystectomy
Who cannot join
- pregnancy
- malignoma
- present choledocholithiasis
Trial locations and contacts
1 site in 1 country.
About this study
Transvaginal hybrid procedures especially the transvaginal hybrid cholecystectomy are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety in a selected patient collective. The aim of this prospective data collection is to evaluate the feasibility in the clinical routine in a non select patient collective.
Therefore all patients giving the informed consent to the transvaginal hybrid cholecystectomy will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.
- Conditions
- Cholecystolithiasis, Cholecystitis
- Being tested
- transvaginal hybrid cholecystectomy
- Keywords
- symptomatic cholecystolithiasis
- Medical subject headings
- Cholecystolithiasis, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal hybrid cholecystectomyProcedure or surgery
transvaginal hybrid cholecystectomy: using one trans-umbilical 5mm trocar and 2 (one 12mm trocar, one 5-mm trocar)inserted through the posterior colpotomy. Removal of the gallbladder through the transvaginal access.
| Study group | Role | What they receive |
|---|---|---|
| Given indication for cholecystectomy | Not described Receives: Procedure: transvaginal hybrid cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and safety of the transvaginal operation
Measured: 30 days
Secondary outcomes (1)
Long-term life quality and sexual dysfunction
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2009 (estimated)
- Study startSep 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystolithiasisStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ignazio Tarantino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ignazio Tarantino, Cantonal Hospital of St. Gallen
- Investigators
- Andreas Zerz, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00940264
- Sponsor's protocol ID
- EKSG08/060/2B
- Status last verified
- Feb 2012
- First submitted
- 14 Jul 2009
- Last updated
- 13 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Transvaginal Hybrid Cholecystectomy: a Prospective Data Collection.
- ClinicalTrials.gov ID
- NCT00940264
- Acronym / sponsor ID
- EKSG08/060/2B
- Conditions
- Cholecystolithiasis, Cholecystitis
- Keywords
- symptomatic cholecystolithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ignazio TarantinoUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 15 Jul 2009 (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 especially the transvaginal hybrid cholecystectomy are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety in a selected patient collective. The aim of this prospective data collection is to evaluate the feasibility in the clinical routine in a non select patient collective.
Therefore all patients giving the informed consent to the transvaginal hybrid cholecystectomy will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Given indication for cholecystectomy | – | Procedure: transvaginal hybrid cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female patiens with given indication for cholcystectomy
Key inclusion criteria (1 listed)
- given informed consent for transvaginal hybrid cholecystectomy
Key exclusion criteria (3 listed)
- pregnancy
- malignoma
- present choledocholithiasis
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 |
|---|---|---|
| transvaginal hybrid cholecystectomytransvaginal hybrid cholecystectomy: using one trans-umbilical 5mm trocar and 2 (one 12mm trocar, one 5-mm trocar)inserted through the posterior colpotomy. Removal of the gallbladder through the transvaginal access. | Procedure or surgery | Given indication for cholecystectomy |
Primary outcome
Feasibility and safety of the transvaginal operation
Time frame: 30 days
1 secondary outcome
Long-term life quality and sexual dysfunction
Time frame: 3 year
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 13 Feb 2012.
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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 Cholecystolithiasis and Cholecystitis, run by Ignazio Tarantino 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 1 inclusion and 3 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 13 Feb 2012. 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?
Feasibility and safety of the transvaginal operation (time frame: 30 days). 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 13 Feb 2012.