CholecystolithiasisNCT01056250
SILS Cholecystectomy: Cholangiography of the Biliary Tract
A study testing SILS cholangiography in people with Cholecystolithiasis, run by St John of God Hospital, Vienna at 1 site in Austria.
Trial summary
Single Incision Laparoscopic Surgery (SILS) can be performed for different standard operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy sometimes a cholangiography (marking the biliary tract with contrast agent) is necessary to identify and preserve relevant structures. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cholecystolithiasis
- What is being tested?
- SILS cholangiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2009to Dec 2010
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cholecystolithiasis
Who cannot join
- acute cholecystitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performing Cholangiography During SILS Cholecystectomy: is it Feasible?
Single Incision Laparoscopic Surgery (SILS) can be performed for different standard operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy sometimes a cholangiography (marking the biliary tract with contrast agent) is necessary to identify and preserve relevant structures. The investigators want to evaluate feasibility of performing cholangiography during SILS cholecystectomy.
- Conditions
- Cholecystolithiasis
- Being tested
- SILS cholangiography
- Keywords
- cholelithiasis
- Medical subject headings
- Cholecystolithiasis, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SILS cholangiographyProcedure or surgery
Also called LESS, E-NOTES
intraoperative
| Study group | Role | What they receive |
|---|---|---|
| SILS cholangiography | Other | Performing cholangiography in all patients undergoing SILS cholecystectomy. Receives: Procedure: SILS cholangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of cholangiography during SILS cholecystectomy
Measured: at operation
Secondary outcomes (1)
biliary tract injury
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionNov 2010
- Study completionDec 2010
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St John of God Hospital, Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Bernhard Dauser, MD, Principal investigator, St John of God Hospital, Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056250
- Sponsor's protocol ID
- CT3
- Other IDs
- SJOG 3
- Status last verified
- Jul 2010
- First submitted
- 24 Jan 2010
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performing Cholangiography During SILS Cholecystectomy: is it Feasible?
- ClinicalTrials.gov ID
- NCT01056250
- Acronym / sponsor ID
- CT3
- Conditions
- Cholecystolithiasis
- Keywords
- cholelithiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- St John of God Hospital, ViennaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Jan 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.
Single Incision Laparoscopic Surgery (SILS) can be performed for different standard operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy sometimes a cholangiography (marking the biliary tract with contrast agent) is necessary to identify and preserve relevant structures. The investigators want to evaluate feasibility of performing cholangiography during SILS cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SILS cholangiography | Other | Procedure: SILS cholangiographyPerforming cholangiography in all patients undergoing SILS cholecystectomy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cholecystolithiasis
Key exclusion criteria (1 listed)
- acute cholecystitis
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 |
|---|---|---|
| SILS cholangiographyAlso: LESS, E-NOTESintraoperative | Procedure or surgery | SILS cholangiography |
Primary outcome
Feasibility of cholangiography during SILS cholecystectomy
Time frame: at operation
1 secondary outcome
biliary tract injury
Time frame: 2 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 May 2011.
Related trials for Cholecystolithiasis
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Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
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Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
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Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
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RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
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Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
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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.
Bernhard Dauser, MD principal investigator
St John of God Hospital, Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SILS cholangiography in people with Cholecystolithiasis, run by St John of God Hospital, Vienna at 1 site in Austria.
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 1 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 May 2011. 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 Austria. 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 of cholangiography during SILS cholecystectomy (time frame: at operation). 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 May 2011.