CholecystolithiasisPhase 4NCT00562900
Robotic Assisted Versus Laparoscopic Cholecystectomy - Outcome and Cost Analyses of a Case-Matched Control Study
A Phase 4 study testing robotic assisted cholecystectomy and Laparoscopic cholecystectomy in people with Cholecystolithiasis, run by University of Zurich at 1 site in Switzerland.
Trial summary
Case matched study on 50 consecutive patients undergoing robotic assisted cholecystectomy (Da Vinci Robot, Intuitive Surgical). These patients are matched 1:1 to 50 patients with conventional laparoscopic cholecystectomy, according to age, gender, ASA score, histology and surgical experience. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystolithiasis
- What is being tested?
- robotic assisted cholecystectomy and Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2004to Feb 2007
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cholecystectomy due to symptomatic cholecystolithiasis
- Acute or chronic cholecystitis
Who cannot join
- Patients < 18 years
- Primary open cholecystectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic Assisted Versus Laparoscopic Cholecystectomy -
Case matched study on 50 consecutive patients undergoing robotic assisted cholecystectomy (Da Vinci Robot, Intuitive Surgical). These patients are matched 1:1 to 50 patients with conventional laparoscopic cholecystectomy, according to age, gender, ASA score, histology and surgical experience.
- Trial with surgical intervention
Read the detailed description
Cholecystectomy is used as a starting procedure for robotic-assisted technology in general surgery by most centers. Surprisingly, data is lacking regarding patient outcome or associated costs compared to the use of conventional laparoscopic surgery.
The study is designed to assess the potential benefits of robotic-assisted cholecystectomy. To achieve a high level of evidence we chose a prospective case matched controlled methodology. Three experienced and one junior (2nd yr) surgeon are involved, and were fully trained with the robot prior to initiating the study including tasks in a training box on pig livers and 5 cholecystectomies performed on humans with this technology. Each patient operated with the robotic system is retrospectively matched one by one with patients who underwent a laparoscopic cholecystectomy.
The robotic assisted operations are performed with the 3- arm Da Vinci robot system (Da Vinci Robot, Intuitive Surgical). Similar to the laparoscopic technique an additional fourth trocar was used to retract the gallbladder. The positioning (French) of the patients and the trocars are also comparable to the conventional laparoscopic cholecystectomy.
- Conditions
- Cholecystolithiasis
- Being tested
- robotic assisted cholecystectomy, Laparoscopic cholecystectomy
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic assisted cholecystectomyProcedure or surgery
robotic assisted cholecystectomy
Laparoscopic cholecystectomyProcedure or surgery
Laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| A, robotic | Active comparator | Not described Receives: Procedure: robotic assisted cholecystectomy |
| B, laparoscopic | Active comparator | Not described Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications
Measured: Dec 04 - Feb 06
Secondary outcomes (1)
Conversion rates, operative time, hospital-costs
Measured: Dec 2004 - Feb 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2007 (estimated)
- Study startDec 2004
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholecystolithiasisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- stefan breitenstein, MD, Principal investigator, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00562900
- Sponsor's protocol ID
- BrS_10-07
- Other IDs
- BrS_10-07
- Status last verified
- Nov 2007
- First submitted
- 7 Nov 2007
- Last updated
- 26 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Breitenstein S, Nocito A, Puhan M, Held U, Weber M, Clavien PA. Robotic-assisted versus laparoscopic cholecystectomy: outcome and cost analyses of a case-matched control study. Ann Surg. 2008 Jun;247(6):987-93. doi: 10.1097/SLA.0b013e318172501f.
PubMed 18520226
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Assisted Versus Laparoscopic Cholecystectomy -
- ClinicalTrials.gov ID
- NCT00562900
- Acronym / sponsor ID
- BrS_10-07
- Conditions
- Cholecystolithiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2004
- Study completion
- Feb 2007 (actual)
- First posted
- 26 Nov 2007 (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.
Case matched study on 50 consecutive patients undergoing robotic assisted cholecystectomy (Da Vinci Robot, Intuitive Surgical). These patients are matched 1:1 to 50 patients with conventional laparoscopic cholecystectomy, according to age, gender, ASA score, histology and surgical experience.
- Trial with surgical intervention
Detailed description
Cholecystectomy is used as a starting procedure for robotic-assisted technology in general surgery by most centers. Surprisingly, data is lacking regarding patient outcome or associated costs compared to the use of conventional laparoscopic surgery.
The study is designed to assess the potential benefits of robotic-assisted cholecystectomy. To achieve a high level of evidence we chose a prospective case matched controlled methodology. Three experienced and one junior (2nd yr) surgeon are involved, and were fully trained with the robot prior to initiating the study including tasks in a training box on pig livers and 5 cholecystectomies performed on humans with this technology. Each patient operated with the robotic system is retrospectively matched one by one with patients who underwent a laparoscopic cholecystectomy.
The robotic assisted operations are performed with the 3- arm Da Vinci robot system (Da Vinci Robot, Intuitive Surgical). Similar to the laparoscopic technique an additional fourth trocar was used to retract the gallbladder. The positioning (French) of the patients and the trocars are also comparable to the conventional laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, robotic | Active comparator | Procedure: robotic assisted cholecystectomy |
| B, laparoscopic | Active comparator | Procedure: Laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cholecystectomy due to symptomatic cholecystolithiasis
- Acute or chronic cholecystitis
Key exclusion criteria (2 listed)
- Patients < 18 years
- Primary open cholecystectomy
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 |
|---|---|---|
| robotic assisted cholecystectomyrobotic assisted cholecystectomy | Procedure or surgery | A, robotic |
| Laparoscopic cholecystectomyLaparoscopic cholecystectomy | Procedure or surgery | B, laparoscopic |
Primary outcome
complications
Time frame: Dec 04 - Feb 06
1 secondary outcome
Conversion rates, operative time, hospital-costs
Time frame: Dec 2004 - Feb 2006
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 26 Nov 2007.
- Derived from this study: PubMed 18520226Breitenstein S, Nocito A, Puhan M, Held U, Weber M, Clavien PA. Robotic-assisted versus laparoscopic cholecystectomy: outcome and cost analyses of a case-matched control study. Ann Surg. 2008 Jun;247(6):987-93. doi: 10.1097/SLA.0b013e318172501f.
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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.
stefan breitenstein, MD principal investigator
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing robotic assisted cholecystectomy and Laparoscopic cholecystectomy in people with Cholecystolithiasis, run by University of Zurich 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 2 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 26 Nov 2007. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
complications (time frame: Dec 04 - Feb 06). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00562900, which also lists 1 linked publication.
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 26 Nov 2007.