CholelithiasisNCT02396927
3D HD Versus 2D HD in Cholecystectomy
A study testing 3D HD laparoscopy and 2D HD laparoscopy in people with Cholelithiasis and Gall Bladder Disease, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in cholecystectomy in terms of error rating, performance time and subjective assessment. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholelithiasis, Gall Bladder Disease
- What is being tested?
- 3D HD laparoscopy and 2D HD laparoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Sep 2017
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective cholecystectomy (out-patient treatment)
Who cannot join
- Previous upper abdominal surgery
- ASA-score 3 or above
Trial locations and contacts
1 site in 1 country.
Charlotte Fergo contact
Denmark1 site, 1 recruiting
- Recruiting
Herlev Hospital
Herlev, DK2730
Charlotte Fergo, sayakafergo@hotmail.com
About this study
Official title: Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Cholecystectomy: a Clinical Controlled Randomized Double Blinded Trial.
The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in cholecystectomy in terms of error rating, performance time and subjective assessment.
Read the detailed description
Conventional laparoscopy can be very challenging, especially with the requirement of converting the two-dimensional image of the operating field to a three-dimensional perception. This can potentially lead to a detrimental effect on the learning curve as well for the feasibility of the operation for the more inexperienced surgeon. In our hospital, the high frequency of cholecystectomy serves as a basis for the minimally experienced surgeons to explore whether three-dimensional laparoscopy provides a better ability for solving complex intraoperative tasks than the conventional laparoscopy.
- Conditions
- Cholelithiasis, Gall Bladder Disease
- Being tested
- 3D HD laparoscopy, 2D HD laparoscopy
- Keywords
- 3D, Three-dimensional, laparoscopy, cholecystectomy
- Medical subject headings
- Cholelithiasis, Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D HD laparoscopyDevice
Also called Olympus 3D ENDOEYE FLEX
Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.
2D HD laparoscopyDevice
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 2D HD laparoscopy | Placebo comparator | Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode Receives: Device: 2D HD laparoscopy |
| 3D HD laparoscopy | Active comparator | Elective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode Receives: Device: 3D HD laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of errors during the dissection of the Calot´s triangle
The unedited videos of the operations will be assessed according to GERT (Generic Error Rating Tool) by three surgeons, blinded to which optical modalities is used during the operations as done in a previous pilot study.
Measured: Expected duration: 20 minutes
Secondary outcomes (7)
Duration of the dissection of the Calot´s triangle
Measured: Expected duration: 20 minutes
Duration of surgery
Measured: Expected duration: 1 hour
The need for conversion to open surgery
Measured: intraoperative, expected duration of surgery: 1 hour
Estimated blood loss in ml
Measured: intraoperative, expected duration of surgery: 1 hour
Intraoperative complications
e.g. leakage of bile, leakage of gallstone, injury to the bile ducts, injury to organs.
Measured: intraoperative, expected duration of surgery: 1 hour
Subjective assessment (Assessment of fatigue and perceived exertion)
The surgeon will fill out questionnaires and scales.
Measured: an expected average of 15 minutes before and after the operation
Subjective assessment (optical modality and mental load assessment)
The surgeon will fill out questionnaires and scales.
Measured: an expected average of 15 minutes after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charlotte Fergo, Herlev Hospital
- Investigators
- Charlotte Fergo, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396927
- Sponsor's protocol ID
- 3D_vs_2D_chol
- Status last verified
- Feb 2017
- First submitted
- 12 Mar 2015
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Cholecystectomy: a Clinical Controlled Randomized Double Blinded Trial.
- ClinicalTrials.gov ID
- NCT02396927
- Acronym / sponsor ID
- 3D_vs_2D_chol
- Conditions
- Cholelithiasis, Gall Bladder Disease
- Keywords
- 3D, Three-dimensional, laparoscopy, cholecystectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 24 Mar 2015 (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.
The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in cholecystectomy in terms of error rating, performance time and subjective assessment.
Detailed description
Conventional laparoscopy can be very challenging, especially with the requirement of converting the two-dimensional image of the operating field to a three-dimensional perception. This can potentially lead to a detrimental effect on the learning curve as well for the feasibility of the operation for the more inexperienced surgeon. In our hospital, the high frequency of cholecystectomy serves as a basis for the minimally experienced surgeons to explore whether three-dimensional laparoscopy provides a better ability for solving complex intraoperative tasks than the conventional laparoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2D HD laparoscopy | Placebo comparator | Device: 2D HD laparoscopyElective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 2DHD viewing mode |
| 3D HD laparoscopy | Active comparator | Device: 3D HD laparoscopyElective laparoscopic cholecystectomy performed with the use of Olympus ENDOEYE FLEX in the 3DHD viewing mode |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for elective cholecystectomy (out-patient treatment)
Key exclusion criteria (2 listed)
- Previous upper abdominal surgery
- ASA-score 3 or above
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 |
|---|---|---|
| 3D HD laparoscopyAlso: Olympus 3D ENDOEYE FLEXOlympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses. | Device | 3D HD laparoscopy |
| 2D HD laparoscopyPlacebo | Device | 2D HD laparoscopy |
Primary outcome
Number of errors during the dissection of the Calot´s triangle
Time frame: Expected duration: 20 minutes
The unedited videos of the operations will be assessed according to GERT (Generic Error Rating Tool) by three surgeons, blinded to which optical modalities is used during the operations as done in a previous pilot study.
7 secondary outcomes
Duration of the dissection of the Calot´s triangle
Time frame: Expected duration: 20 minutes
Duration of surgery
Time frame: Expected duration: 1 hour
The need for conversion to open surgery
Time frame: intraoperative, expected duration of surgery: 1 hour
Estimated blood loss in ml
Time frame: intraoperative, expected duration of surgery: 1 hour
Intraoperative complications
Time frame: intraoperative, expected duration of surgery: 1 hour
Subjective assessment (Assessment of fatigue and perceived exertion)
Time frame: an expected average of 15 minutes before and after the operation
Subjective assessment (optical modality and mental load assessment)
Time frame: an expected average of 15 minutes after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Charlotte Fergo contact
Charlotte Fergo principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D HD laparoscopy and 2D HD laparoscopy in people with Cholelithiasis and Gall Bladder Disease, run by Herlev Hospital at 1 site in Denmark.
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 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: status not confirmed, as of the sponsor's last update on 28 Feb 2017. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charlotte Fergo (charlotte.sayaka.fergo@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of errors during the dissection of the Calot´s triangle (time frame: Expected duration: 20 minutes). 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 28 Feb 2017.