CholecystolithiasisNCT02357589
3D vs 2D HD Laparoscopy in Cholecystectomy
A study testing 2D laparoscopic cholecystectomy and 3D laparoscopic cholecystectomy in people with Cholecystolithiasis, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The 3D-systems have emerged also to the world of surgery, and the three-dimensional laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholecystolithiasis
- What is being tested?
- 2D laparoscopic cholecystectomy and 3D laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2015to 10 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled for laparoscopic cholecystectomy
Who cannot join
- Some other surgical operation planned during LCC
- Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis, previous cholecystitis)
- Operating surgeon experience less than 5 3D laparoscopy operations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3 Versus 2 Dimensional HD Laparoscopy in Cholecystectomy: a Prospective, Single Blinded, Randomized, Controlled Trial
The 3D-systems have emerged also to the world of surgery, and the three-dimensional laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. Even though the 3D-systems have been widely studied in laboratory circumstances, there are still no evidence of benefits of 3D vs 2D in clinical point of view and no prospective randomized trials have been published. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system for cholecystectomy (LCC).
- Conditions
- Cholecystolithiasis
- Being tested
- 2D laparoscopic cholecystectomy, 3D laparoscopic cholecystectomy
- Keywords
- 3D, laparoscopy, cholecystectomy
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2D laparoscopic cholecystectomyProcedure or surgery
3D laparoscopic cholecystectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 2D laparoscopic cholecystectomy | Active comparator | The normal laparoscopic cholecystectomy with two dimensional view Receives: Procedure: 2D laparoscopic cholecystectomy |
| 3D laparoscopic cholecystectomy | Experimental | The normal laparoscopic cholecystectomy with three dimensional view Receives: Procedure: 3D laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of surgery
Measured: Expected average time of surgery 1 hour
Secondary outcomes (10)
Need for conversion into open surgery
Measured: During the operation, expected average time of surgery 1 hour
Intraoperative complications
Any complication during the operation e.g. hemorrhagic, liver, intestine or gallbladder rupture
Measured: During the operation, expected average time of surgery 1 hour
Complications, Clavien-Dindo classification
Measured: 30 days after randomization
Postoperative stay in hospital
Measured: Expected range 0-7 day
Bleeding
Measured: During the operation, expected average time of surgery 1 hour
Number of participants with readmission(s)
Measured: 30 days after randomization
Total need of opioids in milligrams
Measured: Expected range 0-7 day
Mortality
Measured: 30 days after randomization
Operation theatre time
Measured: Expected average 1,5 hours
Postoperative pain, VAS
Measured: Expected range 0-7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startJan 2015
- Primary completion10 May 2017
- Study completion10 May 2017
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 Helsinki University Central HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanna Koppatz, Helsinki University Central Hospital
- Investigators
- Ville Sallinen, MD, PhD, Study chair, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357589
- Sponsor's protocol ID
- HUCH-328-150127
- Status last verified
- Aug 2017
- First submitted
- 3 Feb 2015
- Last updated
- 29 Aug 2017
- Results posted
- No
Publications
Koppatz H, Harju J, Siren J, Mentula P, Scheinin T, Sallinen V. Three-dimensional versus two-dimensional high-definition laparoscopy in cholecystectomy: a prospective randomized controlled study. Surg Endosc. 2019 Nov;33(11):3725-3731. doi: 10.1007/s00464-019-06666-5. Epub 2019 Feb 1.
PubMed 30710315
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3 Versus 2 Dimensional HD Laparoscopy in Cholecystectomy: a Prospective, Single Blinded, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02357589
- Acronym / sponsor ID
- HUCH-328-150127
- Conditions
- Cholecystolithiasis
- Keywords
- 3D, laparoscopy, cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 6 Feb 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 3D-systems have emerged also to the world of surgery, and the three-dimensional laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. Even though the 3D-systems have been widely studied in laboratory circumstances, there are still no evidence of benefits of 3D vs 2D in clinical point of view and no prospective randomized trials have been published. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system for cholecystectomy (LCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2D laparoscopic cholecystectomy | Active comparator | Procedure: 2D laparoscopic cholecystectomyThe normal laparoscopic cholecystectomy with two dimensional view |
| 3D laparoscopic cholecystectomy | Experimental | Procedure: 3D laparoscopic cholecystectomyThe normal laparoscopic cholecystectomy with three dimensional view |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for laparoscopic cholecystectomy
Key exclusion criteria (3 listed)
- Some other surgical operation planned during LCC
- Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis, previous cholecystitis)
- Operating surgeon experience less than 5 3D laparoscopy operations
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 |
|---|---|---|
| 2D laparoscopic cholecystectomy | Procedure or surgery | 2D laparoscopic cholecystectomy |
| 3D laparoscopic cholecystectomy | Procedure or surgery | 3D laparoscopic cholecystectomy |
Primary outcome
Duration of surgery
Time frame: Expected average time of surgery 1 hour
10 secondary outcomes
Need for conversion into open surgery
Time frame: During the operation, expected average time of surgery 1 hour
Intraoperative complications
Time frame: During the operation, expected average time of surgery 1 hour
Complications, Clavien-Dindo classification
Time frame: 30 days after randomization
Postoperative stay in hospital
Time frame: Expected range 0-7 day
Bleeding
Time frame: During the operation, expected average time of surgery 1 hour
Number of participants with readmission(s)
Time frame: 30 days after randomization
Total need of opioids in milligrams
Time frame: Expected range 0-7 day
Mortality
Time frame: 30 days after randomization
Operation theatre time
Time frame: Expected average 1,5 hours
Postoperative pain, VAS
Time frame: Expected range 0-7 day
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 29 Aug 2017.
- Derived from this study: PubMed 30710315Koppatz H, Harju J, Siren J, Mentula P, Scheinin T, Sallinen V. Three-dimensional versus two-dimensional high-definition laparoscopy in cholecystectomy: a prospective randomized controlled study. Surg Endosc. 2019 Nov;33(11):3725-3731. doi: 10.1007/s00464-019-06666-5. Epub 2019 Feb 1.
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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.
Ville Sallinen, MD, PhD study chair
Helsinki University Central 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 2D laparoscopic cholecystectomy and 3D laparoscopic cholecystectomy in people with Cholecystolithiasis, run by Helsinki University Central Hospital at 1 site in Finland.
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 29 Aug 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 Finland. 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?
Duration of surgery (time frame: Expected average time of surgery 1 hour). 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 NCT02357589, 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 29 Aug 2017.