Ulcerative Colitis3Dvs2DforUCNCT02370056
Evaluation of 3D Visualization for Total Colectomy
A study testing 3-dimensional visualization and 2-dimensional visualization in people with Ulcerative Colitis, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater accuracy and speed in manual skills, translating to decreased operative time, reduced learning curve, and superior safety.We aimed to determine the feasibility of the laparoscopic approach using 3D visualization in the surgical… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- 3-dimensional visualization and 2-dimensional visualization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 17 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for surgery must be Ulcerative Colitis
- Patient age between 18 and 80
- Elective procedure
- BMI between 17 and 30
- Total colectomy with end ileostomy, without proctectomy
Who cannot join
- Any preoperative diagnosis other than UC
- Patient age< 18, or >80
- Emergency surgery
- Previous gastrointestinal surgery
- BMI>30
- Pregnancy
- Presence of any gastrointestinal tract malignancy
- Segmental colon resections, completion proctectomy, total proctocolectomy, pouch procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Assessment of Three-dimensional vs. Conventional Laparoscopy in a Total Colectomy Model for Ulcerative Colitis
The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater accuracy and speed in manual skills, translating to decreased operative time, reduced learning curve, and superior safety.We aimed to determine the feasibility of the laparoscopic approach using 3D visualization in the surgical treatment of ulcerative colitis
Read the detailed description
Three-dimensional (3D) visualization technology for laparoscopy has been proposed, since the early 1990's, as a method to facilitate laparoscopic performance. However, early 3D laparoscopic technology was limited in terms of image quality, so that its use had not been implemented. The latest technical developments ensure high-definition 3D visualization with the same quality that current two-dimensional (2D) systems provide.
The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater accuracy and speed in manual skills, translating to decreased operative time, reduced learning curve, and superior safety . It was reported that, 3D laparoscopic visualization offers significant advantages in enhancing laparoscopic performance, even in novice surgeons, comparing to the 2D systems . We hypothesize that 3D visualization may allow surgeons to reduce the overall operating time with a rate of 10% with comparable perioperative and postoperative outcomes. The primary endpoint of this study is to determine the feasibility of the laparoscopic approach using 3D visualization in the surgical treatment of ulcerative colitis. Secondary endpoints are to determine whether 3D visualization confers benefits such as reduced operating time and intra-operative complications with comparable postoperative outcomes.
Device Description: The EXERA III Universal Platform will be used in this study, in conjunction with the ENDOEYE FLEX 3D. The ENDOEYE FLEX 3D can also be used in 2D mode, by utilizing a programmed button on the handle of the scope, or by using the 2D/3D button on the 3D Visualization Unit. The articulating tip of the ENDOEYE FLEX allows for the scope to be used in both single-site and multi-port procedures, providing critical views and allowing a bird's eye view so that the scope is out of the way of other instruments (while still capturing the image at the surgical site). All equipment used in this trial has been cleared under 510(k) approval by the FDA, and has been on the market in the US since April 2013.
The Olympus HD 3D Laparoscopic Surgical Video System consists of the following components:
- CV-190 Processor
- CLV-190 Light Source
- 3DV-190 3D Visualization Unit
- LMD-2451MT/3G4 Sony 24" 3D Monitor
- IMH-20 Image Capture System
- UHI-4 Insufflator
- K10021611 Cart
- OL-0015-08 Tall Rollstand
- LTF-190-10-3D ENDOEYE FLEX 3D Videoscope
- 3D glasses (regular and clip-on styles)
Study Size:Mean operating time for laparoscopic subtotal colectomy for medically refractory UC was reported longer with a comparison to open surgery in the recently published studies.
Therefore the effort to decrease operating time in laparoscopic colectomy has gained importance. We assumed that, in order to be able to determine a 10% reduction in mean operating time, each group should include 27 patients (80% power and 5% significance).
Patients who will undergo laparoscopic total abdominal colectomy (TAC) for UC will be included in the study. All subjects will be randomized into two groups: 3D laparoscopy, and 2D laparoscopy. Three staff surgeons (EG, HK, FR) at the department of colorectal surgery, Cleveland Clinic, Ohio will perform the procedures with 2D and 3D laparoscopy. Each surgeon will perform 9 total colectomies with 3D, and 9 total colectomies with the 2D laparoscopy system. In total, 54 patients will be included (27 patients for each group).
- Conditions
- Ulcerative Colitis
- Being tested
- 3-dimensional visualization, 2-dimensional visualization
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-dimensional visualizationDiagnostic test
Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode
2-dimensional visualizationDiagnostic test
Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode
| Study group | Role | What they receive |
|---|---|---|
| 3D Visualization | Experimental | 3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System.
This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated. Receives: Diagnostic Test: 3-dimensional visualization |
| 2D Visualization | Active comparator | 2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System.
This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated. Receives: Diagnostic Test: 2-dimensional visualization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operating Time
total operating time
Measured: 180 minutes
Secondary outcomes (1)
Major Complication
Number of Participants with Intraoperative Complications
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study startMar 2015
- Primary completion17 May 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Gorgun, The Cleveland Clinic
- Investigators
- Emre Gorgun, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370056
- Sponsor's protocol ID
- CCFJJN4
- Acronym
- 3Dvs2DforUC
- Status last verified
- Apr 2021
- First submitted
- 9 Feb 2015
- Last updated
- 12 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Three-dimensional vs. Conventional Laparoscopy in a Total Colectomy Model for Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02370056
- Acronym / sponsor ID
- 3Dvs2DforUC / CCFJJN4
- Conditions
- Ulcerative Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Posted 17 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater accuracy and speed in manual skills, translating to decreased operative time, reduced learning curve, and superior safety.We aimed to determine the feasibility of the laparoscopic approach using 3D visualization in the surgical treatment of ulcerative colitis
Detailed description
Three-dimensional (3D) visualization technology for laparoscopy has been proposed, since the early 1990's, as a method to facilitate laparoscopic performance. However, early 3D laparoscopic technology was limited in terms of image quality, so that its use had not been implemented. The latest technical developments ensure high-definition 3D visualization with the same quality that current two-dimensional (2D) systems provide.
The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater accuracy and speed in manual skills, translating to decreased operative time, reduced learning curve, and superior safety . It was reported that, 3D laparoscopic visualization offers significant advantages in enhancing laparoscopic performance, even in novice surgeons, comparing to the 2D systems . We hypothesize that 3D visualization may allow surgeons to reduce the overall operating time with a rate of 10% with comparable perioperative and postoperative outcomes. The primary endpoint of this study is to determine the feasibility of the laparoscopic approach using 3D visualization in the surgical treatment of ulcerative colitis. Secondary endpoints are to determine whether 3D visualization confers benefits such as reduced operating time and intra-operative complications with comparable postoperative outcomes.
Device Description: The EXERA III Universal Platform will be used in this study, in conjunction with the ENDOEYE FLEX 3D. The ENDOEYE FLEX 3D can also be used in 2D mode, by utilizing a programmed button on the handle of the scope, or by using the 2D/3D button on the 3D Visualization Unit. The articulating tip of the ENDOEYE FLEX allows for the scope to be used in both single-site and multi-port procedures, providing critical views and allowing a bird's eye view so that the scope is out of the way of other instruments (while still capturing the image at the surgical site). All equipment used in this trial has been cleared under 510(k) approval by the FDA, and has been on the market in the US since April 2013.
The Olympus HD 3D Laparoscopic Surgical Video System consists of the following components:
- CV-190 Processor
- CLV-190 Light Source
- 3DV-190 3D Visualization Unit
- LMD-2451MT/3G4 Sony 24" 3D Monitor
- IMH-20 Image Capture System
- UHI-4 Insufflator
- K10021611 Cart
- OL-0015-08 Tall Rollstand
- LTF-190-10-3D ENDOEYE FLEX 3D Videoscope
- 3D glasses (regular and clip-on styles)
Study Size:Mean operating time for laparoscopic subtotal colectomy for medically refractory UC was reported longer with a comparison to open surgery in the recently published studies.
Therefore the effort to decrease operating time in laparoscopic colectomy has gained importance. We assumed that, in order to be able to determine a 10% reduction in mean operating time, each group should include 27 patients (80% power and 5% significance).
Patients who will undergo laparoscopic total abdominal colectomy (TAC) for UC will be included in the study. All subjects will be randomized into two groups: 3D laparoscopy, and 2D laparoscopy. Three staff surgeons (EG, HK, FR) at the department of colorectal surgery, Cleveland Clinic, Ohio will perform the procedures with 2D and 3D laparoscopy. Each surgeon will perform 9 total colectomies with 3D, and 9 total colectomies with the 2D laparoscopy system. In total, 54 patients will be included (27 patients for each group).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D Visualization | Experimental | Diagnostic Test: 3-dimensional visualization3-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using 3D Laparoscopic Surgical Video System. This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons.Effect of using 3D Laparoscopic Surgical Video System on operative outcomes will be evaluated. |
| 2D Visualization | Active comparator | Diagnostic Test: 2-dimensional visualization2-dimensional visualization: In this group, total laparoscopic abdominal colectomy will be performed for patients diagnosed with ulcerative colitis by using conventional Laparoscopic Surgical Video System. This group will be consisted of 27 patients, 9 colectomies performed by 3 surgeons and outcomes will be evaluated. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Indication for surgery must be Ulcerative Colitis
- Patient age between 18 and 80
- Elective procedure
- BMI between 17 and 30
- Total colectomy with end ileostomy, without proctectomy
Key exclusion criteria (8 listed)
- Any preoperative diagnosis other than UC
- Patient age< 18, or >80
- Emergency surgery
- Previous gastrointestinal surgery
- BMI>30
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 |
|---|---|---|
| 3-dimensional visualizationSubjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode | Diagnostic test | 3D Visualization |
| 2-dimensional visualizationSubjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode | Diagnostic test | 2D Visualization |
Primary outcome
Operating Time
Time frame: 180 minutes
total operating time
1 secondary outcome
Major Complication
Time frame: 180 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Emre Gorgun, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-dimensional visualization and 2-dimensional visualization in people with Ulcerative Colitis, run by The Cleveland Clinic at 1 site in United States.
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 5 inclusion and 8 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 12 May 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Operating Time (time frame: 180 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 12 May 2021.