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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
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3-dimensional visualization | Diagnostic Test | Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operating Time | total operating time | 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Major Complication | Number of Participants with Intraoperative Complications | 180 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emre Gorgun, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3D Visualization | 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. 3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode |
| FG001 | 2D Visualization | 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. 2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3D Visualization | 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. 3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Operating Time | total operating time | Posted | Mean | Standard Deviation | minutes | 180 minutes |
|
The standard post-operative period of 30 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3D Visualization | 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. 3-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-operative ileus | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emre Gorgun | Cleveland Clinic | 216 444-1244 | GORGUNE@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 6, 2017 | Sep 8, 2020 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 9, 2018 | Sep 8, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 2-dimensional visualization | Diagnostic Test | Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode |
|
| BG001 | 2D Visualization | 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. 2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | 53 subjects total were included in analysis | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Average BMI | Mean | Standard Deviation | kg/m^2 |
|
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| Secondary | Major Complication | Number of Participants with Intraoperative Complications | Posted | Count of Participants | Participants | 180 minutes |
|
|
|
| 0 |
| 27 |
| 8 |
| 27 |
| 0 |
| 27 |
| EG001 | 2D Visualization | 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. 2-dimensional visualization: Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode | 0 | 26 | 7 | 26 | 0 | 26 |
| Wound Dehiscence | Surgical and medical procedures | Non-systematic Assessment |
|
| Portal vein thrombosis/Deep vein thrombosis | Surgical and medical procedures | Non-systematic Assessment |
|
| Surgical Site Infection | Surgical and medical procedures | Non-systematic Assessment |
|
| Readmission | Surgical and medical procedures | Non-systematic Assessment |
|
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |