Comparative Assessment of Three-dimensional vs. Conventional Laparoscopy in a Total Colectomy Model for Ulcerative Colitis
Phase: NA
Conditions: Ulcerative Colitis
Sponsor: The Cleveland Clinic

Protocol version date: 11/6/2017 
 
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Comparative Assessment of Three-dimensional vs. Conventional Laparoscopy in a Total 
Colectomy model for Ulcerative Colitis 
Principal Investigator 
Emre Gorgun MD 
Staff, Colorectal Surgery                            
Cleveland Clinic Foundation                                         
E-mail: gorgune@ccf.org  
 
Co- PI’s: 
Hermann Kessler MD 
Staff, Colorectal Surgery                            
Cleveland Clinic Foundation                                         
E-mail: kessleh@ccf.org 
 
Scott R. Steele MD 
Staff, Chairman, Colorectal Surgery                            
Cleveland Clinic Foundation                                         
E-mail: steeles3@ccf.org 
 
Co-Investigator: 
Ipek Sapci MD 
Research Fellow, Colorectal Surgery 
Cleveland Clinic Foundation                                        
E-mail: sapcii@ccf.org 
 
Sponsor Information: 
Olympus Corporation of the Americas (DBA Olympus America Inc.) 
3500 Corporate Parkway 
P.O. Box 610 
Center Valley, PA 18034 

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Introduction 
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 [1]. 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 [2]. It was reported that, 3D laparoscopic visualization 
offers significant advantages in enhancing laparoscopic performance, even in novice 
surgeons, comparing to the 2D systems [3-5]. 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 

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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) 
Materials and Methods 
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 [6, 
7]. 
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, 

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and 2D laparoscopy. Three staff surgeons (EG, HK,SS) at the department of colorectal 
surgery, Cleveland Clinic, Ohio will perform the procedures with 2D and 3D laparoscopy.. In 
total, 54 patients will be included (27 patients for each group). There will be a demonstration 
period in order to increase the surgeon’s familiarity with the new 3D laparoscopy system, and 
each surgeon will perform at least one colectomy procedure before operating on study 
patients. One surgeon (EG) will perform all of his colectomies using a single port approach.  
Two surgeons (HK, SS) will perform all of their colectomies with a multiport approach. 
Inclusion Criteria: 
 Indication for surgery must be Ulcerative Colitis 
 Patient age >18 years of ageElective procedure 
 BMI between ≥ 17 and ≤ 40 
 Total colectomy with end ileostomy, without proctectomy 
Exclusion Criteria: 
 Any preoperative diagnosis other than UC 
 Patient age < 18 years old  
 Emergency surgery 
  (will be adjusted with adhesion scoring.)Pregnancy 
 Presence of any gastrointestinal tract malignancy 
 Segmental colon resections, completion proctectomy, total proctocolectomy, 
pouch procedures 
Baseline data: 
Patient demographics (age, gender, BMI), ASA score, co-morbidities, details of the 
current status of UC (time from diagnosis, medications, presence of dysplasia or malignancy) 
will be documented. 
 

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Adhesion scoring system: 
With the aim of comparability of the groups, a ten-point adhesion scoring system will 
be adopted, modeled from Dowson et al [8]. The extent of adhesions to the incision sites and 
abdominal wall and severity of adhesions will be assessed. Severity of adhesions is classified 
as: grade 0, no adhesions; grade 1, flimsy thickness, avascular; grade 2, moderate thickness, 
limited vascularity; and grade 3, dense thickness, vascularized. The extent of adhesions is 
quantified as: 0, no adhesions; 1, mild (up to 25 per cent of total area and length of incision); 
2, moderate (26–50 per cent of total area and length of incision); and 3, severe (more than 50 
per cent of total area and length of incision).  
Procedural data:  
The procedural data that will be recorded are: name of surgeon, date of surgery, 
operating time, estimated blood loss, number of scope cleaning, number of scope in and out of 
trocar, number of scope fogging, need of conversion, reason for conversion. With the aim of 
underlining the technical impact of using the 3D system, intraoperative inadvertent 
complications such as burns, punctures, and misapplications of the energy device will be 
documented. Total operating time will be defined as period of time from insertion of Veress 
needle to last closure of the skin. Laparoscopic TAC will be evaluated in 5 stages: 
1- Take-down of ileocolic pedicle: Following laparoscopic visualization of the liver 
and the rest of the abdomen to rule out metastatic or other unsuspected disease, the 
colonic dissection will begin with identification and takedown of the ileocolic 
vascular pedicle, which facilitates the exposure and preservation of the underlying 
second and third portions of the duodenum. This stage will start with the incision 
of the peritoneum covering ileocolic pedicle, and end with the completion of the 
ligation of ileocolic artery and vein. 

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2- Mobilization of the right colon: Attachments of the terminal ileum and ascending 
colon will be taken, and hepatic flexure will be mobilized. This stage will start 
after completion of the ileocolic pedicle takedown, and end with full mobilization 
of the hepatic flexure. 
3- Mobilization of the tranverse colon, takedown of the omentum and middle 
colic vessels: Following complete mobilization of the right colon, this stage will 
be started right after taking the right edge of the omentum  down in order to 
mobilization of transvers colon. The first three portions of the duodenum, the head 
of the pancreas, and the right edge of the transverse mesocolon will be identified. 
At this stage, it will be possible to take down the right and left branches of the 
middle colic artery using an energy device or, if necessary, identify and similarly 
take down more proximally the short trunk of the middle colic artery near the 
pancreas. Preservation of the omentum will be left to the discretion of the 
operating surgeon. The takedown of the omentum and transverse mesocolon will 
be continued using a tissue-sealing device from right to left until the splenic 
flexure is reached. 
4- Mobilization of the sigmoid and left colon, and splenic flexure takedown: 
Taking down the splenic flexure by dissection of splenocolic ligament will be 
accepted as the onset time of this stage. Since there will be no oncologic concerns, 
the superior rectal artery will be preserved. The sigmoid colon will be mobilized 
and the sigmoidal arteries will be taken down.  This stage will be completed after 
full mobilization of descending colon and splenic flexure. 
5- Transection of the rectum or rectosigmoid: This stage will start with insertion of 
the stapler through the trocar, and end with rectal or rectosigmoid stump totally 
transected from the colon. 

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6- Identification of the ureters:  Time required for identification of the ureters. 
Time for each stage of the procedure will be documented separately. Postoperative 
complications and length of total hospital stay data will be documented. 
All surgeons involved the study will have a standard eye exam containing visual 
acuity, color vision, stereopsis and accommodation in order to ensure standardization of 
evaluation of surgeon’s visual satisfaction.   To evaluate surgeon’s subjective satisfaction with 
the visualization system, each surgeon will take a survey after completion of surgery. Side 
effects such as color rendition, visual sharpness, contrast, ghosting, eye strain, headache, 
dizziness, disorientation, physical discomfort, and poor visualization will be queried in the 
questionnaire. 
Clinical data obtained from patients will be retained and entered into case report 
forms. These forms  will be maintained on the Department of Colorectal Surgery server. 
Access will be restricted, and accessible by the PI, co-investigators and study coordinator 
approved by this protocol.  
 
Patient Enrollment and Consent 
Patients who are candidates of laparoscopic total colectomy for UC will be given a brief 
presentation and explanation. Printed materials regarding the study, including the Study 
Consent and a written explanation of the two surgical methods, will be provided to the subject 
at that time. 
 It will be made clear to prospective subjects that the purpose of an IRB approved 
study in this setting is to make sure the subjects rights are protected, that the new methods are 
being fairly described and presented, that the potential risks and alternatives are discussed, 
and to gather objective information regarding the two methods, as well as results and 
outcomes. 

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If an eligible patient expresses interest in the study, the Study RN/Coordinator or 
physician will meet/speak with the patient and thoroughly explain both the study and its 
consent form. All subjects will also have the opportunity to further discuss the study with 
their surgeon if they so desire.  After all questions are answered, interested subjects will be 
asked to sign the IRB-approved consent form, at which time they will be enrolled.  It will be 
made clear that in order to enter this study, subjects must be willing to receive either of the 
following procedures:  1) 3D laparoscopic total colectomy 2) 2D laparoscopic total 
colectomy. 
Statistical Analysis 
After obtaining informed consent for each cohort patient enrolled in the study, 2D and 3D 
groups will be constructed by the method of sequential randomization for each surgeon. 
Results will be reported in descriptive statistics and expressed as mean ± SD for continuous 
values. Categorical variables will be analyzed with Chi-square or Fisher exact test, whereas 
Wilcoxon rank sum test will be used for continuous variables. P value < 0.05 will be 
considered significant. 
  
Adverse Events: Definitions and Reporting 
 
Adverse Events (AEs) will be defined as any untoward or unfavorable medical 
occurrence in a human subject, including any abnormal sign, symptom, or disease, temporally 
associated with the subject's participation in the research, whether or not considered related to 
the subject's participation in the research.  
Serious Adverse Events (SAEs) will be defined as any adverse event temporally 
associated with the subject's participation in research that meets any of the following criteria: 
 results in death; 
 is life-threatening; 

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 requires inpatient hospitalization or prolongation of existing hospitalization; 
 results in a persistent or significant disability/incapacity; 
 results in a congenital anomaly/birth defect; or 
 any other adverse event that, based upon appropriate medical judgment,    
 
PI will be responsible for identifying adverse events during the procedure and during 
the standard of care follow-up period. PI will review adverse events experienced by subjects 
treated at the site during the procedure and standard of care follow-up period and will record 
them using the adverse event (AE) Form. PI will review all adverse events, expected or 
unexpected, per standard medical care. PI will classify AEs and SAEs as expected or 
unexpected. AEs and SAEs will be reported directly to the Sponsor and IRB per local IRB 
reporting policy. 
 
Device Observations 
Device observations and/or malfunctions will be documented on case report forms.  In 
the event of a suspected malfunction or device observation, Sponsor shall be contacted 
immediately.  Sponsor will provide instructions to the investigator for returning the device, or 
may go to the site to investigate and resolve the problem. 
Management of Data Collection 
Data Recording and Case Report Forms: 
All data collected under this protocol will be recorded on case report forms (CRFs).  
The CRFs will not include any Patient Identifiers (such as name, date of birth, address, SS 
number, hospital record number, etc.). Instructions for completing the CRFs include: 
All entries on the CRFs will be made legibly in ink.  If corrections are made to entries 
in the CRFs a single stroke will be drawn through them.  The correct data will be inserted and 
the correction will be initialed and dated.  Incorrect entries must not be covered with 

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correcting fluid, or obliterated, or made illegible in any way.  A reasonable explanation must 
be given by the investigators and assistants for all missing data. 
Monitoring Plan: 
The study will be internally monitored for data integrity and accuracy.   The Sponsor 
will have access to any internal monitoring reports generated during the study.  The Sponsor 
will have access to case report forms, log books and signed informed consent forms to enable 
its own monitoring of the study. 
 
Protocol Deviations and Modifications 
No protocol modifications will be implemented prior to Sponsor approval and 
amendment approval from the IRB.  The Sponsor and IRB (including other review boards as 
required for this study) will be notified of any protocol deviations. 
 
Institutional Review Board (IRB) Approval 
The principal investigator is responsible for submitting this protocol, the informed 
consent document, and all relevant supporting data to the IRB or Ethics Committee. IRB 
approval of the protocol, informed consent document, and any advertisement used to recruit 
study subjects must be obtained before the study may be initiated. The principal investigator 
is responsible for keeping the IRB advised of the progress of the study and of any changes 
made to the protocol as deemed appropriate, but in any case, at least once a year.  The 
principal investigator is also responsible for notifying the IRB of any serious adverse events 
that occur during the study. 
 
 
Confidentiality 
To protect subject confidentiality, the subject’s name is not to appear anywhere on the 
CRF’s or other information provided to the sponsor. Each page should be identified with the 

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subject’s case study number, which is comprised of a three-digit number. A Subject Log will 
be maintained by the Investigator to enable tracing of specific case study numbers to subjects.  
 
 
 
References 
1. Kunert W, Storz P, Kirschniak A. For 3D laparoscopy: a step toward advanced surgical 
navigation: how to get maximum benefit from 3D vision. Surg Endosc. 2013 
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2. Tanagho YS, Andriole GL, Paradis AG, Madison KM, Sandhu GS, Varela JE, Benway 
BM. 2D versus 3D visualization: impact on laparoscopic proficiency using the 
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10.1007/s00464-011-2055-9. Epub 2011 Dec 17. 
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Epub 2012 Jan 11. 
5. Votanopoulos K, Brunicardi FC, Thornby J, Bellows CF. Impact of three-dimensional 
vision in laparoscopic training. World J Surg. 2008 Jan;32(1):110-8. 

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6. Telem DA, Vine AJ, Swain G, Divino CM, Salky B, Greenstein AJ, Harris M, Katz LB. 
Laparoscopic subtotal colectomy for medically refractory ulcerative colitis: the time has 
come. Surg Endosc. 2010 Jul;24(7):1616-20. doi: 10.1007/s00464-009-0819-2. Epub 
2010 Mar 5. 
7. Messenger DE1, Mihailovic D, MacRae HM, O'Connor BI, Victor JC, McLeod RS. 
Subtotal colectomy in severe ulcerative and Crohn's colitis: what benefit does the 
laparoscopic approach confer? Dis Colon Rectum. 2014 Dec;57(12):1349-57.