Comparison of Surgeons' Object Discernment Via Their Hands Versus Using a Robotic Surgical System That Does Not Incorporate Haptics
Conditions: Health Services Research
Sponsor: Valley Health System

 
Culligan 
Comparison of surgeons’ haptics with and without robotics   
v1 06.24.23 
 
 
 
NON-INTERVENTIONAL/METHODOLOGICAL  
RESEARCH PROTOCOL  
 
STUDY INFORMATION 
 
 Title of Project:  
Comparison of surgeons’ object discernment via their hands versus using a robotic 
surgical system that does not incorporate haptics 
 
 Sponsor:  The Valley Hospital 
 
 Principal Investigator    
Patrick Culligan, MD, FACOG, FACS 
 
 Principal Investigator Dept.   
Obstetrics & Gynecology / Urogynecology 
 
 Principal Investigator Contact Info:  
cullpa@valleyhealth.com   
1200 East Ridgewod Ave.   
Suite 205   
Ridgewood, NJ 07450 
 
 Protocol Version and Date:  v1 06.24.23 
 
 
 
 
 
 
 

 
Culligan 
Comparison of surgeons’ haptics with and without robotics   
v1 06.24.23 
 
 
 
1.0 Research Design 
 
1.1 Purpose/Specific Aims  
 
A. Objectives   
The objective of this study is to compare surgeons’ discernment of 4 balloons filled 
with different materials when using their eyes and hands versus using the da Vinci 
robot. 
 
B. Hypotheses / Research Question(s):  
We believe that so called “visual haptics” derived from the high definition 3D optics 
associated with robotic surgery will allow for non-inferior object discernment 
compared to actual haptics of touching objects with surgeons’ hands.  
 
1.2 Research Significance (Briefly describe the following in 500 words or less)   
Robotic surgery has emerged as a transformative technology in the field of medicine, 
revolutionizing surgical procedures across various specialties. The integration of advanced 
robotic systems, such as the da Vinci Surgical Systems, has provided surgeons with enhanced 
precision, improved dexterity, and greater visualization during complex surgical interventions. 
These advancements have been realized despite the lack any haptic feedback to the surgeon 
when using the da Vinci systems.   
Robotic-assisted surgery is typically done through small incisions through which the surgeon 
places access points (ports) which are then connected to the robotic arms.  The robotic arms hold 
the specialized robotic instruments and the high-definition 3D camera.  After setting everything 
up, the surgeon sits at a console near the operating table and views the magnified, high-
resolution 3D image of the surgical site. The surgeon's fingers are inserted into master controls 
on the console, which are designed to mimic the movements of the surgeon's hands. Figure 1 
depicts the most widely used robotic system – the da Vinci System (Intuitive Surgical, 
Sunnyvale CA) versus traditional laparoscopy.  
Haptic feedback (i.e. the sense of touch) helps surgeons perceive the texture, resistance and 
consistency of various tissues and structures. This information helps surgeons maintain the 
optimal force during tissue manipulation. Ever since the first use of the da Vinci system in 1999, 
critics have bemoaned the lack of haptics as the Achilles heel of robotic surgery.   

 
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Comparison of surgeons’ haptics with and without robotics   
v1 06.24.23 
However, experienced robotic surgeons often report that they develop the sense of  “visual 
haptics” that allows them to discern various properties of different tissue types as though they 
could actually feel them simply through a combination of manipulation and visualization.   
To date, no studies have compared surgeons’ ability to discern the nature of objects with their 
hands to robotic surgeons’ ability to discern them while using only the robotic technology. 
 
1.3 Research Design and Methods 
 
A. Research Procedures   
This will be a non-randomized parallel group study in which a group of surgeons 
(Group A) will make determinations as to the material within each of four visually 
identical balloons that contain air, water, petroleum jelly or a firm substance similar 
to the consistency of a non-ripe banana (Figure 2) using their hands and eyes while 
another group of experienced robotic surgeons (Group B) will do so using the da 
Vinci Xi System (Intuitive Surgical, Sunnyvale, CA).  Only Board-certified surgeons 
will be recruited for the study. The study information will be obtained at Valley 
Hospital and the Intuitive Surgical training facility in Atlanta, Georgia.  
Surgeon demographics will be recorded on Case Report Form #1 
Before making their “hands on” determinations as to balloon contents, each surgeon 
will be asked to first determine whether they can visually determine the balloon 
contents without any manipulation.  For the purposes of outcome measurement, only 
two possible outcomes will be considered – namely that the 4 balloons were ordered 
correctly or not.  We will also record each “guess” for all surgeons in order to report 
any trends of mis-assortment that may occur.  
 
B. Duration for Study and Each Subject   
Each study participant will spend about 5 minutes doing study activities.  We estimate 
that we will be finished with data collection by September 1st, 2023 
All data collection will be performed by Dr. Patrick Culligan 
 
1.3 Preliminary Data  
Our balloon model was informally deemed plausible by myself and two other colleagues. 
(Figure 1) 
 
 
 
 
 
 
 

 
Culligan 
Comparison of surgeons’ haptics with and without robotics   
v1 06.24.23 
1.4 Sample Size Justification  
The probability of ordering all balloons correctly by chance is 1/24 or .0417.  
The expectation is that group A will achieve 100% success.  If so, we will require 35 surgeons 
in Group A and 18 surgeons in Group B to achieve 80% power to make the determination that 
Group B was (or was not) “non-inferior” at discerning balloons (alpha = 0.05).  
1.6 Study Variables 
 
A. Independent Variables, Interventions, or Predictor Variables  
  
Primary outcome: (y/n) whether balloons were sorted correctly  
 Secondary outcome: Trends for any mis-assignments of balloons 
 
De-identified surgeon demographics will be compared between groups 
 
 
1.7 Data Collection 
 
A. Primary Data Collection 
 
 Location: The Valley Hospital and Intuitive Surgical Training Center in Atlanta GA. ( 
Permission to conduct study at the Intuitive Surgical site  obtained from Myriam 
Curet, MD , Intuitive Surgical CMO.   
 Process of Data Collection:  Case Report Forms (see attached) will be filled out and 
collected by Dr. Culligan   
 Timing and Frequency: One time only per surgeon.  Data collection will happen in 1 
or 2 days at the Intuitive Surgical site – dates TBD   
 Procedures for Audio/Visual Recording: N/A  
 Study Instruments: The balloon model (Figure 2)  is made of posterboard to which 4 
balloons (Party City gold 5 inch) each containing 20 mL of material – either air, water, 
petroleum jelly, or water-absorbing crystals (LiquiLock, Oatey Inc) are affixed (Figure 
1)  The same model will be used for all data collection if possible, but in the event of 
balloon breakage or some other reason, identical replacement balloons may be created 
easily.  The surgeons will be allowed to manipulate the balloons with their hands 
(Group A) or the robotic instruments (Group B) as they see fit, but they must leave the 
poster board laying flat with the balloons still attached. Surgeon Demographics (de-
identified) and study data will be collected on Case Report forms 1 & 2. (Figures 3 & 
4) 
 Ethnographic Studies, Interviews, Or Observation: Surgeons will be allowed to 
manipulate the balloons as they see fit whether they are using their hands or the 
robotic instruments, but they will not be allowed to disconnect the balloons from the 
poster board.  The poster board must lay flat at all times.   

 
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Comparison of surgeons’ haptics with and without robotics   
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 Subject Identifiers: Dr. Culligan will hold the key indicating which substance is in 
each balloon.  Each surgeon will be assigned a subject number sequentially.  
 
B. Secondary Data Collection  
N/A 
 
1.9 Interviews, Focus Groups, Surveys, and/or Observations  
N/A 
  
 
B. Study Instruments 
 Evaluation Instrument Details – see above.  The case report forms are Figures 3 
& 4 
 
 
2.0 Project Management 
 
2.1 Research Staff and Qualifications   
Dr. Patrick Culligan (CV attached) has extensive clinical research experience and is up to date 
with his CITI training 
 
 
2.2 Research Staff Training – N/A 
 
2.3 Research Sites   
The Valley Hospital & Intuitive Surgical Training Center, Atlanta, GA 
 
 
3.0 Multi Center Research  N/A 
 
4.0 Research Data Source/s 
 
4.1 Subject Selection and Enrollment Considerations  
 
A. Method to Identify Potential Subjects  
For the non-robotic surgeons, we will use any Board Certified surgeons on staff at The 
Valley Hospital.  For the robotic surgeons, we will use any The Valley Hospital surgeons 
with unrestricted robotic privileges or any similarly credentialed robotic surgeons we 
encounter at the Intuitive Surgical Training Center.  
 
 
B. Recruitment Details –  
Dr. Culligan will approach surgeons to ask for their participation and guide them through the 
study process 
C. Subject Screening –  

 
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Comparison of surgeons’ haptics with and without robotics   
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Surgeons will review the below criteria and self-select whether they are eligible  
 Inclusion Criteria –  
Group A (35 surgeons) Board Certified surgeons   
Group B (18 surgeons) Board Certified surgeons with unrestricted robotic privileges  
 
 Exclusion Criteria – Surgeons unwilling to spend adequate time to participate in the 
study or those who are not Board Certified 
  
4.2 Secondary Subjects  
N/A 
 
4.3 Number of Subjects 
 
A. Total Number of Subjects   
53 
 
 
4.4 Consent Procedures 
 
A. Consent Process 
 
 Location of Consent Process   
In lieu of signing traditional informed consent, each surgeon will be provided with a 
Study Information Sheet.  Their participation in the study will serve as implied 
informed consent.  
 
 
 Consent Discussion Duration 
5 minutes or less 
 
 Coercion or Undue Influence  
 N/A 
 
 Subject Understanding  
Their participation will imply their understanding 
 
B. Waiver or Alteration of Consent Process  
 
 Waiver or Alteration Details   
This study does not involve any patient care or any other risky situations.  In fact, this 
study carries the smallest possible risks to the study subjects.  At the same time, the 
surgeons who agree to be subjects are very busy people.  Keeping the enrollment 
process to a minimum will be critical for obtaining participation.   
 

 
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Comparison of surgeons’ haptics with and without robotics   
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 Destruction of Identifiers   
No Identifiers will be collected  (see Figure 3)  
 
 Use of Deception/Concealment   
N/A 
a. Minimal Risk Justification   
No patient care of any kind will be included in the study.  The only study activity 
will be manipulation of inanimate objects.  
 
b. Alternatives   
Use of human or animal tissue is not practical, because the study design calls for 
uniformity of the model objects.  The materials within the balloons are similar to 
fluids that are present during surgical dissection.  
c. Subject Debriefing  
Each surgeon will be told whether or not they ordered the balloons correctly right 
after they do so, and they will be asked to keep this information to themselves.  
 
C. Documentation of Consent 
 Documenting Consent  
N/A 
 
 Waiver of Documentation of Consent (i.e., will not obtain subject’s signature)  
Each subject will receive a Study Information Sheet 
 
 
B. Removing a Subject   
If a subject decides to cease participation we will shred their forms and choose a 
subsequent study subject. 
 
 
4.6 Risks and Benefits to Subjects 
 
A. Description of Subject Risk And Benefits   
There are no risks to being in this study.   The benefits consist of the contribution each 
study subject will have made to further our knowledge of this topic.  
 
Existing Condition/Disorder   
N/A 
 
 
 Minimizing Risks  
N/A 
 Certificate of Confidentiality (CoC)  
N/A 

 
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Comparison of surgeons’ haptics with and without robotics   
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 Risks to Non-Subjects  
N/A 
 Potential Benefits  
The benefits consist of the contribution each study subject will have made to further 
our knowledge of this topic. 
 
 
5.0 Data Management Plan 
 
5.1 Data Analysis  
Continuous variables will be compared via T-tests or Mann-Whitney test as applicable; 
Categorical data will be compared via chi square test.   Power calculation / sample size estimate 
information as above.  
 
5.2 Data Security   
Dr. Culligan will keep the completed Case Report Forms in a folder in a secured briefcase until 
they can be entered into the electronic study database.  The case report forms will be preserved to 
allow for potential further analysis, but no personal identifiers will have been collected.  All 
study documents will be stored in the investigator’s locked and secured office at The Valley 
Hospital. 
 
5.3 Reporting Results 
 
A. Subject Results Reporting  
Our plan calls for data to be will be published in a peer reviewed journal.  We will share 
our information with all study subjects at their request. 
B. Professional Reporting  We plan to present our findings at a national meeting (such as 
SGS, AUGS or AAGL, and we intend to publish our findings in a peer-reviewed journal. 
 
5.4 Secondary Use of the Data 
 N/A   
 
 

 
Culligan 
Comparison of surgeons’ haptics with and without robotics   
v1 06.24.23 
Figure 1.  
Conventional laparoscopic surgery (which inherently includes haptic feedback to the 
surgeon) versus robotic-assisted surgery (which does not) 
 
 
 
 

 
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Comparison of surgeons’ haptics with and without robotics   
v1 06.24.23 
 
Figure 2.  
 
The balloons  - each filled with 20 mL of either air, water, petrouleum jelly or water 
absorbing crystals (consistency of a non-ripe banana) 
 
 

 
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Comparison of surgeons’ haptics with and without robotics   
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Figure 3.  
Case Report Form 1 
Surgeon Demographics 
 
Subject # __________________ 
 
Board Certification (circle all that apply)      FACS  
FACOG 
 
FPMRS 
 
  Other _______ 
 
Age ___________ 
 
Male Female 
non-Bianary 
 
Years since residency  _____________ 
 
Years since fellowship  _____________ 
 
Credentialed for robotic surgery      Y       N   
 
Approximate total number of robotic cases performed   ____________ 
 
 
 
 
 

 
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Figure 4. 
Case Report Form 2 
Study Data Collection 
Subject #  ________ 
Surgeon felt as though they could discern balloon contents using only sight?    Y     N 
 
Balloon discernment via manipulation 
 
HANDS 
 
ROBOT 
 
AIR 
 
 
WATER 
 
 
 
JELLY 
 
CRYSTALS 
Correct?   Y    N 
 
 
Y    N  
 
 
Y    N    
 
 
   
Y    N    
If No, which did they think it was? 
_____________ 
 
 
______________ 
 
___________ 
 
___________