The ERGOROB Project (ERGOnomics in Surgical ROBotics)
Phase: NA
Conditions: Ergonomics
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

 
 
 
 
 
 
 
Study code: ERGOROB 
 
 
 
Study title:  
The ERGOROB Project (ERGOnomics in surgical ROBotics) 
 
 
Author(s): 
Prof. Matteo Rottoli 
Dr Tommaso Violante 
Document 
Protocol 
Version: 
2.0  
Protocol date: 
28/01/2026 
Number of pages: 
26 
 
  

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Protocol (ERGOROB) 
 
version 2.0 of 28/01/2026 
PROTOCOL SIGNATURE PAGE   
 
 
Study code: ERGOROB 
 
 
      30/08/2025  
(Author 1) Matteo Rottoli 
signature 
 
date 
 
 
 
29/08/2025 
(Author 2) Tommaso Violante 
signature 
 
date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Protocol (ERGOROB) 
 
version 2.0 of 28/01/2026 
 
 
 
 
INVESTIGATOR'S STATEMENT: 
 
Study code: ERGOROB 
I declare that I have read the protocol and agree to conduct this clinical study in accordance with all the 
requirements of the protocol, the Good Clinical Practice guidelines and the Declaration of Helsinki 
principles. 
 
 
 
      30/08/2025 
(Principal Investigator) Matteo 
Rottoli 
signature 
 
date 
 
 
 
 
 
 
 
  
 
 
(Co-Principal Investigator) 
Tommaso Violante 
signature 
 
date 
 

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Protocol (ERGOROB) 
 
version 2.0 of 28/01/2026 
TABLE OF CONTENTS 
1 
LIST OF ABBREVIATIONS .................................................................................................................... 52
 
INTRODUCTION......................................................................................................................................... 62.1
 
BACKGROUND AND STUDY RATIONALE ..................................................................................................... 62.2
 
IMPORTANCE OF THE STUDY AND ITS CLINICAL RELEVANCE ...................................................................... 62.3
 
IS THE STUDY INCLUDED IN THE RESEARCH AREAS OF IRCCS AOU BOLOGNA? .......................................... 73
 
AIMS AND ENDPOINTS OF THE STUDY ...................................................................................................... 83.1
 
PRIMARY AIM(S) ........................................................................................................................................ 83.2
 
SECONDARY AIM(S) OPZIONALE ................................................................................................................. 83.3
 
ENDPOINTS ................................................................................................................................................... 84
 
STUDY PLAN ........................................................................................................................................... 104.1
 
TYPE OF STUDY ....................................................................................................................................... 104.2
 
MONO- OR MULTICENTRIC STUDY........................................................................................................ 104.2.1
 
Coordination among centers opzionale .............................. Errore. Il segnalibro non è definito.4.3
 
STUDY DESIGN ........................................................................................................................................ 104.4
 
STUDY POPULATION ............................................................................................................................ 114.4.1
 
Inclusion Criteria ................................................................................................................................ 114.4.2
 
Exclusion Criteria ............................................................................................................................... 124.4.3
 
Study population size and statistical power ........................................................................................... 124.5
 
INTERVENTION/TREATMENT UNDER INVESTIGATION .............................................................................. 124.6
 
POSSIBLE INTERVENTION/TREATMENT CONTROL/COMPARISON .............................................................. 144.7
 
STUDY DURATION ................................................................................................................................... 144.8
 
TREATMENTS, MONITORING AND EVALUATIONS .................................................................................. 154.8.1
 
First visit evaluations .......................................................................................................................... 164.8.2
 
Evaluations at follow-up visits and timing .......................................................................................... 164.8.3
 
Patient drop-out from the study opzionale ............................................................................................. 184.9
 
FUNDING.............................................................................................................................................. 184.9.1
 
Funding parties .................................................................................................................................... 184.10
 
DATA MANAGEMENT ........................................................................................................................... 184.11
 
STATISTICAL ANALYSIS PLAN (SAP) ................................................................................................ 194.11.1
 
Methodology of analysis ................................................................................................................... 194.11.2
 
Risk factors, confounders and effect modifiers ................................................................................. 194.11.3
 
Selection and matching criteria for controls opzionale .................................................................... 204.11.4
 
Policy for sharing data with other researchers/research groups (data sharing) ...................................... 205
 
ADMINISTRATIVE PROCEDURES AND STATEMENTS ............................................................................. 215.1
 
INFORMED CONSENT AND CONSENT TO THE PROCESSING OF PERSONAL DATA ..................................... 215.1.1
 
Modalities for acquiring informed consent and consent to the processing of personal data .............. 215.1.2
 
Study phase during which consents will be obtained .......................................................................... 215.1.3
 
Cases for which the acquisition of consent to the processing of personal data is not required............. 215.2
 
SPECIFIC STUDY INSURANCE ................................................................................................................... 215.3
 
AMENDMENTS TO THE PROTOCOL AND CHANGES IN THE CONDUCTION OF THE STUDY ........................... 215.4
 
STUDY CONCLUSION ........................................................... Errore. Il segnalibro non è definito.5.5
 
PUBLICATION OF RESULTS ................................................................................................................... 215.5.1
 
Strategies for the dissemination of results and for the reproducibility of research ............................ 225.5.2
 
Criteria for the order of authors in publications opzionale ................................................................... 225.6
 
STORAGE OF DOCUMENTATION .............................................................................................................. 225.7
 
INSPECTIONS/AUDITS ............................................................................................................................. 225.8
 
CONTACT PERSONS.................................................................................................................................... 226
 
BIBLIOGRAPHY ........................................................................................................................................... 23 

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Protocol (ERGOROB) 
 
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1 
 LIST OF ABBREVIATIONS 
 
 
ERGOROB 
ERGOnomics in surgical ROBotics 
RAS 
Robotic Assisted Surgery 
sEMG  
Surface Electromyography 
HRV 
Heart Rate Variability 
ECG 
Electrocardiogram 
ISO 
International Organization for Standardization 
GCP 
Good Clinical Practice 
CRF 
Case Report Form 
CND 
Classificazione Unica Nazionale (dei dispositivi medici) 
IVD 
In Vitro Diagnostic medical device 
IFU 
Instructions For Use 
PI 
Principal Investigator 
EC 
Ethics Committee 
SAP 
Statistical Analysis Plan 
DPIA 
Data Protection Impact  

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Protocol (ERGOROB) 
 
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2 
Introduction 
2.1 
Background and study rationale  
Surgery is a profession that demands both exceptional cognitive skills and remarkable physical 
resilience. Surgeons must possess intricate knowledge, honed through years of dedicated 
training, and the stamina to perform complex procedures that can extend for several hours. 
While a surgeon's expertise and judgment typically improve with experience, the cumulative 
physical burden of operating can have a significant impact on their health and well-being. 
Musculoskeletal disorders are a common concern, often arising from awkward postures, 
repetitive movements, and prolonged periods of standing. These disorders can potentially lead 
to premature career cessation, resulting in a loss of valuable surgical expertise. 
The evolution of surgical techniques has sought to minimize patient trauma and improve 
outcomes. Laparoscopy revolutionized surgery by replacing large incisions with small keyhole 
incisions. However, this technique introduced new ergonomic challenges for surgeons, who 
often find themselves in awkward positions with limited freedom of movement and reduced 
tactile feedback while manipulating long instruments through small incisions. These factors can 
contribute to muscle fatigue and strain. 
Robotic surgery represents the next step in minimally invasive surgery, offering the potential 
to overcome some of the limitations of laparoscopy. With robotic systems, surgeons control 
robotic arms from a console, providing enhanced dexterity, greater precision, and magnified 
3D visualization. This technology allows for a more ergonomic working posture, potentially 
reducing physical strain and improving surgeon comfort. Early research suggests that robotic 
surgery may indeed offer significant ergonomic advantages over traditional laparoscopy. 
Based on these considerations, this research project will pursue two distinct but related studies: 
The first study will examine the differential physical demands placed on colorectal surgeons 
when performing the same surgical procedure using both laparoscopic and robotic (Hugo RAS) 
approaches. 
The second study will evaluate the differential physical demands placed on surgeons when 
performing the same surgical procedure using the two most common robotic surgical platforms: 
the Hugo RAS (Medtronics) and the Da Vinci Xi system (Intuitive). 
These studies are classified as observational studies and are not considered post-market medical 
device investigations. None of the data collected will be used for regulatory purposes; all data 
will serve exclusively for a comparative evaluation of the ergonomics in different surgical 
approaches. 
2.2 
Importance of the study and its clinical relevance  
 This research aims to provide valuable insights into the ergonomic implications of different 
surgical approaches and contribute to the optimization of surgeon well-being and performance 
in the operating room. Understanding the physical demands can lead to improved surgical 
system design, better training protocols, and strategies to mitigate work-related musculoskeletal 
disorders among surgeons, ultimately preserving valuable surgical expertise and enhancing 
patient care. 

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WHAT IS ALREADY 
KNOWN ON THIS TOPIC 
 
● 
Musculoskeletal disorders are common among surgeons due to 
awkward postures and repetitive movements in traditional and 
laparoscopic surgery 
● 
Robotic surgery generally offers improved ergonomics over 
laparoscopy 
● 
Laparoscopy presents ergonomic challenges such as limited 
movement and reduced tactile feedback 
● 
Different robotic systems exist, but direct, comprehensive 
ergonomic comparisons are limited.
WHAT THE STUDY 
COULD ADD 
 
● 
Detailed, objective, comparative data on the specific physical 
demands and ergonomic differences between laparoscopic 
surgery and the Hugo RAS system for Low Anterior Resection 
of the Rectum 
● 
A direct comparison of the physical demands and ergonomic 
characteristics of two leading robotic platforms (Hugo RAS and 
Da Vinci Xi) during Radical Prostatectomy procedures, using a 
comprehensive suite of objective measures 
● 
Quantification of these challenges using advanced motion 
capture and physiological sensors during colorectal surgery, 
compared directly to a robotic alternative 
● 
Insights into the manipulation forces required by each robotic 
system (Hugo RAS vs. Da Vinci Xi) using specialized 
sensorized gloves
 
 
2.3 
Is the study included in the research areas of IRCCS AOU Bologna? 
Oncology  
 ☐ 
Transplants and severe organ deficiencies 
☐  
COVID-19 
☐  
Other research area 
 ☒ 
 

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3 
Aims and endpoints of the study 
3.1 
Primary aim(s) 
● Study 1: To conduct a comprehensive assessment of the physical demands and 
ergonomic implications of performing Low Anterior Resection of the Rectum using 
both laparoscopic and robotic (Hugo RAS) surgical approaches. The research 
hypothesis is that the robotic (Hugo RAS) approach will impose lower physical 
demands and offer superior ergonomic conditions for the operating surgeon compared 
to the standard laparoscopic approach for this procedure. 
● Study 2: To conduct a detailed comparison of the physical demands and ergonomic 
characteristics of two leading robotic surgical platforms – the Hugo RAS (Medtronics) 
and the Da Vinci Xi system (Intuitive) – in the context of Radical Prostatectomy 
procedures. The research hypothesis is that there will be measurable differences in 
physical demands and ergonomic characteristics between the Hugo RAS and Da Vinci 
Xi systems, which could have implications for surgeon comfort and strain during 
Radical Prostatectomy. 
 
3.2 
Secondary aim(s)  
● To identify specific surgical tasks or phases within Low Anterior Resection of the 
Rectum and Radical Prostatectomy that are associated with the highest physical and 
ergonomic loads for surgeons across the different platforms.  
● For Study 2, to compare the manipulation forces required by the Hugo RAS and Da 
Vinci Xi systems during Radical Prostatectomy. 
 
3.3 
Endpoints 
The aim of the study should not be repeated, but rather the specific measure that will be 
evaluated or calculated should be stated; on the basis of the results obtained for this 
measure it will be established if the results expected from the study have been achieved 
or not. 
 
Primary endpoint 
 
Primary endpoint 
How it will be measured  
 
 
When it will be evaluated  
● 
Posture (deviations) 
● 
Range 
of 
motion 
(upper limbs) 
● 
Repetitive 
movements 
(upper 
limbs) 
● 
Trunk 
flexion 
and 
lateral 
bending angles calculated from 
Xsens Motion Capture Suit data 
● 
Shoulder and elbow range of 
motion quantified from Xsens 
Motion Capture Suit data 
Throughout each surgical 
procedure for all primary 
endpoints (all the measurements 
will be acquired in real time) 
 

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● 
Muscle 
activity 
levels 
● 
Muscle fatigue 
● 
Muscle 
strain 
indicators 
● 
Physical exertion 
● 
Manipulation forces 
(Study 2 only) 
● 
Frequency and amplitude of 
repetitive movements analyzed 
from Xsens Motion Capture 
Suit data 
● 
Root mean square 
(RMS) 
values of sEMG signals from 
trapezius, erector spinae, biceps 
brachii, and forearm extensor 
muscles using WaveX sensors 
● 
Median frequency and spectral 
analysis of sEMG signals from 
WaveX sensors 
● 
Periods of sustained muscle 
activation and high levels of co-
contraction 
identified 
from 
sEMG signals using WaveX 
sensors 
● 
Peak forces, average forces, 
and force variability measured 
by sensorized gloves 
 
Secondary endpoints 
 
Secondary endpoints 
How it will be measured  
 
 
When it will be evaluated  
Identification 
of 
high-
demand 
surgical 
tasks/phases 
Correlation of specific tasks (identified 
from video recordings) with peaks in 
kinematic (Xsens) and physiological 
(sEMG,) data. 
Post-procedure 
analysis 
of 
synchronized data. 
Surgeon's 
interactions 
with 
surgical 
instruments/robotic 
console and workflow 
Qualitative and quantitative analysis of 
high-resolution video recordings. 
Post-procedure analysis of video data. 
Detailed measurements of 
robotic platforms (Study 2 
only) 
Physical measurements of surgeon's seat 
and interactive components of the robotic 
platforms. 
During data acquisition setup for Study 
2. 

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4 
Study plan 
4.1 
Type of study 
 
RCT 
 
 
 
 
☐ 
Non-randomized controlled study 
 
 
 
 
☐ 
Experimental study, uncontrolled 
 
 
 
 
☐ 
Cross-sectional study 
 
 
 
 
☐ 
Retrospective Case-control study 
  
 
 
 
☐ 
Retrospective cohort study 
 
 
 
 
☐ 
Prospective cohort study 
  
 
 
 
☒ 
Retrospective and prospective cohort study 
 
 
 
 
☐ 
 
4.2 
Mono- or multicentric study 
Monocentric  
☒  
National Multicentric 
☐  
International Multicentric 
☐ 
 
 
4.3 
Study design 
This research project comprises two related studies, both employing a within-subjects 
experimental design where each participating surgeon acts as their own control. 
● Study 1 (Comparative Analysis of Laparoscopic and Robotic Approaches in 
Colorectal Surgery): This study will compare the physical demands on surgeons 
performing Low Anterior Resection of the Rectum. Each of the 5 participating 
colorectal surgeons will perform the procedure 5 times using a standard laparoscopic 
approach and 5 times using the Hugo RAS robotic system. Data on posture, 
movement, muscle activity will be collected during each procedure. The order of 
procedures (laparoscopic vs. robotic) may be counterbalanced if feasible to minimize 
order effects. 
● Study 2 (Comparative Analysis of Two Robotic Platforms in Urological Surgery): 
This study will compare the physical demands on surgeons performing Radical 
Prostatectomy. Each of the 5 participating urological surgeons will perform the 
procedure 5 times using the Hugo RAS robotic system and 5 times using the Da Vinci 
Xi robotic system. Similar data as in Study 1 will be collected, with the addition of 
hand force measurements using sensorized gloves. The order of procedures (Hugo 
RAS vs. Da Vinci Xi) may be counterbalanced. 
 
For both studies, surgical procedures will be standardized to ensure comparability. Data 
collection will involve equipping surgeons with a suite of wireless sensors and recording the 
procedures with high-resolution video. An interim analysis will be conducted after 3 cases per 

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surgeon per approach in each study (30 total procedures per study) to assess data variability 
and re-evaluate the required number of procedures. 
4.4 
Study population 
The study population consists of experienced surgeons from two different specialties. 
● Study 1: 
o Participants: 5 experienced general surgeons with (aged 40-55 years) 
specializing in colorectal surgery. 
o Enrollment period: March - December 2026 (as per project timeline for patient 
recruitment and data acquisition). 
o UO/strutture di riferimento: Specific surgical units within IRCCS - Azienda 
Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi where 
eligible surgeons operate and where the specified procedures (Low Anterior 
Resection of the Rectum) are performed using both laparoscopic and Hugo 
RAS techniques. (Institution inferred based on template context). 
o Modalità di arruolamento: Eligible surgeons meeting inclusion criteria within 
the institution will be identified and invited to participate. 
● Study 2: 
o Participants: 5 experienced urological surgeons (aged 40-50 years) with 
expertise in robotic-assisted Radical Prostatectomy using both the Hugo RAS 
and Da Vinci Xi systems. 
o Enrollment period: March - December 2026 (as per project timeline for patient 
recruitment and data acquisition). 
o UO/strutture di riferimento: Specific surgical units within IRCCS - Azienda 
Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi where 
eligible surgeons operate and where Radical Prostatectomy is performed using 
both Hugo RAS and Da Vinci Xi systems. (Institution inferred based on 
template context). 
o Modalità di arruolamento: Eligible surgeons meeting inclusion criteria within 
the institution will be identified and invited to participate 
4.4.1 
Inclusion criteria  
 Study 1: 
● Experienced general surgeons specializing in colorectal surgery. 
● Age between 40-55 years. 
● Proficient in performing Low Anterior Resection of the Rectum using both standard 
laparoscopic techniques and the Hugo RAS robotic system (over 30 robotic and 
laparoscopic procedures completed). 
● Willingness to undergo extensive data collection during surgical procedures. 
● Provide written informed consent. 
Study 2: 
● Experienced urological surgeons. 
● Age between 40-50 years. 
● Expertise in robotic-assisted Radical Prostatectomy using both the Hugo RAS and Da 
Vinci Xi systems(over 20 radical prostatectomies performed on both platforms) 
● Willingness to undergo extensive data collection during surgical procedures. 

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● Provide written informed consent. 
4.4.2 
Exclusion criteria 
Not applicable 
4.4.3 
Study population size and statistical power 
Study 1: 
● Total number of participating surgeons: 5. Each surgeon will perform 10 procedures 
(5 laparoscopic, 5 Hugo RAS), for a total of 50 surgical procedures. 
● Considerations: The number of surgeons proficient in both laparoscopy and the 
relatively new Hugo RAS system for colorectal surgery is limited. 5 potential 
participants meeting inclusion criteria have been identified within the institution. The 
study involves a significant time commitment from surgeons. Statistical power is 
enhanced by a comprehensive data collection methodology and a within-subjects 
design, where each surgeon acts as their own control, increasing sensitivity to detect 
differences. The focus is on detecting clinically meaningful differences. An interim 
analysis will be conducted after 3 cases per surgeon per approach (30 total) to assess 
data variability and re-evaluate the required number of procedures; if needed, data 
from additional procedures will be collected. 
Study 2: 
● Total number of participating surgeons: 5. Each surgeon will perform 10 procedures 
(5 Hugo RAS, 5 Da Vinci Xi), for a total of 50 surgical procedures. 
● Considerations: The pool of urological surgeons experienced with both Hugo RAS 
and Da Vinci Xi systems is limited. 5 potential participants meeting inclusion criteria 
have been identified within the institution. The study involves a significant time 
commitment. Similar to Study 1, rigorous methodology, comprehensive data 
collection, and a within-subjects design are expected to provide meaningful results 
with this sample size. The focus is on clinically meaningful differences. An interim 
analysis will be conducted after 3 cases per surgeon per approach (30 total) to assess 
data variability and re-evaluate the required number of procedures; if needed, data 
from additional procedures will be collected. 
 
4.5 
Intervention/treatment under investigation  
This study investigates the ergonomic impact on surgeons using different surgical 
systems/approaches, which are considered the "interventions" from the perspective of surgeon 
ergonomics. 
Study 1 Intervention: Hugo RAS (Robotic Assisted Surgery) System 
● The Hugo RAS system (Medtronics) is a robotic surgical platform used for minimally 
invasive procedures. Surgeons operate from a console to control robotic arms that 
manipulate surgical instruments. 
▪ 
Hugo™ RAS system 
▪ 
Medtronic  

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▪ 
Medtronic  
▪ 
REF: 142239 
▪ 
SN: C22CAF0110 
o Risk class (IIb according to Directive (EU) 2017/745 (MDR)) 
o The console and robotic arms are multi-use; specific instruments and 
accessories may be single-use. 
o The full robotic system including surgeon console, vision cart, and robotic 
arms is required. 
o The Hugo RAS system is stated as being used for comparison, implying it is 
available/in use or will be made available. Compatibility with institutional 
infrastructure (power, space, network if applicable) is already available 
o For use in minimally invasive surgical procedures, including colorectal surgery 
(Low Anterior Resection of the Rectum for this study). 
o : As per manufacturer's Instructions For Use (IFU). Standard operating room 
environment. 
o Surgeons require specific training and experience on the Hugo RAS system. 
Participating surgeons are proficient. 
o The system is managed by surgical and hospital staff. 
o System is already in use 
Study 2 Interventions: Hugo RAS System and Da Vinci Xi System 
1. Hugo RAS System (Medtronics) * Details as described above for Study 1, with the 
intended use including urological procedures (Radical Prostatectomy for this study). 
Participating surgeons have expertise with this system for the specified procedure. 
2. Da Vinci Xi System (Intuitive) 
●  The Da Vinci Xi system (Intuitive) is a robotic surgical platform used for minimally 
invasive procedures. Similar to other robotic systems, surgeons operate from a console 
to control robotic arms. 
▪ 
da Vinci® Xi Surgical System 
▪ 
DAVINCI XI IS 4000 HD 
▪ 
Intuitive Surgical, Inc.  
▪ 
Intuitive Surgical, Inc. 
▪ 
REF: 129537 
▪ 
SN: 375738 
o Numero di repertorio: (To be specified) 
o Risk Class: (IIb according to Directive (EU) 2017/745 (MDR)) 
o The console and robotic arms are multi-use; specific instruments and 
accessories may be single use. 
o Yes, the full robotic system including surgeon console, vision cart, and robotic 
arms is required. 
o The Da Vinci Xi system is stated as being used for comparison, implying it is 
use. Compatibility si already confirmed. 
o use in minimally invasive surgical procedures, including urological surgery 
(Radical Prostatectomy for this study). 
o As per manufacturer's Instructions For Use (IFU). Standard operating room 
environment. 
o Yes, surgeons require specific training and experience on the Da Vinci Xi 
system. Participating surgeons have this expertise. 

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o Not applicable to the surgeon as the study subject. The system is managed by 
surgical and hospital staff. 
o is currently already in use at the institution 
Sensors used for ergonomic assessment (considered investigational tools for the purpose 
of this study on surgeons): 
● Xsens Motion Capture Suit (www.movella.com): Full-body suit with 17 inertial 
measurement units for 3D movement data. 
● WaveX Sensors (www.btsbioengineering.com): Wireless surface electromyography 
sensors. 
● GRIP VERSATEK(www.tekscan.com): Sensorized glove for measuring hand/finger 
force. 
For both studies the sensors have already been tested in a simulated environment to 
determine that none of the used equipment that will be employed in this study will affect 
the surgeon’s dexterity and comfort during the surgical procedures. 
 
It is currently already in use at IRCCS AOUBO 
  
☒ 
It will be provided on a free loan for use (multi-use DM) 
  
☐  
 
It will be provided free of charge by a third-party lender (single-use DM) 
☐ 
 
 
 
 
4.6 
Possible intervention/treatment control/comparison 
Study 1: The control/comparison is the standard Laparoscopic Surgical Approach for Low 
Anterior Resection of the Rectum. This involves surgeons manipulating long instruments 
through small incisions without robotic assistance, often leading to awkward postures and 
reduced tactile feedback. The specific laparoscopic instruments used will be those standardly 
employed by the participating surgeons for this procedure. 
 
Study 2: The two robotic platforms, Hugo RAS System and Da Vinci Xi System, are being 
directly compared against each other. Both are described in section 4.5. 
 
4.7 
Study duration 
● Total project duration: 2 years. 
● Estimated timeline for the phases:  
1. Acquisition of equipment, setting organization, pilot data acquisition: October 
2025 - March 2026 (approx. 7 months). 

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2. Enrollment/selection of surgeons and data acquisition (during patient 
procedures): March - December 2026 (approx. 10 months). (This involves 
observing surgeons during surgical procedures, so "treatment phase" applies to 
the actual patients undergoing surgery, while data is collected on surgeons.) 
3. Follow-up required for outcome assessment: Not applicable in the traditional 
sense for surgeons; data is collected per procedure. 
4. Data analysis and publication: January - May 2027 (approx. 5 months). 
The enrollment/selection of participants (surgeons) will begin subsequent to the study's 
approval by the Ethics Committee (expected September 2025) and the issuance of clearance by 
the General Director of the IRCCS. 
Estimated start and end dates of the study:  
● Presumed Start (Ethics approval): September 2025  
● Presumed Start (Equipment/Pilot): September 2025  
● Presumed Start (Surgeon Data Acquisition): March 2026  
● Presumed End (Publication): May 2027  
 
Phase of the study 
Time (months/years) 
Ethics committee submission & approval 
June 
2025 
- 
September 2025 (4 
months) 
Acquisition of equipment, organization, pilot data 
September 
2025 
- 
March 
2026 
(7 
months) 
Enrollment/selection of surgeons & data acquisition during 
procedures 
March 
2026 
- 
December 2026 (10 
months) 
Data analysis and publication 
January 2027 - May 
2027 (5 months) 
overall study duration 
2 years (approx.) 
 
4.8 
Treatments, monitoring and evaluations  
During each surgical procedure included in the study, participating surgeons will be equipped 
with an integrated system of wireless sensors for comprehensive ergonomic assessment. High-
resolution video recordings will also be made. 

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4.8.1 
First visit evaluations 
Clinical history/current therapy 
☐  
Previous therapies 
☐  
Overall assessment 
☐  
Laboratory tests 
☐  
Outpatient visits and/or specialized examinations 
☐  
Administration of questionnaires 
☐  
Administration of scales 
☐ 
Other 
☒  
(specify) 
 
 
(Evaluations are per-procedure, not per-visit in the traditional sense. The first procedure 
observed for each surgeon/approach combination will serve as their initial data point for that 
condition.) The following will be collected for each surgeon during each observed surgical 
procedure: 
● 
3D Movement Data: Using Xsens Motion Capture Suit (position, orientation, acceleration). 
● 
Muscle Activity (sEMG): Using WaveX sensors on trapezius, erector spinae, biceps brachii, 
and forearm extensor muscles. 
● 
Hand/Finger Forces (Study 2 only): Using grip versatek. 
● 
Video Recording: High-resolution video of the surgeon's movements, interactions, and 
workflow. 
 
4.8.2 
Evaluations at follow-up visits and timing 
 
Laboratory tests 
☐  
Outpatient visits and/or specialized examinations ☐  
Administration of questionnaires 
☐  
Administration of scales 
☐ 
Other………………………………………………….. 
☒  
(specify) 
 
Data collection as listed in 4.8.1 will occur during each of the 10 surgical procedures 
performed by each participating surgeon (5 procedures per approach/platform). These are 
not follow-up visits for the surgeons in a clinical sense, but rather repeated observation 
sessions during their standard surgical work under the specified conditions. The 
frequency of "visits" (i.e., observed surgical procedures) is 10 per surgeon, divided 

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between the two compared approaches/platforms. The evaluations are continuous 
throughout each surgical procedure. 
 
 
 
 
 
 
Type of 
evaluation 
Description 
Time of evaluation 
(days/months/years) 
Is it within 
normal clinical 
practice or is it 
study-specific? 
If already in 
clinical practice, 
is the timing 
different? 
Xsens 
Motion 
Capture  
Full-body 
3D 
movement 
data 
(posture, range of 
motion, repetitive 
movements). 
During each of the 
10 
surgical 
procedures 
per 
surgeon. 
Study-specific 
N/A 
WaveX sEMG  
Muscle 
activity, 
fatigue, and strain 
indicators 
from 
key 
muscle 
groups. 
During each of the 
10 
surgical 
procedures 
per 
surgeon. 
Study-specific 
N/A 
Grip 
Versatek 
(Study 2 only)  
Hand and finger 
forces 
during 
manipulation. 
During each of the 
10 
surgical 
procedures 
per 
surgeon (Study 2). 
Study-specific 
N/A 
High-
Resolution 
Video 
Recording  
Documentation of 
surgeon's 
movements, 
interactions, 
workflow. 
During each of the 
10 
surgical 
procedures 
per 
surgeon. 
Study-specific 
N/A 
Measurements 
of 
Robotic 
Platforms 
(Study 2)  
Detailed 
measurements of 
surgeon's seat and 
interactive 
components. 
Once per platform 
during setup. 
Study-specific 
N/A 

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4.8.3 
Patient drop-out from the study 
Surgeons may withdraw from the study at any time without prejudice. Conditions that might 
cause premature exit include: 
● Voluntary withdrawal by the surgeon. 
● Unforeseen changes in the surgeon's clinical duties or availability that prevent 
completion of the required number of procedures. 
● Technical difficulties with data acquisition equipment that cannot be resolved in a 
timely manner. If a surgeon drops out, efforts will be made to recruit a replacement if 
feasible and if the dropout occurs early in the data collection phase. Data collected 
from surgeons who do not complete the full set of procedures may be included in a 
modified analysis if appropriate or excluded from the primary per-protocol analysis. 
The interim analyses will help assess the impact of any dropouts on statistical power. 
Expected drop-out is minimal due to the small, selected cohort of highly motivated 
participants. A drop-out rate exceeding 20% (i.e., more than 1 surgeon per study) 
would trigger a re-evaluation of recruitment feasibility and sample size. 
 
4.9 
Funding 
Is funding provided for the study? 
No  
☐  
Yes, from internal funds 
☐  
Yes, from institutional third parties 
☐  
Yes, from private third parties 
☒  
 
 
4.9.1 
Funding parties  
 Medtronic (for the overall project or a significant part, including General Surgery and 
Urology budget allocation)  
● Goal of the funding: To support research into the ergonomic aspects of surgical 
robotics, specifically involving the Hugo RAS system. 
 
4.10 
Data Management 
The clinical data required by the protocol will be collected in pseudonymized form by personnel 
designated by the Principal Investigator in an electronic Data Collection Form (CRF) and will be 
managed through the REDCap platform. The eCRF in REDCap will be requested and implemented 
according to the procedure described in the "Corporate Operational Instruction for the Management and 
Use of the REDCap Platform" (IOA119). The Principal Investigator must indicate the names of 
personnel delegated to data management by specifying their relative functions within the study in the 
Delegation log. 
Data from sensors (Xsens, FREEEMG, Sensorized Gloves) will be processed using dedicated software 
for each system and then exported for integrated analysis. Video recordings will be stored securely. 

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4.11 
Statistical Analysis Plan (SAP) 
4.11.1 Methodology of analysis 
A comparative analysis of the sensor data and video recordings will be performed to evaluate 
key ergonomic parameters for each study. 
● Study 1: Comparison between laparoscopic approach and Hugo RAS system for Low 
Anterior Resection of the Rectum. 
● Study 2: Comparison between Hugo RAS system and Da Vinci Xi system for Radical 
Prostatectomy. 
The analysis will involve: 
● Kinematic data (Xsens): Statistical comparison (e.g., paired t-tests or non-parametric 
equivalents, ANOVA/ANCOVA for repeated measures) of posture angles (trunk 
flexion, lateral bending), range of motion (shoulder, elbow), and frequency/amplitude 
of repetitive movements between the compared conditions. 
● sEMG data (WaveX): Comparison of RMS values (muscle activation), median 
frequency changes (fatigue), and duration of sustained activation/co-contraction 
(strain) across different surgical phases and overall procedure between conditions. 
● Force data (Grip Versatek Gloves - Study 2 only): Comparison of peak forces, 
average forces, and force variability between the Hugo RAS and Da Vinci Xi systems. 
● Video data: Qualitative analysis of workflow, surgeon movements, and interactions. 
Quantitative analysis where applicable (e.g., task duration, frequency of specific 
movements or instrument exchanges). 
● Synchronized analysis of sensor and video data will be performed to link objective 
ergonomic measures to specific surgical tasks and phases. 
● For Study 2, the analysis will reference recognized scientific and technical standards, 
such as ISO 6385 (Ergonomic principles in the design of work systems), to provide an 
objective assessment. 
● An interim analysis will be conducted after 3 cases per surgeon per approach (30 total 
per study) to assess variability and inform if additional procedures are needed. 
● Methods to manage missing data will be considered (e.g., imputation if appropriate 
and limited, or complete case analysis). Sensitivity analyses may be conducted to 
assess the robustness of findings to different assumptions or analytical choices. 
4.11.2 Risk factors, confounders and effect modifiers 
  Potential Confounders/Effect Modifiers:  
● Surgeon experience (though controlled by inclusion criteria requiring proficiency and 
within-subjects design ). 
● Case complexity (procedures will be standardized as much as possible ). 
● Duration of surgery. 
● Order of surgical approach/platform (will be counterbalanced if feasible). 
● Individual surgeon anthropometry and baseline physical condition. 
  Data Sources: Surgeon demographic data (age, years of experience – collected at 
baseline), procedure logs (duration, specific events), sensor data itself.  

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  The within-subjects design, where each surgeon acts as their own control, is the primary 
method to control for inter-individual variability. 
4.11.3 Selection and matching criteria for controls  
Not applicable, as this is not a case-control study. Each surgeon serves as their own control. 
4.11.4 Policy for sharing data with other researchers/research groups (data sharing)  
Upon completion of the study and publication of primary results, anonymized datasets 
(primarily processed ergonomic and physiological parameters, not raw sensor feeds or 
identifiable video) may be made available to other researchers upon reasonable request to the 
Principal Investigator and subject to a data sharing agreement.  
 

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5 
Administrative procedures and statements  
5.1 
Informed consent and consent to the processing of personal data 
The study protocol, any amendments to the protocol, informed consent, consent to the processing of 
personal data and any other information for patients must be approved by the Ethics Committee.  
To be included in the study, each surgeon must provide written informed consent as well as consent to 
the processing of his or her personal data. 
5.1.1 
Modalities for acquiring informed consent and consent to the processing of personal 
data 
The Principal Investigator or a delegated co-investigator (e.g., experienced research staff 
familiar with the protocol and ethical considerations) will be responsible for acquiring informed 
consent from the participating surgeons. This process will take place within the IRCCS AOU 
Bologna, likely in a private office or meeting room within the relevant surgical departments, 
prior to any study-specific procedures or data collection. Surgeons will be given adequate time 
to read the information sheet, ask questions, and consider participation. 
5.1.2 
Study phase during which consents will be obtained 
Screening 
☒  
Baseline 
☐  
First follow-up visit 
 ☐ 
 
 
5.1.3 
Cases for which the acquisition of consent to the processing of personal data is not 
required 
Not applicable for this study, as all participants (surgeons) will be prospectively enrolled and 
will provide consent for the collection and processing of their ergonomic and physiological 
data. This study does not involve retrospective data collection from individuals unable to 
consent 
5.2 
Specific study Insurance 
Due to the observational nature of the study, no study-specific insurance is stipulated. 
 
5.3 
Amendments to the protocol and changes in the conduction of the study 
Any changes to the protocol will be made through an amendment, which will be submitted to the 
Ethics Committee. No other mode of amendment to the protocol is allowed during the study period. 
Any unexpected changes in the conduct of the study will be recorded in the "Clinical Study Report." 
5.4 
Publication of results 
The investigator commits to:  
● notify the conclusion of the study  
● submit the study for publication to a peer-reviewed journal within 12 months of study 
completion and regardless of the nature of its results  

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● use the correct affiliation of our research institution (IRCCS Azienda Ospedaliero-Universitaria 
di Bologna) in the scientific publications that will be submitted, 
For this purpose, the study will be registered on an Open Science platform (for example: osf.io, 
clinicaltrials.gov). Any formal submission or publication of data derived from this study shall be 
considered as a publication on behalf of the Investigator. 
 
5.4.1 
Strategies for the dissemination of results and for the reproducibility of 
research 
Strategies for the dissemination of results include: 
● Publication in high-impact, peer-reviewed scientific journals relevant to surgery, 
ergonomics, and medical technology. 
● Presentations at national and international scientific conferences and congresses. 
● Internal dissemination within IRCCS AOU Bologna to relevant departments and 
stakeholders. 
● Potentially, results could inform training programs for surgeons or guidelines for 
ergonomic best practices in surgery. Reproducibility will be supported by detailed 
methodology in publications, adherence to reporting guidelines, and the data sharing 
policy outlined in section 4.11.4. 
 
5.4.2 
Criteria for the order of authors in publications  
Authorship will be determined based on the International Committee of Medical Journal Editors 
(ICMJE) criteria. The order of authors will be decided by mutual agreement among the research 
team, reflecting the relative contributions to study design, data acquisition, analysis, 
interpretation, and manuscript preparation. The Principal Investigator will typically be the 
senior author. 
5.5 
Storage of Documentation 
The Investigator is responsible for the storage and preservation of the essential documents of the 
study, before, during the course of, and after the completion or interruption of the study, in accordance 
with the requirements of current regulations and GCP and corresponding timelines.  
The data collected in the CRF will be in strictly pseudonymous form and the subject will only be 
identified with a number/code. 
The Investigator shall keep the original patient data and the signed informed consent in a safe place to 
ensure that confidentiality and privacy are maintained.  
5.6 
Inspections/Audits 
If a Regulatory Authority requests an inspection, the Investigator is required to inform the Ethics 
Committee immediately.  
5.7 
Contact Persons 
The telephone numbers and e-mail addresses of the contact persons for the conduction of the study are 
listed in the Investigator Folder at the center. 
 

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6 
Bibliography 
1- Epstein S, Sparer EH, Tran BN, et al. Prevalence of Work-Related Musculoskeletal Disorders 
Among Surgeons and Interventionalists: A Systematic Review and Meta-analysis. JAMA 
Surg. 2018;153(2):e174947.  
2- Rao P, Jones CB, Rhea S, et al. Ergonomics and the risk of musculoskeletal disorders in 
surgeons. J Am Coll Surg. 2016;222(4):734-744.  
3- Schink M, Pfirrmann CW, Li X, et al. Occupational risk factors for spine pain among 
surgeons: a systematic review. Spine J. 2014;14(1):161-173.  
4- Wauben LS, van den Dobbelsteen JJ, Goossens RH, et al. Ergonomic evaluation of 
laparoscopic surgery. Surg Endosc. 1999;13(4):333-337.  
5- Berguer R. Surgical technology and the ergonomics of laparoscopic instruments. Surg Endosc. 
2002;16(7):1058-1062.  
6- Carragee EJ, Alamin TF. The burden of musculoskeletal disorders in surgeons. J Bone Joint 
Surg Am. 2013;95(11):e77.  
7- Hogle NJ, Fowler DL, Cooper JB. Human factors and error prevention in laparoscopy. J Am 
Coll Surg. 2008;207(1):125-135.  
8- Smidt AS, Berguer R. Ergonomics of robotic surgery. Surg Clin North Am. 2012;92(6):1429-
1440.  
9- Gorce P, Jacquier-Bret J. Effect of Assisted Surgery on Work-Related Musculoskeletal 
Disorder Prevalence by Body Area among Surgeons: Systematic Review and Meta-Analysis. 
Int J Environ Res Public Health. 2023 Jun 27;20(13):6419.  
10- Payne SC, Dauterive FR, Senagore AJ. Robotic surgery improves surgeon ergonomics. Surg 
Endosc. 2009;23(7):1581-1585.  
11- Berguer R. Minimally invasive surgery: the next revolution. Surg Innov. 2014;21(1):1-3.