The Hugo RAS Colorectal Collaborative (HRCC): An International Study to Advance Minimally Invasive Surgery
Conditions: Colorectal Surgery, Robotic Surgery, ColoRectal Cancer and Inflammatory Bowel Disease
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

 
 
 
 
 
 
Study code: HRCC 
 
 
 
 
Study title: The Hugo RAS Colorectal Collaborative 
(HRCC): An International Study to Advance Minimally 
Invasive Surgery 
 
 
Author(s): 
Prof Matteo Rottoli 
Dr Tommaso Violante 
 
 
Document 
Protocol 
Version: 
1  
Protocol date: 
 30/08/2025 
Number of pages: 
22 
 
  

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Protocol HRCC 
 
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PROTOCOL SIGNATURE PAGE   
 
 
Study code: HRCC 
 
 
 
 
 
 
      30/08/2025  
 
(Author 1) Matteo Rottoli 
signature 
 
date 
 
 
 
 
 
 
  
      30/08/2025 
 
(Author 2) Tommaso Violante 
signature 
 
date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Protocol HRCC 
 
version 1 of 30/08/2025 
 
 
 
 
INVESTIGATOR'S STATEMENT: 
 
Study code: HRCC 
 
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 
 
 
 
 
 
  
      30/08/2025 
(Co- Principal Investigator) 
Tommaso Violante 
signature 
 
date 
 

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Protocol HRCC 
 
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TABLE OF CONTENTS 
 
1 
LIST OF ABBREVIATIONS 
652
 
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) 
83.3
 
ENDPOINTS 
84
 
STUDY PLAN 
104.1
 
TYPE OF STUDY 
104.2
 
MONO- OR MULTICENTRIC STUDY 
104.2.1
 
Coordination among centers 
104.3
 
STUDY DESIGN 
104.4
 
STUDY POPULATION 
114.4.1
 
Inclusion Criteria 
114.4.2
 
Exclusion Criteria 
114.4.3
 
Study population size and statistical power 
114.5
 
INTERVENTION/TREATMENT UNDER INVESTIGATION 
124.6
 
POSSIBLE INTERVENTION/TREATMENT CONTROL/COMPARISON 
134.7
 
STUDY DURATION 
134.8
 
TREATMENTS, MONITORING AND EVALUATIONS 
144.8.1
 
First visit evaluations 
144.8.2
 
Evaluations at follow-up visits and timing 
144.8.3
 
Patient drop-out from the study 
164.9
 
FUNDING 
164.9.1
 
Funding parties 
164.10
 
DATA MANAGEMENT 
164.11
 
STATISTICAL ANALYSIS PLAN (SAP) 
164.11.1
 
Methodology of analysis 
164.11.2
 
Risk factors, confounders and effect modifiers 
174.11.3
 
Selection and matching criteria for controls 
Errore. Il segnalibro non è 
definito.4.11.4 
Policy for sharing data with other researchers/research groups (data sharing)
 
19 
5 
ADMINISTRATIVE PROCEDURES AND STATEMENTS 
20195.1
 
INFORMED CONSENT AND CONSENT TO THE PROCESSING OF PERSONAL DATA 
195.1.1
 
Modalities for acquiring informed consent and consent to the processing of personal data 
195.1.2
 
Study phase during which consents will be obtained 
195.1.3
 
Cases for which the acquisition of consent to the processing of personal data is not required 
195.2
 
SPECIFIC STUDY INSURANCE 
205.3
 
AMENDMENTS TO THE PROTOCOL AND CHANGES IN THE CONDUCTION OF THE STUDY 
205.4
 
STUDY CONCLUSION 
Errore. Il segnalibro non è definito.5.5
 
PUBLICATION OF RESULTS 
21 
5.5.1 Strategies for the dissemination of results and for the reproducibility of research 
21205.5.2
 
Criteria for the order of authors in publications 
Errore. Il segnalibro non è definito.5.6
 
STORAGE OF DOCUMENTATION 
22 

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5.7 
INSPECTIONS/AUDITS 
215.8
 
CONTACT PERSONS 
216
 
BIBLIOGRAPHY 
22 

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1 
 LIST OF ABBREVIATIONS 
 
 
 
CRF 
Case Report Form 
GCP 
Good Clinical Practice 
BMI 
 Body Mass Index 
HRCC 
 Hugo RAS Colorectal Collaborative 
IBD 
 Inflammatory Bowel Disease 
RAS 
 Robotic-Assisted Surgery (implied from Hugo RAS System) 
 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
 

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2 
Introduction 
2.1 
Background and study rationale  
. Minimally invasive surgery is rapidly becoming the standard of care in colorectal surgery, with 
procedures like laparoscopy offering significant benefits to patients compared to open surgery(1). 
However, traditional laparoscopy has limitations, including reduced dexterity, challenging ergonomics 
for surgeons, and limitations in visualization (2). The Hugo Robotic-Assisted Surgery (RAS) system 
represents a significant advancement in robotic surgery, designed to overcome these challenges and 
further improve patient outcomes (3). 
The Hugo RAS system offers several key features (4): 
● 
Wristed Instruments: Enabling greater dexterity and range of motion, particularly crucial in 
complex colorectal procedures. 
● 
Improved Ergonomics: Reducing surgeon fatigue and potentially enhancing precision, 
especially during prolonged operations. 
● 
Enhanced 3D Visualization: Providing a more immersive and detailed view of the surgical field 
for improved decision-making. 
● 
Modular Architecture: Allowing flexible configuration and customization to meet the specific 
needs of different surgical procedures and hospital environments, enhancing versatility and 
cost-effectiveness. 
Early studies confirm the safety and effectiveness of the Hugo RAS system in colorectal surgery. 
However, long-term studies including oncologic outcomes analysis are still lacking (5). An international 
multicentre study, the Hugo RAS Colorectal Collaborative (HRCC), is proposed to provide necessary 
real-world evidence to address these knowledge gaps. This study will investigate patients undergoing 
colorectal surgery using the Hugo RAS system.  
2.2 
Importance of the study and its clinical relevance  
The proposed "Hugo RAS Colorectal Collaborative" (HRCC) aims to analyse the short and 
long term outcomes of colorectal surgery performed by the use of Hugo RAS platform. The 
results of this study will contribute to highlight the effectiveness of robotic surgery in the 
treatment of various colorectal conditions, also using new platforms with a unique design 
such as the modular system of Hugo RAS. Furthermore, the study will contribute to the body 
of knowledge on robotic colorectal surgery and drive innovation in minimally invasive 
techniques. The registry will also provide data to support. 
WHAT IS ALREADY 
KNOWN ON THIS 
TOPIC 
 
Minimally invasive surgery is beneficial in colorectal surgery, but 
traditional laparoscopy has limitations 
 
The Hugo RAS system offers technological advancements like 
wristed instruments, improved ergonomics, and 3D visualization. 
 
Early studies on Hugo RAS clinical outcomes are limited, hindering 
widespread adoption 
WHAT THE STUDY 
COULD ADD 
 
Comprehensive real-world evidence on the short and long-term 
outcomes of the Hugo RAS system across a diverse range of 
colorectal procedures and patient populations. 
 
Data to inform best practices for robotic platform use, optimize 
patient care, and drive innovation in robotic colorectal surgery. 
 

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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) 
The primary aim of this study is to analyse the short and long-term  outcomes of patients undergoing 
colorectal surgery using the Hugo RAS system, by the mean of establishing an international dataset, the 
Hugo RAS Colorectal Collaborative (HRCC) 
Secondary aim(s) 
Secondary aims include: 
● To compare specific clinical outcomes (e.g., recovery times, post-operative 
complications) among participating centers to identify surgical best practices. 
● To foster the standardization of surgical techniques and setup procedures for 
colorectal surgery with the Hugo RAS system among participating centers. 
● To evaluate the learning curve of surgeons using the system for this type of procedure. 
 
3.2 
Endpoints 
Primary endpoint 
 
Primary endpoint 
How it will be measured  
 
 
When it will be evaluated  
● Short 
term 
outcomes of the 
Hugo 
RAS 
system 
● Intraoperative 
complications 
(e.g., 
robotic 
arm 
conflicts, 
system alarms including 
red 
alarms, 
technical 
difficulties encountered); 
Postoperative 
complications 
(using 
Clavien-Dindo 
classification). 
● Intraoperatively; 
Postoperatively (e.g., 
30-day, 90-day) 
● Efficacy of the 
Hugo 
RAS 
system 
● Operative 
time, 
blood 
loss; Conversion rates to 
open 
or 
laparoscopic 
surgery; 
Length 
of 
hospital stay, readmission 
rates; 
Pathological 
outcomes (e.g., margin 
status, lymph node yield).
● Intraoperatively; 
Postoperatively; Upon 
pathology report 

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● Long-term 
outcomes 
after 
Hugo 
RAS 
assisted 
colorectal surgery 
● Disease recurrence rates, 
survival data (overall and 
disease-free); Long-term 
functional outcomes (e.g., 
bowel function); Patient-
reported quality of life. 
● Long-term follow-up 
(e.g., 1 year, 3 years, 
post-surgery 
Secondary endpoints 
 
Secondary 
endpoints 
How it will be measured  
When it will be evaluated  
Hugo RAS system 
utilization patterns 
Data on system configuration 
(number 
of 
arms, 
specific 
instruments used), docking time, 
setup 
time, 
module 
usage; 
Frequency and reasons for alarms, 
technical difficulties. 
Intraoperatively, collected for 
each procedure. 
Data 
of 
robotic 
approach and docking 
of the robot 
Analysis of system performance 
data, 
utilization 
of 
different 
settings, 
and 
user 
feedback 
(qualitative, if collected during 
collaborative meetings ). 
Periodically 
throughout 
the 
study, during data analysis 
phases. 
Cost-effectiveness of 
Hugo RAS assisted 
colorectal surgery 
Analysis 
of procedural costs, 
length 
of 
stay, 
complication-
related costs, compared to potential 
benefits (specific metrics to be 
defined 
in 
cost-effectiveness 
analysis plan). 
After sufficient data collection, 
planned for Year 3 analysis. 
Standardization 
of 
techniques 
and 
collaborative learning 
Documentation of shared practices; 
Feedback 
from 
participating 
centers; Adoption rates of any 
consensus guidelines developed 
through the collaborative. 
Through 
periodic 
online 
meetings and updates; Ongoing 
throughout the registry. 

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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 
Clinical investigation with a CE-marked device used within its intended use, not 
conducted for conformity assessment purposes (Art. 82 of Regulation (EU) 2017/745).
 
 
 
 
 
☒☐ 
4.2 
Mono- or multicentric study 
Monocentric  
☐  
National Multicentric 
☐  
International Multicentric 
☒ 
 
 
4.2.1 Coordination among centers 
Coordination among participating centers will be managed by the principal investigator's 
institution. Key coordination activities will include: 
● Providing standardized electronic data collection forms (eCRFs) developed in 
REDCap to all centers. 
● Providing data dictionaries to all participating centers to ensure data standardization. 
● Conducting regular audits to maintain data quality. 
● Organizing periodic online meetings and updates to share analysis updates and key 
findings with participating centers. These meetings will also facilitate discussion and 
standardization of surgical techniques and setup procedures, and foster collaboration 
and knowledge exchange among surgeons and researchers. 
4.3 
Study design 
This study is a prospective, observational, international, multicenter dataset of patients 
undergoing colorectal surgery using the Hugo RAS system. The aim is to collect 
comprehensive real-world data on the system's utilization and patient outcomes across a 

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diverse range of procedures and patient populations. Data will be collected via standardized 
electronic Case Report Forms (eCRFs). This is an observational study where patients will 
receive treatment (surgery with the Hugo RAS system) according to the standard clinical 
practice of the participating centers. Measures to reduce bias include: 
● Standardized data collection using eCRFs in REDCap. 
● Provision of data dictionaries to ensure data standardization across centers. 
● Implementation of data quality control measures, including range checks, data 
validation rules, and regular data audits. 
● Enrollment of all eligible patients undergoing Hugo RAS colorectal surgery at 
participating centers to minimize selection bias. 
 
4.4 
Study population 
Participants will be adult patients (≥18 years) undergoing any type of colorectal surgery (elective 
or emergent) using the Hugo RAS system at participating high-volume colorectal surgery centers 
across multiple countries. The enrollment period will begin in Year 1 of the study, continue 
through Year 2, and potentially expand in Year 3, with ongoing long-term follow-up. Specific start 
and end dates for overall enrollment are yet to be defined and will depend on funding acquisition 
and ethical approvals. The coordinating center will be Alma Mater Studiorum - IRCCS 
Sant’Orsola-Malpighi Hospital, Bologna, Italy (Affiliation: IRCCS - Azienda Ospedaliero-
Universitaria di Bologna Policlinico S. Orsola-Malpighi). Other participating UO/structures will be 
high-volume colorectal surgery centers recruited internationally. Participants will be identified 
and enrolled at the participating centers when they are scheduled for colorectal surgery to be 
performed with the Hugo RAS system. 
4.4.1 Inclusion criteria  
 Adult patients (age ≥18 years). 
 Scheduled to undergo any type of colorectal surgery (elective or emergent) where the Hugo 
RAS system is planned to be used. 
 Willing and able to provide written informed consent. 
4.4.2 Exclusion criteria 
 Patients unable to provide informed consent.  
4.4.3 Study population size and statistical power 
This study is designed as a clinical investigation aimed at collecting real-world data. Based on the case 
volume of the participating centers and the study duration, the target sample size is set at 2000 patients. 
This sample size is considered sufficient to provide descriptive data on safety and performance 
endpointsThe total number of patients to be enrolled in the registry is not fixed with a formal sample 
size calculation, as this is a prospective observational registry aiming to collect comprehensive data 
from a diverse network of high-volume colorectal surgery centers (defined as performing at least 100 
colorectal procedures per year). Enrollment will depend on the number of participating centers and their 
caseloads over the study period. The aim is to gather a substantial dataset to allow for meaningful 
analysis of efficacy, short and long-term outcomes. The number of patients to be recruited at the IRCCS 
Azienda Ospedaliero-Universitaria di Bologna will be detailed in the center-specific moduleof 400 
patients. 

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4.5 
Intervention/treatment under investigation  
The technology under investigation is the Hugo™ RAS (Robotic-Assisted Surgery) System, 
manufactured by Medtronic, used for performing colorectal surgical procedures. This is a 
medical device. The purpose of this study is to analyze the short- and long-term clinical 
outcomes in patients undergoing oncologic colorectal surgery performed with the Hugo™ 
RAS robotic surgery system. 
The following information pertains to the Hugo RAS System: 
● ™ RAS System. Manufacturer: Medtronic. (REF and specific supplier details to be 
added if required). 
● Risk Class: To be added based on device documentation, typically Class IIb or III for 
robotic surgical systems). 
● The Hugo RAS System console and arms are multi-use. Surgical instruments used 
with the system may be single-use or multi-use. Details of specific instruments used 
will be recorded. 
● The Hugo RAS System is the primary apparatus. It consists of a surgeon console, 
robotic arms with instrument manipulators, and a vision cart. 
● For any participating center where the Hugo RAS system is newly installed for the 
purpose of this registry or otherwise, compatibility verification by the respective 
hospital's Clinical Engineering service (or equivalent) will be ensured as per local 
institutional policy. 
● The Hugo RAS System is intended for performing minimally invasive colorectal 
surgical procedures. 
● The Hugo RAS System will be stored, prepared, and used according to the 
manufacturer's (Medtronic) instructions for use (IFU) and guidelines by trained 
surgical teams. Data on technical setup including docking time, system configuration, 
setup time, and module usage will be collected. 
● Use of the Hugo RAS system requires specific training provided by the manufacturer 
(Medtronic) or certified trainers. Surgeons participating in the registry will be 
expected to have completed the required training and possess experience in minimally 
invasive colorectal surgery. The coordinating center (IRCCS - Azienda Ospedaliero-
Universitaria di Bologna Policlinico S. Orsola-Malpighi) possesses experience with 
robotic surgery. The collaborative nature of the registry aims to facilitate discussion 
and standardization of surgical techniques and setup procedures. 
● Not applicable, as the Hugo RAS system is a surgical tool operated by the surgical 
team and does not have direct patient management features or remote control by the 
patient. 
o It is currently already in use at IRCCS AOUBO  
o For other participating centers, the system may be already in use or will be 
acquired/provided according to their agreements. This registry does not 
directly fund the purchase of systems but collaborates with centers using Hugo 
RAS. 
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) ☐ 
 
 

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4.6 
Possible intervention/treatment control/comparison 
This is an observational registry focused on the Hugo RAS system. There is no active control 
group assigned by the protocol. However, the statistical analysis plan includes "Comparative 
effectiveness analyses". These analyses may involve internal comparisons between different 
techniques or patient subgroups within the Hugo RAS cohort, or potentially comparisons with 
historical data or published literature on other surgical modalities (e.g., traditional 
laparoscopy, open surgery) for context, though these are not prospectively controlled 
comparisons. 
4.7 
Study duration 
The total expected duration for the initial phase of the study (including primary data collection, 
analysis, and initial publications) is approximately 2 years, with long-term follow-up and data 
analysis continuing thereafter. 
Phase of the study 
Time (months/years) 
enrollment/selection of patients  
Year 
1 
(initiation), 
Year 2 (continuation), 
Year 3 (expansion). 
Estimated 
24-36 
months for primary 
enrollment. 
treatment phase (if any) 
Duration of surgery 
and hospitalization for 
each patient. 
follow-up required for outcome assessment  
Long-term follow-up 
data will be collected 
(e.g., up to 3 years or 
more post-surgery for 
outcomes 
like 
recurrence 
and 
survival) 
data analysis 
Initial analysis in Year 
2; 
Further 
analyses 
(cost-effectiveness, 
long-term outcomes) in 
Year 3 and ongoing. 
overall study duration 
Approximately 
3 
years, 
followed 
by 
extended 
long-term 
follow-up and analysis.
 

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4.8 
Treatments, monitoring and evaluations  
Data will be collected across the preoperative, intraoperative, postoperative, and long-term 
follow-up phases. Standardized electronic data collection forms (eCRFs) will be used. 
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) 
 
  
 
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) 
 
 
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? 
Intraoperative 
Data 
Collection 
Technical setup, 
surgical 
procedure 
details, system 
performance 
(arm conflicts, 
alarms). 
Intraoperatively 
Study-specific 
detailed data 
capture of 
routine 
procedure 
elements. 
No 

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Postoperative 
Complications 
Assessed using 
Clavien-Dindo 
classification. 
During 
hospital 
stay and up to 
30/90 days post-
discharge. 
Normal clinical 
practice 
(assessment); 
study-specific 
(standardized 
recording using 
Clavien-Dindo). 
No 
Length 
of 
Hospital Stay, 
Readmission 
Rates 
Data 
on 
discharge 
date 
and 
any 
readmissions. 
At discharge; up to 
30/90 
days 
for 
early readmissions. 
Normal clinical 
practice (data 
points); study-
specific 
(systematic 
collection for 
registry). 
No 
Pathology 
Reports 
Histopathology 
reports 
(tumor 
characteristics, 
margins, lymph 
node status). 
When 
available 
post-surgery. 
Normal clinical 
practice; study-
specific 
(systematic 
collection of 
predefined data 
points). 
No 
Adjuvant 
Therapy 
Details 
of 
chemotherapy, 
radiation 
therapy. 
As 
applicable 
following surgery. 
Normal clinical 
practice; study-
specific 
(systematic 
collection for 
registry). 
No 
Long-Term 
Follow-Up 
(Recurrence, 
Survival) 
Monitoring for 
disease 
recurrence, 
collection 
of 
survival data. 
Annually or as per 
standard 
oncological 
follow-up 
(e.g., 
6m, 
1yr, 
then 
yearly up to 3yrs+).
Normal clinical 
practice (follow-
up visits); 
study-specific 
(systematic data 
extraction for 
these 
endpoints). 
No 

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Functional 
Outcomes 
& 
Quality of Life 
Questionnaire
s 
Standardized 
questionnaires 
for 
bowel 
function, overall 
QoL. (given by 
the personnel of 
the 
surgical 
department) 
Baseline, and e.g., 
6 months, 1 year, 2 
years, 3 years post-
surgery. 
May be study-
specific if not 
part of routine 
follow-up at all 
centers, or if 
specific 
instruments are 
mandated. 
Potentially, 
if 
frequency 
or 
instruments 
differ. 
4.8.3 Patient drop-out  from the study 
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  
Covidien AG (Medtronic) will be supporting this study but will not be involved in any part of 
it. The purpose of the funding is to support the establishment and operation of the Hugo RAS 
Colorectal Collaborative (HRCC) international registry. 
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. 
 
4.11 Statistical Analysis Plan (SAP) 
4.11.1 Methodology of analysis 
The statistical analysis will use appropriate methods to address the study aims, including 
descriptive and inferential statistics. Comparative effectiveness analyses, survival analysis, 
regression modeling, and other appropriate statistical methods will be used to analyze the 
data. Specifically: 
● Descriptive statistics: Frequencies, means, medians, standard deviations, and ranges 
will be used to summarize patient demographics, clinical characteristics, 
intraoperative variables (e.g., docking time, operative time, blood loss, system 

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configuration, alarms), and postoperative outcomes (e.g., length of stay, complication 
rates by Clavien-Dindo classification). 
● Comparative effectiveness analyses: Will be performed to compare outcomes 
between different patient subgroups, procedural techniques, or system settings within 
the registry cohort. 
● Survival analysis: Kaplan-Meier methods will be used to analyze time-to-event 
outcomes such as overall survival, disease-free survival, and time to recurrence. Cox 
proportional hazards regression modeling will be used to identify predictors of these 
outcomes, adjusting for potential confounders. 
● Regression modeling: Logistic regression (for binary outcomes like complications) 
and linear regression (for continuous outcomes) will be used to explore relationships 
between patient/procedural factors and outcomes, and to control for confounding 
variables. 
● Subgroup analyses: May be conducted based on type of surgical procedure, tumor 
stage, patient comorbidities, or other relevant factors to explore differential effects of 
the Hugo RAS system. 
● Management of missing data: Appropriate methods for handling missing data (e.g., 
multiple imputation, sensitivity analyses based on different assumptions for missing 
data) will be considered and documented. 
● Sensitivity analyses: May be conducted to assess the robustness of the findings to 
variations in analytical assumptions. 
● Cost-effectiveness analysis: Specific methodologies will be applied to analyze data 
on cost-effectiveness as planned for Year 3. 
4.11.2 Risk factors, confounders and effect modifiers 
The following variables will be collected and considered in the analysis as potential 
exposures/risk factors, predictors, confounders, or effect modifiers: 
● Patient-related factors:  
o Demographics: Age, sex, Body Mass Index (BMI), race/ethnicity, 
socioeconomic status (Data source: eCRF from patient records). 
o Medical History: Comorbidities (e.g., Charlson Comorbidity Index), previous 
abdominal surgeries, current medications (Data source: eCRF from patient 
records/interviews). 
o Indication for Surgery: Specific diagnosis (e.g., colorectal cancer, 
diverticulitis, IBD), underlying disease details (e.g., tumor stage – TNM, 
inflammation severity – e.g., endoscopic scores for IBD) (Data source: eCRF 
from pathology, imaging, clinical records). Diagnostic criteria will be based on 
standard international guidelines for each condition. 
● Procedure-related factors:  
o Technical Setup: Docking time, system configuration (number of arms, 
specific instruments used), setup time, module usage (Data source: eCRF from 
surgical team input/operative log). 
o Surgical Procedure: Specific surgical techniques employed (e.g., type of 
resection, anastomosis technique, extent of lymph node dissection), use of 
advanced technologies (e.g., fluorescence imaging) (Data source: eCRF from 
operative log). 
o System Performance: Intraoperative conflicts of the robotic arms, occurrence 
and reason for alarms (including red alarms), any technical difficulties 
encountered (Data source: eCRF from surgical team input). 

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● Center-related factors: (e.g., center volume, surgeon experience with Hugo RAS – to 
be considered if data available). 
4.11.3 Policy for sharing data with other researchers/research groups (data sharing)  
Findings from the registry will be disseminated through peer-reviewed publications, conference 
presentations, and registry reports to participating centers. Periodic online meetings and 
updates will be provided to share analysis updates and key findings with participating 
centers. Requests for access to anonymized individual patient-level data by researchers 
external to the Hugo RAS Colorectal Collaborative (HRCC) steering committee will be 
considered on a case-by-case basis by the HRCC steering committee. A formal data 
sharing agreement outlining the terms of use, data security, and publication policies would 
be required. The primary aim is to protect patient confidentiality and ensure data is used 
responsibly for advancing scientific knowledge in line with the registry's objectives. 

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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 patient 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 
Trained medical personnel (e.g., surgeons, research nurses/coordinators) at each participating 
center will be responsible for providing patients with complete information about the study and 
for obtaining written informed consent and consent for data processing. Consents will typically 
be acquired at the outpatient colorectal surgery clinics or inpatient wards of the participating 
surgical units, prior to the surgical procedure. 
5.1.2 Study phase during which consents will be obtained 
Screening 
☒  
Baseline 
☒  
First follow-up visit 
 ☒ 
 
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  
● 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. 
 

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5.4.1 Strategies for the dissemination of results and for the reproducibility 
of research 
Findings from the registry will be disseminated through multiple channels: 
● Peer-reviewed publications: Targeting high-impact surgical and oncological 
journals. Initial findings are planned for publication starting Year 2, with subsequent 
papers on cost-effectiveness and long-term outcomes. 
● Conference presentations: Presenting research at major national and international 
surgical conferences. 
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 
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Feingold DL, Lightner AL, Paquette IM. Clinical practice guidelines for enhanced 
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Epub 2022 Dec 14. PMID: 36515747; PMCID: PMC9839829. 
2- Cheng CL, Rezac C. The role of robotics in colorectal surgery. BMJ. 2018 Feb 
12;360:j5304. doi: 10.1136/bmj.j5304. PMID: 29440057. 
3- Rottoli M, Violante T, Calini G, Cardelli S, Novelli M, Poggioli G. A multi-docking 
strategy for robotic LAR and deep pelvic surgery with the Hugo RAS system: 
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4- Ng KT, Tsia AKV, Chong VYL. Robotic Versus Conventional Laparoscopic Surgery 
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7. PMID: 30610272. 
5- Romero-Marcos JM, Sampson-Dávila JG, Cuenca-Gómez C, Altet-Torné J, 
González-Abós S, Ojeda-Jiménez I, Galaviz-Sosa ML, Delgado-Rivilla S. Colorectal 
procedures with the novel Hugo™ RAS system: training process and case series 
report from a non-robotic surgical team. Surg Endosc. 2024 Apr;38(4):2160-2168. 
doi: 10.1007/s00464-024-10760-8. Epub 2024 Mar 6. PMID: 38448626.