Implementation in Colorectal Surgery of a New Modular and Open Robotic Platform.Pilot Project.
Conditions: Colorectal Surgery
Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

 
STUDY PROTOCOL 
 
“IMPLEMENTATION IN COLORECTAL SURGERY OF A 
NEW MODULAR AND OPEN ROBOTIC PLATFORM. 
PILOT PROJECT" 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Versión: 1.0 (1/4/2024) 
 

Programa Doctorado en Salud Pública, Ciencias Médicas y Quirúrgicas.  
Plan de investigación. 
 
Ana M. Sánchez Romero 
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1. JUSTIFICATION OF THE NEED FOR THE PROJECT: 
 
General Surgery has experienced significant advancements in recent 
decades, driven by scientific research and technological innovation. These 
progressions have transformed surgical care, improving both the efficacy of 
procedures and patient outcomes. The continuous pursuit of safer and more 
efficient surgical methods has led to the implementation of new technologies, 
advanced surgical techniques, and multidisciplinary approaches. These 
advancements aim not only to increase the precision and efficacy of procedures 
but also to minimize associated risks and expedite patient recovery.  
Minimally invasive surgical techniques (MIST) have undergone substantial 
expansion in recent years, representing a transformative paradigm in general 
surgery. These methodologies, which include laparoscopy and other forms of 
minimally invasive approaches, have become preferred options due to their 
significant benefits in terms of recovery, reduced hospital stay, and lower 
postoperative morbidity. 
Surgical robotics has emerged as an exciting frontier in General Surgery, 
highlighting the convergence of engineering and medicine to enhance the 
precision and efficacy of surgical procedures. The continuous evolution of this 
technology has led to significant improvements across various surgical 
disciplines. The application of robotics in colorectal surgery has transformed the 
approach to pathologies in the gastrointestinal tract. The ability of robotic systems 
to provide three-dimensional vision and tools that replicate human hand 
movements has improved precision in dissection and suturing in complex 
anatomical areas. Recent studies (Smith et al., 2021) have highlighted the 

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reduction in complication rates and accelerated postoperative recovery 
compared to conventional approaches. 
The continuous evolution of MIST includes the development of robotic platforms 
and advanced visualization technologies, further expanding their scope and 
applicability. Current studies (López et al.) emphasize the importance of 
specialized training to maximize the benefits of these techniques and ensure 
patient safety.  
 
We propose an innovative project considering the ongoing transformation 
that General Surgery is experiencing, driven by technological advances, 
research, and interdisciplinary collaboration. The incorporation of technologies 
such as surgical robotics, augmented reality, and artificial intelligence is 
redefining surgical practice by enhancing precision, efficiency, and the ability to 
address complex procedures. 
The Hugo RAS platform represents the next generation in robotic technology, 
with potential improvements in instrument manipulation precision and three-
dimensional visualization quality. These advances can facilitate the execution of 
complex surgical techniques, particularly in confined spaces typical of colorectal 
surgery. 
 
We believe that the incorporation of the Hugo RAS platform in colorectal 
surgery represents a promising frontier in improving surgical care. This research 
project aims to provide a solid evidence base that will enable hospitals and 
healthcare systems to make informed decisions regarding the adoption of this 
technology. 
 
 

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2. HYPOTHESIS 
The implementation of a new modular and open robotic platform in 
colorectal surgery meets the standards of efficiency, safety and surgical results 
recommended by the Spanish Association of Coloproctology (AECP). 
3. GOALS 
3.1. MAIL GOAL 
 
Evaluate the results of a modular and open robotic platform (System of 
robotic-assisted surgery (RAS) Hugo™) in colorectal surgery (CRC) by 
complying with the quality indicators recommended by the Spanish Association 
of Coloproctology (AECP). 
- Surgical site infection for rectal cancer. 
- Surgical site infection for colon cancer. 
- Anastomotic dehiscence/leak (AF). 
- Mortality. 
- Readmissions. 
- Evisceration. 
- Reintervention. 
- Post-surgical hospital stay. 
- Circumferential margin in rectal cancer Quality of the mesorectum in rectal 
cancer. 
3.2. SECONDARY GOALS 
 
● To evaluate the degree of compliance with the application of multimodal 
rehabilitation protocols (Enhance Recovery After Surgery, ERAS) in patients 
undergoing colorectal robotic surgery. 

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● Analyze the surgeons' learning curve, operative time and complications in the 
use of the modular robotic platform for colorectal surgery. 
● Investigate the impact of colorectal robotic surgery on ergonomics and the 
prevention of musculoskeletal injuries related to surgical practice using surveys 
and validated neuromuscular injury scales. 
● Develop robust education and training programs for surgeons, nurses and 
technical staff, ensuring a smooth transition to the use of robotic surgery. 
● Assess patient satisfaction, including perception of quality of care, recovery 
process, and comparison of experiences between robotic surgery and other 
approaches using SF-36 quality of life surveys. 
 
4. MATERIAL AND METHODS 
 
A prospective, single-center and observational study is proposed with 
patients undergoing scheduled surgery since January 2024, of procedures in 
abdominal colorectal surgery with a robotic platform, in the Coloproctology Unit 
of the General Surgery and Digestive System Service of the General University 
Hospital of Elche.  
Patients will be operated on by surgeons with extensive experience in advanced 
laparoscopic colorectal surgery using the Hugo™ robot-assisted surgery (RAS) 
system.  
The Hugo™ RAS System is an open, portable, modular platform designed for a 
wide range of surgical procedures. Combines familiar surgical instruments such 
as a Valleylab™FT10 electroscalpel and advanced Full HD 3D laparoscopic 

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visualization with open console Karl Storz™ vision, with high-definition goggles 
with head-tracking safety system, with easy maneuvering through controls 
ergonomic pistol-type manuals that provide a comfortable and ergonomic grip for 
the surgeon, a system tower, 4 independent, mobile and extendable arms, a 
vision carriage that allows optimizing each of the procedures and a powerful 
surgical video recording option in Touch Surgery™ Enterprise with dedicated 
support teams specialized in optimizing robotic programs and training. The 
surgeon can move the robotic platform as needed and choose the best surgical 
approach for the characteristics and type of surgical procedure, even in patients 
with complex physical conditions, such as increased BMI, previous abdominal 
surgery and anatomical variability. The modular configuration of the four 
independent arm carts can allow modifications in the setup of the robotic trocars 
of the procedures by having a larger and more efficient work space in the 
operating room, avoiding unexpected system failures due to instrument collisions. 
The quality indicators recommended by EFCA will be used (ANNEX 1). 
 
 
4.1. Inclusion criteria 
- Patients undergoing scheduled abdominal colorectal surgery procedures (colon 
neoplasia, rectal neoplasia, diverticulosis, intestinal resection, transanal 
minimally invasive surgery (TAMIS), with the Hugo™ RAS robotic platform, under 
multimodal rehabilitation protocols (ERAS protocols).  
- Age greater than or equal to 18 years. 
 
 
 

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4.2 Criterios de exclusion 
 
- Patients operated on through an initial laparoscopic or open approach. 
- Urgent colorectal resections. 
- Patients under 18 years of age. 
- Existence of other concomitant surgical processes. 
- Severe cognitive impairment that makes patient collaboration impossible. 
- Patients diagnosed in oncological stage IV. 
- Patients who refuse to participate 
 
4.3 Recogida de datos 
 
The data will be collected by the surgery team and researchers. It will be 
included in a computer database anonymously. Clinical and demographic data 
will be collected from each patient through their computerized clinical history, 
creating a notebook and analyzed variables like: 
▪ Demographic variables: sex, date of birth, underlying pathology that the 
patient 
presents 
(cardiovascular 
risk 
factors, 
obesity, 
chronic 
medications), preoperative analytical values. 
▪ Operative data: date of intervention, ASA irrigation, type of intervention, 
approach, type of resection performed, associated procedures, type of 
anastomosis 
(location, 
technique, 
disposition), 
intraoperative 
complications (bleeding, intestinal perforation, medical complications), 
times operative (T1, T2, T3, T4). 
▪ Robotic platform data: 0º/30º camera, set up, set up modifications  

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▪ Surgeon information: colorectal surgeon, resident. 
▪ Postoperative complications: classification according to Clavien-Dindo 
Index, presence of anastomotic leak and its management, perioperative 
mortality.  
▪ Postoperative trocar pain (VAS scale). 
▪ Hospital stay. 
▪ Oncological variables: tumor location and stage according to TNM 2017 
(8th ed, AJCC12) preoperative and postoperative, neoadjuvant and 
adjuvant treatment. 
▪ Follow-up: complications recorded prospectively at 60 days through 
periodic visits to the coloproctology clinic, taking the annual review 
consultation as the end of follow-up for the patient within the study. The 
number of consultations during the first year, recurrence (indicating date 
and management) and death will be assessed. Oncological follow-up will 
be performed with control of tumor markers (CEA), control imaging tests 
(CT that combines PET/CT in case of suspected recurrence or metastasis) 
and biopsy in case of suspicion. 
4.4. Definitions: 
▪ Draping robot or T1: prepare the robot for surgery. It included connecting all 
the necessary parts such as sterile drapes and connectors needed for the surgery 
and also the calibration process. These steps are performed by a core team of 
scrub nurses specifically trained in handling the robot while the patient prepares 
for surgery. 

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▪ Docking time or T2: starts with the first order to position the first arm towards 
the patient until the last arm. It includes correct positioning of the robot, 
connecting the robotic arms to the trocars, and installing the robotic instruments 
and camera. 
▪ Console Time or T3: This represents the actual surgical intervention performed 
from the console by the primary surgeon. This period includes associated 
procedures. 
▪ Final Time or T4: Defined as the time from the initiation of trocar removal to the 
completion of skin closure. 
▪ Conversion to Laparoscopic or Open Surgery: This refers to the process of 
switching from a robotic surgical approach to laparoscopic or open surgery due 
to technical difficulties, intraoperative complications, or other reasons. This 
transition may involve the removal of the robot and the continuation of the 
procedure using conventional techniques. 
▪ Anastomotic Leak: Leakage of intraluminal content through the anastomosis 
forming an adjacent collection diagnosed via: CT scan (computed tomography), 
abdominal drainage with output of intestinal content or gas, endoscopy, or 
intraoperatively if the patient requires an unplanned reoperation of any type and 
for any reason. 
▪ Superficial Surgical Site Infection: Purulent drainage through the incision, 
local temperature increase with erythema. 
▪ Deep Surgical Site Infection: Purulent drainage through the incision 
originating from deeper layers, or the presence of a local abscess, spontaneous 

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wound dehiscence or dehiscence performed by the surgeon with a positive 
culture, or associated fever or local pain. 
▪ Organ-Space Infection: Involves any part of the body that was manipulated 
during the surgical procedure, except for the skin, fascia, and muscle wall, 
presenting with purulent output through intracavitary drainage, positive cultures, 
abscess, or infection diagnosed through invasive procedures or imaging tests. 
▪ Anastomotic Bleeding: There is no standard definition of anastomotic 
bleeding. For this record, the following principles based on the work published by 
Golda T et al., with slight modifications to their definitions, will be used: a) fresh 
bleeding per anus with hemodynamic compromise of the patient; b) passage of 
blood per anus for at least three consecutive days in the presence of normal 
bowel movements; c) passage of blood per anus occurring at least 48 hours after 
the patient has had normal bowel movements; or d) presence of blood per anus 
in any form that delays the patient's discharge for monitoring. 
▪ Local Recurrence: A lesion suspected of being of tumor origin following 
curative resection at the level of the anastomosis, mesentery, lymph nodes, or 
retroperitoneal area. 
▪ Disseminated Peritoneal Recurrence: The presence of oncological disease 
at the peritoneal level, either single or multifocal, which is clearly recognizable 
and distinguishable from other forms of locoregional recurrence of colon cancer, 
such as anastomotic, mesenteric, or lymph node recurrence, and retroperitoneal 
forms. 
▪ Measurement of Postoperative Pain from Robotic Trocars: This is the 
evaluation and quantification of pain experienced by the patient at the sites of 

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insertion of robotic trocars used during surgery. This measurement can be 
performed using pain assessment scales, such as the Visual Analog Scale (VAS) 
or the Numeric Pain Rating Scale (NPRS), to record the intensity and duration of 
postoperative pain. 
 
4.5. Data Management 
Data management and handling will be conducted by the Principal Investigator 
and collaborators. The data will be obtained from the patient's electronic medical 
records at the center and computerized clinical documentation systems. 
Data collection will be performed through the online office platform 
https://atenea.fisabio.san.gva.es/redcap/redcap_v13.8.5/index.php?pid=1083 
following the variable schema of the data collection notebook. This platform will 
securely and encryptedly store the records during the study period and for several 
years thereafter.  
The data may be used for future research, but since it is anonymous, patients will 
not be individually identifiable in the future. 
 
4.6. Local Ethics Committee 
 
Ethical approval was obtained from the ethical committee of the General 
University Hospital of Elche (PI 60/2024). 
 
 
 
 
 
 

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5. ETHICAL 
AND 
LEGAL 
ASPECTS. 
PROTECTION 
OF 
PARTICIPATING SUBJECTS. 
 
Benefit-risk assessment: 
Participants will not receive any direct personal benefit from participating in the 
study. Although the results could provide benefit in the scientific field and in the 
evolution and research on robotic surgery in the field of colorectal surgery in the 
future. There are no risks since this is a study of a surgical procedure in routine 
clinical practice in which data will be collected prospectively. 
 
Information to subjects and informed consent 
This study will be carried out in accordance with the Declaration of Helsinki on 
ethical principles for medical research in human subjects, which has its origin in 
the current revision (revised version of Fortaleza, 2013) approved by the World 
Medical Assembly, the Oviedo Convention, and with the current regulatory 
requirements included in the specific Spanish legislation: order SAS 3470/2009).  
There are no financial compensations for participating subjects provided for in 
this study. 
Ethical approval was obtained from the ethical committee of the General 
University Hospital of Elche (PI 60/2024). 
The rights, safety and well-being of study patients are the most important 
considerations and must take precedence over the interests of science and 
society. 
Study personnel involved in conducting this trial will be qualified by education, 
training and experience to perform their corresponding tasks. 
 

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An informative document, Patient Information Sheet and informed consent will be 
given to patients who are offered to participate in the study. To be included in the 
study, you must submit it signed and thus accepting the processing of your data 
and participation. 
Data confidentiality: 
The processing, communication and transfer of personal data of all participating 
subjects will comply with the current Organic Law 3/2018 of December 5, on the 
Protection of personal data and guarantee of digital rights, adopting the 
Regulation (EU) 2016/679 of the European Parliament and of the Council, of April 
27, 2016 on the protection of natural persons with regard to the processing of 
their personal data and the free circulation of these data and repealing Directive 
95 /46/EC (General Data Protection Regulation), as well as Directive (EU) 
2016/680 of the European Parliament and of the Council, of April 27, 2016, on 
the protection of natural persons with regard to the processing of personal data 
by the competent authorities for the purposes of prevention, investigation, 
detection or prosecution of criminal offenses or the execution of criminal 
sanctions, and to the free circulation of such data and repealing Framework 
Decision 2008/977 /JHA of the Council. 
The data collected for the study will be identified by a code, so that it does not 
include 
information 
that 
could 
identify 
you, 
and 
only 
your 
study 
doctor/collaborators will be able to relate this data to you and your medical 
history. Therefore, your identity will not be revealed to anyone except in cases of 
medical emergency or legal requirement. The treatment, communication and 
transfer of personal data of all participants will comply with the provisions of this 

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law. This study meets all the requirements regarding privacy of personal data. 
Any subsequent publication of the results will never show the patient's personal 
data. 
The data will be collected in an online database on the RedCap platform to 
establish a single and common research record under the responsibility of the 
institution and will be processed within the framework of your participation in this 
study. 
Transfer of data to foreign countries: Compliance with national regulations 
regarding the transfer of data obtained from the study will always be required.  
According to the mentioned Law, the consent for the processing of your personal 
data and for its transfer is revocable. Therefore, at any time you can exercise 
your right of access, rectification, opposition and cancellation of your data by 
contacting the Secretary of General Surgery and the Digestive System by calling 
+34966616377 during morning hours. 
Monitoring, audits, ethical committee reviews and regulatory inspections related 
to the study will be allowed, facilitating direct access to the original 
documents/data. 
The principal investigator (PI) is responsible for maintaining an up-to-date record 
of subjects. This record will be kept in the strictest confidentiality at the study 
center, so that only the researcher and other members of the research team will 
have complete knowledge of the subject's identity. 
 
 
 
 
 
 

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Publications: 
All information from the study will be considered confidential. The principal 
investigator assumes the set of responsibilities linked to this function, and the 
exclusive ownership of the results of the study, which may be freely exploited, 
committing to publish the results of the study in a scientific journal or to make 
them available to the public as established by the Declaration of Helsinki in point 
27: “Both authors and editors have ethical obligations. When publishing the 
results of his research, the doctor is obliged to maintain the accuracy of the data 
and results. Both negative and positive results must be published or otherwise 
made available to the public. The publication must cite the source of funding, 
institutional affiliations and any conflict of interest.” 
This Research Project has the Favorable Report of the Clinical Research Ethics 
Committee of the Center of the Principal Investigator (General University Hospital 
of Elche). Any other recommendations of the Committee will be taken into 
account in order to improve the procedure. 
 
 
 
 
 
 
 
 
 

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ANNEX 1. QUALITY INDICATORS RECOMMENDED BY THE SPANISH 
ASSOCIATION OF COLOPROCTOLGY (AECP) 
 https://acredita-aecp.com/help/Manual-acreditacion-AECP.pdf 
 

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