Colorectal SurgeryNCT06512480
Colorectal Surgery, a New Robotic Platform (Hugo Ras)
An observational study of Colorectal Surgery, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
Trial summary
A novel robotic platform -Hugo Robotic Assisted Surgery (RAS)- has been introduced with several innovations that may prove advantageous for surgeons such as an open console and four interchangeable modular arms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- colonic resection
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 9 Jul 2024to 9 Jul 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pacientes con indicación oncológica o de resección colónica.
Who may be able to join
- Pacientes intervenidos de forma programada de procedimientos en cirugía colorrectal abdominal (neoplasia de colon, neoplasia de recto, diverticulosis, resección intestinal, cirugía transanal mínimamente invasiva (TAMIS), con la plataforma robótica Hugo™ RAS, en régimen de protocolos de rehabilitación multimodal (protocolos ERAS) (ANEXO 2).
- Edad mayor o igual a 18 años.
Who cannot join
- Pacientes intervenidos mediante abordaje inicial laparoscópico o abierto.
- Resecciones colorrectales de carácter urgente.
- Pacientes menores de 18 años.
- Existencia de otros procesos quirúrgicos concomitantes.
- Deterioro cognitivo severo que imposibilita la colaboración del paciente.
- Pacientes diagnosticados en estadio IV oncológico.
- Pacientes que rechacen participar
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
General University Hospital of Elche
Elche, Alicante, 03203
ANA SANCHEZ ROMERO, asromero1976@gmail.com
ANA SANCHEZ ROMERO
About this study
Official title: Implementation in Colorectal Surgery of a New Modular and Open Robotic Platform.Pilot Project.
A novel robotic platform -Hugo Robotic Assisted Surgery (RAS)- has been introduced with several innovations that may prove advantageous for surgeons such as an open console and four interchangeable modular arms. Our study aims to evaluate the safety, efficacy and potential impact of this platform in the surgical treatment of colorectal pathology.
Read the detailed description
A case series underwent robotic-assisted colorectal procedures with the Hugo™ RAS system in General University Hospital of Elche, a referral center for colorectal surgery with extensive experience in laparoscopic surgery and none in robotics, from October 2023.No specific exclusion criteria were applied for patient selection. 2 surgeons and 1 nurse had previously completed the technical training [9] on the platform. The data were included in a computer database anonymously. For each patient, demographic, clinical and perioperative data, intraoperative robotics platform details, postoperative complications, length of hospital stay, tumor stage (TNM), and follow-up at one month were collected. For statistical analysisSPSS version 29.0 was used . In the descriptive analysis, the appropriate estimators have been used according to the type of variables: means or medians, standard deviation or ranges, for the quantitative variables, and percentages for qualitative variables.
Ethical approval was obtained from the ethical committee of the General University Hospital of Elche (PI 60/2024).
This study will be conducted in accordance with the Declaration of Helsinki on ethical principles for medical research on human subjects, which has its origin in the current review (revised version of Fortaleza, 2013) approved by the World Medical Assembly, the Oviedo Convention, and with the requirements current regulators included in the specific Spanish legislation: SAS order 3470/2009).
The rights, safety and well-being of study patients are the most important considerations to take into account and should prevail on the interests of science and society.
An informative document, Patient Information Sheet and Informed consent to patients to whom it is offered 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.
The processing, communication and transfer of personal data of all The participating subjects will comply with the current Organic Law 3/2018 of 5 December, Protection of personal data and guarantee of rights digital, adopting Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 on the protection of natural persons regarding the processing of your personal data and free circulation of these data and which repeals Directive 95/46/EC (General Regulation data protection), as well as Directive (EU) 2016/680 of the Parliament European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by of the competent authorities for the purposes of prevention, investigation, detection or prosecution of criminal offenses or execution of sanctions criminal offenses, and the free circulation of said data and repealing the Decision Framework 2008/977/JHA of the Council. The data collected for the study will be identified by a code, so in a manner that does not include information that could identify you, and only your doctor studio/collaborators may relate said data to you and your history clinic. Therefore, your identity will not be revealed to anyone except exceptions in case of medical emergency or legal requirement. The treatment, the communication and transfer of personal data of all Participants will comply with the provisions of this law. This study meets all the requirements regarding privacy of personal data. All Subsequent publication of results will never show data patient's personal. The data will be collected in an online database on the RedCap platform to establish a single and common registry of investigation responsibility of the institution and will be discussed within the framework of your participation in this study.
- Conditions
- Colorectal Surgery
- Being tested
- colonic resection
- Keywords
- Robotic surgery, colorrectal surgery, Hugo™ RAS system, Surgical Innovations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonic resectionProcedure or surgery
colonic resection with the Hugo RAS robotic platform.
| Study group | Role | What they receive |
|---|---|---|
| PATIENTS UNDERGOING HUGO RAS COLORECTAL RESECTION | Patients will undergo colonic or colorectal resection with the Hugo RAS robotic platform. Receives: Procedure: colonic resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
In the descriptive analysis, the appropriate estimators will be used according to the type of variables: means or medians, standard deviation (SD) or ranges, for the quantitative variables, and percentages (%) for qualitative variables. In the analysis bivariate, the Chi-square test will be used for qualitative variables, and for the quantitative variables the Student's t test if the distribution is normal and the Mann-Whitney U when such normality cannot be assumed (the normal distribution of the variables will be analyzed using the test of Kolmogorov-Smirnov).
In all estimates, 95% confidence intervals will be calculated and a p value less than 0.05 will be considered significant.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start9 Jul 2024
- Primary completion9 Jul 2025 (estimated)
- Study completion9 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Sánchez Romero, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512480
- Sponsor's protocol ID
- COLOROBOT-ELX24
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gueli Alletti S, Chiantera V, Arcuri G, Gioe A, Oliva R, Monterossi G, Fanfani F, Fagotti A, Scambia G. Introducing the New Surgical Robot HUGO RAS: System Description and Docking Settings for Gynecological Surgery. Front Oncol. 2022 Jun 9;12:898060. doi: 10.3389/fonc.2022.898060. eCollection 2022.
PubMed 35756633Bianchi PP, Salaj A, Rocco B, Formisano G. First worldwide report on Hugo RAS surgical platform in right and left colectomy. Updates Surg. 2023 Apr;75(3):775-780. doi: 10.1007/s13304-023-01489-5. Epub 2023 Mar 10.
PubMed 36897505Romero-Marcos JM, Sampson-Davila JG, Cuenca-Gomez C, Altet-Torne J, Gonzalez-Abos S, Ojeda-Jimenez 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.
PubMed 38448626Gangemi A, Bernante P, Rottoli M, Pasquali F, Poggioli G. Surgery of the alimentary tract for benign and malignant disease with the novel robotic platform HUGOTM RAS. A first world report of safety and feasibility. Int J Med Robot. 2023 Aug;19(4):e2544. doi: 10.1002/rcs.2544. Epub 2023 Jul 3.
PubMed 37395314Caruso R, Vicente E, Quijano Y, Ferri V. New era of robotic surgery: first case in Spain of right hemicolectomy on Hugo RAS surgical platform. BMJ Case Rep. 2023 Dec 28;16(12):e256035. doi: 10.1136/bcr-2023-256035.
PubMed 38154867Belyaev O, Fahlbusch T, Slobodkin I, Uhl W. Major colorectal surgery with Hugo RAS: initial experience of a German center and a review of the literature. Updates Surg. 2024 Sep;76(5):1705-1714. doi: 10.1007/s13304-024-01939-8. Epub 2024 Jul 9.
PubMed 38980596Arroyo A, Lopez-de-Lerma C, Perea M, Sanchez-Romero A, Lopez-Rodriguez-Arias F, Alcaide MJ, Serrano-Navidad M, Barber X, Miranda E, Munoz-Rodes JL, Sanchez-Guillen L. Functional, oncologic and clinical outcomes of robotic rectal resection using the Hugo RAS system versus laparoscopic surgery: A comparative cohort study. Int J Colorectal Dis. 2026 Jan 22;41(1):40. doi: 10.1007/s00384-025-05063-w.
PubMed 41571968Arroyo A, Sanchez-Romero A, Soler-Silva A, Quinto S, Lopez-Rodriguez-Arias F, Alcaide MJ, Serrano-Navidad M, Miranda E, Munoz JL, Sanchez-Guillen L. Utility guideline and considerations for the novel Hugo RAS (robotic-assisted surgery) system in colorectal surgery: surgical outcomes and initial experience in a tertiary center. Int J Colorectal Dis. 2024 Sep 18;39(1):144. doi: 10.1007/s00384-024-04715-7.
PubMed 39289218
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation in Colorectal Surgery of a New Modular and Open Robotic Platform.Pilot Project.
- ClinicalTrials.gov ID
- NCT06512480
- Acronym / sponsor ID
- COLOROBOT-ELX24
- Conditions
- Colorectal Surgery
- Keywords
- Robotic surgery, colorrectal surgery, Hugo™ RAS system, Surgical Innovations
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat ValencianaUniversity, hospital or other
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 9 Jul 2025 (estimated)
- Study completion
- 9 Jul 2027 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A novel robotic platform -Hugo Robotic Assisted Surgery (RAS)- has been introduced with several innovations that may prove advantageous for surgeons such as an open console and four interchangeable modular arms. Our study aims to evaluate the safety, efficacy and potential impact of this platform in the surgical treatment of colorectal pathology.
Detailed description
A case series underwent robotic-assisted colorectal procedures with the Hugo™ RAS system in General University Hospital of Elche, a referral center for colorectal surgery with extensive experience in laparoscopic surgery and none in robotics, from October 2023.No specific exclusion criteria were applied for patient selection. 2 surgeons and 1 nurse had previously completed the technical training [9] on the platform. The data were included in a computer database anonymously. For each patient, demographic, clinical and perioperative data, intraoperative robotics platform details, postoperative complications, length of hospital stay, tumor stage (TNM), and follow-up at one month were collected. For statistical analysisSPSS version 29.0 was used . In the descriptive analysis, the appropriate estimators have been used according to the type of variables: means or medians, standard deviation or ranges, for the quantitative variables, and percentages for qualitative variables.
Ethical approval was obtained from the ethical committee of the General University Hospital of Elche (PI 60/2024).
This study will be conducted in accordance with the Declaration of Helsinki on ethical principles for medical research on human subjects, which has its origin in the current review (revised version of Fortaleza, 2013) approved by the World Medical Assembly, the Oviedo Convention, and with the requirements current regulators included in the specific Spanish legislation: SAS order 3470/2009).
The rights, safety and well-being of study patients are the most important considerations to take into account and should prevail on the interests of science and society.
An informative document, Patient Information Sheet and Informed consent to patients to whom it is offered 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.
The processing, communication and transfer of personal data of all The participating subjects will comply with the current Organic Law 3/2018 of 5 December, Protection of personal data and guarantee of rights digital, adopting Regulation (EU) 2016/679 of the European Parliament and of the Council of April 27, 2016 on the protection of natural persons regarding the processing of your personal data and free circulation of these data and which repeals Directive 95/46/EC (General Regulation data protection), as well as Directive (EU) 2016/680 of the Parliament European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by of the competent authorities for the purposes of prevention, investigation, detection or prosecution of criminal offenses or execution of sanctions criminal offenses, and the free circulation of said data and repealing the Decision Framework 2008/977/JHA of the Council. The data collected for the study will be identified by a code, so in a manner that does not include information that could identify you, and only your doctor studio/collaborators may relate said data to you and your history clinic. Therefore, your identity will not be revealed to anyone except exceptions in case of medical emergency or legal requirement. The treatment, the communication and transfer of personal data of all Participants will comply with the provisions of this law. This study meets all the requirements regarding privacy of personal data. All Subsequent publication of results will never show data patient's personal. The data will be collected in an online database on the RedCap platform to establish a single and common registry of investigation responsibility of the institution and will be discussed within the framework of your participation in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PATIENTS UNDERGOING HUGO RAS COLORECTAL RESECTION | – | Procedure: colonic resectionPatients will undergo colonic or colorectal resection with the Hugo RAS robotic platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pacientes con indicación oncológica o de resección colónica.
Key inclusion criteria (2 listed)
- Pacientes intervenidos de forma programada de procedimientos en cirugía colorrectal abdominal (neoplasia de colon, neoplasia de recto, diverticulosis, resección intestinal, cirugía transanal mínimamente invasiva (TAMIS), con la plataforma robótica Hugo™ RAS, en régimen de protocolos de rehabilitación multimodal (protocolos ERAS) (ANEXO 2).
- Edad mayor o igual a 18 años.
Key exclusion criteria (7 listed)
- Pacientes intervenidos mediante abordaje inicial laparoscópico o abierto.
- Resecciones colorrectales de carácter urgente.
- Pacientes menores de 18 años.
- Existencia de otros procesos quirúrgicos concomitantes.
- Deterioro cognitivo severo que imposibilita la colaboración del paciente.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonic resectioncolonic resection with the Hugo RAS robotic platform. | Procedure or surgery | PATIENTS UNDERGOING HUGO RAS COLORECTAL RESECTION |
Primary outcome
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).
Time frame: 1 year
In the descriptive analysis, the appropriate estimators will be used according to the type of variables: means or medians, standard deviation (SD) or ranges, for the quantitative variables, and percentages (%) for qualitative variables. In the analysis bivariate, the Chi-square test will be used for qualitative variables, and for the quantitative variables the Student's t test if the distribution is normal and the Mann-Whitney U when such normality cannot be assumed (the normal distribution of the variables will be analyzed using the test of Kolmogorov-Smirnov). In all estimates, 95% confidence intervals will be calculated and a p value less than 0.05 will be considered significant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 35756633Gueli Alletti S, Chiantera V, Arcuri G, Gioe A, Oliva R, Monterossi G, Fanfani F, Fagotti A, Scambia G. Introducing the New Surgical Robot HUGO RAS: System Description and Docking Settings for Gynecological Surgery. Front Oncol. 2022 Jun 9;12:898060. doi: 10.3389/fonc.2022.898060. eCollection 2022.
- Results publication: PubMed 36897505Bianchi PP, Salaj A, Rocco B, Formisano G. First worldwide report on Hugo RAS surgical platform in right and left colectomy. Updates Surg. 2023 Apr;75(3):775-780. doi: 10.1007/s13304-023-01489-5. Epub 2023 Mar 10.
- Results publication: PubMed 38448626Romero-Marcos JM, Sampson-Davila JG, Cuenca-Gomez C, Altet-Torne J, Gonzalez-Abos S, Ojeda-Jimenez 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.
- Results publication: PubMed 37395314Gangemi A, Bernante P, Rottoli M, Pasquali F, Poggioli G. Surgery of the alimentary tract for benign and malignant disease with the novel robotic platform HUGOTM RAS. A first world report of safety and feasibility. Int J Med Robot. 2023 Aug;19(4):e2544. doi: 10.1002/rcs.2544. Epub 2023 Jul 3.
- Results publication: PubMed 38154867Caruso R, Vicente E, Quijano Y, Ferri V. New era of robotic surgery: first case in Spain of right hemicolectomy on Hugo RAS surgical platform. BMJ Case Rep. 2023 Dec 28;16(12):e256035. doi: 10.1136/bcr-2023-256035.
- Results publication: PubMed 38980596Belyaev O, Fahlbusch T, Slobodkin I, Uhl W. Major colorectal surgery with Hugo RAS: initial experience of a German center and a review of the literature. Updates Surg. 2024 Sep;76(5):1705-1714. doi: 10.1007/s13304-024-01939-8. Epub 2024 Jul 9.
- Derived from this study: PubMed 41571968Arroyo A, Lopez-de-Lerma C, Perea M, Sanchez-Romero A, Lopez-Rodriguez-Arias F, Alcaide MJ, Serrano-Navidad M, Barber X, Miranda E, Munoz-Rodes JL, Sanchez-Guillen L. Functional, oncologic and clinical outcomes of robotic rectal resection using the Hugo RAS system versus laparoscopic surgery: A comparative cohort study. Int J Colorectal Dis. 2026 Jan 22;41(1):40. doi: 10.1007/s00384-025-05063-w.
- Derived from this study: PubMed 39289218Arroyo A, Sanchez-Romero A, Soler-Silva A, Quinto S, Lopez-Rodriguez-Arias F, Alcaide MJ, Serrano-Navidad M, Miranda E, Munoz JL, Sanchez-Guillen L. Utility guideline and considerations for the novel Hugo RAS (robotic-assisted surgery) system in colorectal surgery: surgical outcomes and initial experience in a tertiary center. Int J Colorectal Dis. 2024 Sep 18;39(1):144. doi: 10.1007/s00384-024-04715-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Surgery, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ANA SANCHEZ ROMERO (+34609609248, asromero1976@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06512480, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024; AzTrials last refreshed its copy on 31 Oct 2026.