Clinical trial NCT06512480: Colorectal Surgery, a New Robotic Platform (Hugo Ras)
Official title: Implementation in Colorectal Surgery of a New Modular and Open Robotic Platform.Pilot Project.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Surgery
Keywords: Robotic surgery
colorrectal surgery
Hugo™ RAS system
Surgical Innovations
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Pacientes con indicación oncológica o de resección colónica.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
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).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Elche
country: Spain
facility: General University Hospital of Elche
state: Alicante
Study officials:
References:
citation: 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.
citation: Bianchi 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.
citation: Romero-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.
citation: Gangemi 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.
citation: Caruso 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.
citation: Belyaev 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.