Colorectal Surgery, a New Robotic Platform (Hugo Ras)

NCT06512480 | Recruiting

• 1 other identifier: COLOROBOT-ELX24
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Surgery

Keywords

Robotic surgery; colorrectal surgery; Hugo™ RAS system; Surgical Innovations

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (1)

PATIENTS UNDERGOING HUGO RAS COLORECTAL RESECTION

Patients will undergo colonic or colorectal resection with the Hugo RAS robotic platform.

Procedure: colonic resection

Interventions

colonic resection PROCEDURE

colonic resection with the Hugo RAS robotic platform.

PATIENTS UNDERGOING HUGO RAS COLORECTAL RESECTION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Pacientes con indicación oncológica o de resección colónica.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: lead

Study Sites (1)

General University Hospital of Elche

Elche, Alicante, 03203, Spain

RECRUITING

Related Publications (8)

• 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.

  PMID: 35756633 BACKGROUND

• 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.

  PMID: 36897505 RESULT

• 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.

  PMID: 38448626 RESULT

• 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.

  PMID: 37395314 RESULT

• 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.

  PMID: 38154867 RESULT

• 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.

  PMID: 38980596 RESULT

• Arroyo 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.

  PMID: 41571968 DERIVED

• Arroyo 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.

  PMID: 39289218 DERIVED

Central Study Contacts

ANA SANCHEZ ROMERO

CONTACT

+34609609248; asromero1976@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: GENERAL AND DIGESTIVE SURGEON

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: July 9, 2024
• Primary Completion: July 9, 2025
• Study Completion (Estimated): July 9, 2027
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)