Colorectal Surgery, a New Robotic Platform (Hugo Ras)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pacientes intervenidos mediante abordaje inicial laparoscópico o abierto.

Resecciones colorrectales de carácter urgente.

Pacientes menores de 18 años.

Existencia de otros procesos quirúrgicos concomitantes.

Trial population

Pacientes con indicación oncológica o de resección colónica.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • colonic resection

    Procedure/Surgery

    colonic resection with the Hugo RAS robotic platform.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: PATIENTS UNDERGOING HUGO RAS COLORECTAL RESECTION1 intervention

Trial outcomes

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.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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