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 volunteersQualifiers
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
Cohort
Other
Treatments tested in this trial
colonic resection
Procedure/Surgerycolonic resection with the Hugo RAS robotic platform.
Treatment groups
Trial outcomes
Primary outcomes
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.
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