Clinical Trials in Spain / NCT06512480
Recruiting
Observational
Colorectal Surgery, a New Robotic Platform (Hugo Ras)
NCT06512480 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Colorectal Surgery
Investigational drug(s) / intervention(s)
colonic resection
colonic resection: colonic resection with the Hugo RAS robotic platform.
Study 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.
Eligibility
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 outcome measure(s)
- 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). — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| General University Hospital of Elche | Elche | Alicante | Recruiting |
More Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana trials in Spain
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Opioid-Free Anesthesia in Colorectal Surgery, 2025 (OFA-CRC-2025)
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06512480 on ClinicalTrials.gov ↗ ← All trials in Spain