跳至主要内容
临床试验/NCT06512480
NCT06512480招募中不适用

Implementation in Colorectal Surgery of a New Modular and Open Robotic Platform.Pilot Project.

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
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).

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

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).

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Sánchez Romero

GENERAL AND DIGESTIVE SURGEON

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

研究点 (1)

Loading locations...

相似试验