Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512480
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Colorectal Surgery a New Robotic Platform Hugo Ras
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implementation in Colorectal Surgery of a New Modular and Open Robotic PlatformPilot Project
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 2023No 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 290 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 602024
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 34702009
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
The processing communication and transfer of personal data of all The participating subjects will comply with the current Organic Law 32018 of 5 December Protection of personal data and guarantee of rights digital adopting Regulation EU 2016679 of the European Parliament and of the Council of April 27 2016 on the protection of natural persons regarding the processing of your personal data and free circulation of these data and which repeals Directive 9546EC General Regulation data protection as well as Directive EU 2016680 of the Parliament European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by of the competent authorities for the purposes of prevention investigation detection or prosecution of criminal offenses or execution of sanctions criminal offenses and the free circulation of said data and repealing the Decision Framework 2008977JHA of the Council The data collected for the study will be identified by a code so in a manner that does not include information that could identify you and only your doctor studiocollaborators may relate said data to you and your history clinic Therefore your identity will not be revealed to anyone except exceptions in case of medical emergency or legal requirement The treatment the communication and transfer of personal data of all Participants will comply with the provisions of this law This study meets all the requirements regarding privacy of personal data All Subsequent publication of results will never show data patients personal The data will be collected in an online database on the RedCap platform to establish a single and common registry of investigation responsibility of the institution and will be discussed within the framework of your participation in this study
Ethical approval was obtained from the ethical committee of the General University Hospital of Elche PI 602024
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 34702009
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
The processing communication and transfer of personal data of all The participating subjects will comply with the current Organic Law 32018 of 5 December Protection of personal data and guarantee of rights digital adopting Regulation EU 2016679 of the European Parliament and of the Council of April 27 2016 on the protection of natural persons regarding the processing of your personal data and free circulation of these data and which repeals Directive 9546EC General Regulation data protection as well as Directive EU 2016680 of the Parliament European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by of the competent authorities for the purposes of prevention investigation detection or prosecution of criminal offenses or execution of sanctions criminal offenses and the free circulation of said data and repealing the Decision Framework 2008977JHA of the Council The data collected for the study will be identified by a code so in a manner that does not include information that could identify you and only your doctor studiocollaborators may relate said data to you and your history clinic Therefore your identity will not be revealed to anyone except exceptions in case of medical emergency or legal requirement The treatment the communication and transfer of personal data of all Participants will comply with the provisions of this law This study meets all the requirements regarding privacy of personal data All Subsequent publication of results will never show data patients personal The data will be collected in an online database on the RedCap platform to establish a single and common registry of investigation responsibility of the institution and will be discussed within the framework of your participation in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None