Evaluating a new robotic platform for colorectal surgery
Implementation in Colorectal Surgery of a New Modular and Open Robotic Platform.Pilot Project.
This study is testing a new robotic surgery system to see if it can safely and effectively help patients undergoing colorectal surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana Academic / other |
| Locations | 1 site (Elche, Alicante) |
| Trial ID | NCT06512480 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the safety and efficacy of the Hugo Robotic Assisted Surgery (RAS) system in performing colorectal procedures. Conducted at the General University Hospital of Elche, the study involves a case series of patients undergoing scheduled colorectal surgeries, including various neoplasias and minimally invasive techniques. Data collected includes demographic, clinical, and perioperative information, as well as postoperative outcomes and complications. The analysis will utilize SPSS software to evaluate the results and ensure comprehensive statistical assessment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective colorectal surgeries using the Hugo RAS system.
Not a fit: Patients requiring urgent colorectal surgery or those with severe cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and recovery for patients undergoing colorectal surgery.
How similar studies have performed: While robotic surgery is an established field, this specific application of the Hugo RAS system is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Elche, Alicante
- General University Hospital of Elche — Elche, Alicante, Spain (Recruiting)
Study contacts
- Study coordinator: Ana Sanchez Romero
- Email: asromero1976@gmail.com
- Phone: +34609609248
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.