Introducing the New Surgical Robot HUGO™ RAS: System Description and Docking Settings for Gynecological Surgery.
Salvatore Gueli Alletti, Vito Chiantera, Giovanni Arcuri...
https://pubmed.ncbi.nlm.nih.gov/35756633Actively Recruiting
Age: 18Years +
All Genders
ID06512480
Implementation in Colorectal Surgery of a New Modular and Open Robotic Platform. Pilot Project.
Led by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · Updated on 2024-07-23
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new robotic platform called Hugo Robotic Assisted Surgery (RAS) for use in colorectal surgery. This study aims to assess the safety, effectiveness, and overall impact of this innovative system, which features an open console and four interchangeable modular arms, in treating colorectal conditions. The study is conducted at a referral center experienced in laparoscopic colorectal surgery but new to robotic techniques. Patients will undergo planned colonic or colorectal resections using the Hugo RAS robotic platform. The surgical procedures include abdominal colorectal surgeries such as colon and rectal cancer, diverticulosis, intestinal resection, and minimally invasive transanal surgery (TAMIS) following enhanced recovery protocols (ERAS). The study includes a one-year follow-up period to monitor outcomes. Participants will have their demographic, clinical, surgical, and perioperative data collected and stored anonymously in a secure database. Researchers will track intraoperative details, postoperative complications, hospital stay length, tumor staging, and follow-up results at one month. The primary outcome is to evaluate the procedure results against quality indicators recommended by the Spanish Association of Coloproctology. Patient safety, privacy, and well-being are prioritized throughout the study, which complies with ethical and data protection regulations.
CONDITIONS
Brief Title
Colorectal Surgery, a New Robotic Platform (Hugo Ras)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients scheduled for planned abdominal colorectal surgery procedures using the Hugo RAS robotic platform, including colon and rectal cancer, diverticulosis, intestinal resection, and minimally invasive transanal surgery (TAMIS) under multimodal rehabilitation protocols (ERAS).
- Age 18 years or older.
You will not qualify if you...
- Patients who had an initial laparoscopic or open surgical approach.
- Urgent colorectal resections.
- Patients under 18 years of age.
- Presence of other simultaneous surgical procedures.
- Severe cognitive impairment preventing patient cooperation.
- Patients diagnosed with stage IV oncologic disease.
- Patients who refuse to participate.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Surgery and Immediate Post-operative Care
Duration - Hospital stay duration
Participants undergo colonic or colorectal resection using the Hugo RAS robotic platform followed by immediate post-operative care.
1 visit (in-person) for surgery and hospital stay
Post-operative Follow-up
Duration - 1 month
Participants are monitored for postoperative complications and recovery, including follow-up assessments at one month after surgery.
1 follow-up visit at one month
Trial Site Locations
Total: 1 location
1
General University Hospital of Elche
Elche, Alicante, Spain, 03203
Actively Recruiting
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Research Team
A
ANA SANCHEZ ROMERO
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
First worldwide report on Hugo RAS™ surgical platform in right and left colectomy.
Paolo Pietro Bianchi, Adelona Salaj, Bernardo Rocco...
https://pubmed.ncbi.nlm.nih.gov/36897505Colorectal procedures with the novel Hugo™ RAS system: training process and case series report from a non-robotic surgical team.
Juan-Manuel Romero-Marcos, Jaime-Gerardo Sampson-Dávila, Carlota Cuenca-Gómez...
https://pubmed.ncbi.nlm.nih.gov/38448626Surgery of the alimentary tract for benign and malignant disease with the novel robotic platform HUGOTM RAS. A first world report of safety and feasibility.
Antonio Gangemi, Paolo Bernante, Matteo Rottoli...
https://pubmed.ncbi.nlm.nih.gov/37395314New era of robotic surgery: first case in Spain of right hemicolectomy on Hugo RAS surgical platform.
Riccardo Caruso, Emilio Vicente, Yolanda Quijano...
https://pubmed.ncbi.nlm.nih.gov/38154867Major colorectal surgery with Hugo™ RAS: initial experience of a German center and a review of the literature.
Orlin Belyaev, Tim Fahlbusch, Illya Slobodkin...
https://pubmed.ncbi.nlm.nih.gov/38980596Functional, oncologic and clinical outcomes of robotic rectal resection using the Hugo™ RAS system versus laparoscopic surgery: A comparative cohort study.
Antonio Arroyo, Clara López-de-Lerma, María Perea...
https://pubmed.ncbi.nlm.nih.gov/41571968Utility guideline and considerations for the novel Hugo™ RAS (robotic-assisted surgery) system in colorectal surgery: surgical outcomes and initial experience in a tertiary center.
Antonio Arroyo, Ana Sánchez-Romero, Álvaro Soler-Silva...
https://pubmed.ncbi.nlm.nih.gov/39289218