Comparing robotic platforms for gastric surgery
Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy (COMPAR-G) in Gastric Cancer Patient.
This study is testing three different robotic systems for stomach surgery to see which one works best and is easiest for surgeons to learn.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Verona) |
| Trial ID | NCT06362070 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the outcomes of robotic-assisted gastrectomy using three different surgical platforms: Da Vinci, Hugo, and Versius. The study is divided into two phases; the first assesses the feasibility of performing gastrectomy with the new platforms compared to the standard Da Vinci system. The second phase focuses on comparing the learning curves for surgeons experienced in laparoscopic surgery but new to robotic techniques. The trial aims to identify differences in intra-operative and post-operative complications, as well as technical and economic outcomes among the platforms.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a primary stomach tumor requiring total or subtotal gastrectomy.
Not a fit: Patients with metastatic gastric cancer or those requiring esophagectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and recovery for patients undergoing gastrectomy for gastric cancer.
How similar studies have performed: While robotic surgery has been widely adopted in various fields, this specific comparison of new robotic platforms in oncological gastric surgery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 and \< 80 years * Informed consent provided * Primary stomach tumor * Total or subtotal gastrectomy * Tumour stage: T1-4a, any N, M0 * ASA I-III * No BMI limits * Upfront surgery or after neoadjuvant chemotherapy Exclusion Criteria: * Extension to esophagectomy * Tumor of the esophago-gastric junction (Siwert I-III) * Emergency surgery * Metastatic patients (stage IV) * Patients undergoing preoperative radiotherapy * Previous major supramesocolic surgery (excluding cholecystectomy) * Other coexisting malignant neoplasms
Where this trial is running
Verona
- General and Upper GI Unit — Verona, Italy (Recruiting)
Study contacts
- Study coordinator: Simone SG Giacopuzzi, MD, Prof
- Email: simone.giacopuzzi@univr.it
- Phone: +39 0458127510
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.