IDEAL-D Phase 0 Evaluation of the Avatera System in Robot-Assisted Prostate, Bladder and Renal Surgery.
J Laparoendosc Adv Surg Tech A
; 34(3): 239-245, 2024 Mar.
Article
em En
| MEDLINE
| ID: mdl-38252556
ABSTRACT
Purpose:
To evaluate the utilization of novel Avatera system in urological operations according to the IDEAL-D framework recommendations for high-risk invasive surgical devices. Materials andMethods:
Three surgeons attempted to perform 23 upper and lower urinary tract operations on human cadavers and in live porcine models using the Avatera system. Total operative time and the duration of the substeps were evaluated. Surgical performance was assessed with the Global Evaluative Assessment of Robotic Skills (GEARS) score. Suturing was rated using the technical checklist for the assessment of suturing in robotic surgery. Attending surgeons rated their satisfaction with the Avatera system on a scale of 1-5. Results andLimitation:
Seventeen out of 18 operations performed on cadavers were completed, while one pyeloplasty was discontinued. All five operations performed in porcine models were completed. Although 1 pig was euthanized on the fifth postoperative day, its symptoms were unrelated to surgery. Mean GEARS and Suturing scores in the upper urinary tract were 29 ± 0.7 and 29.5 ± 0.95, respectively, and in the lower urinary 28.5 ± 1.2 and 29.5 ± 0.5, respectively. Surgeons' satisfaction was high or very high for all procedures.Conclusions:
The Avatera system was associated with good surgical performance and high surgeons' satisfaction rates. All urological procedures performed were shown to be feasible, with comparable risks to other robot-assisted surgery systems.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Robótica
/
Procedimentos Cirúrgicos Robóticos
Tipo de estudo:
Prognostic_studies
Limite:
Animals
/
Humans
/
Male
Idioma:
En
Ano de publicação:
2024
Tipo de documento:
Article