Study of Robotic-Assisted Surgery Using the da Vinci System for Gynecological Disorders in Adult Women A Prospective, Observational, Multi-Center Post Market Clinical Study

What this Trial Is About

This research aims to generate real-world evidence about the use of the da Vinci Surgical Systems for gynecological procedures within the German healthcare system. It is a prospective, non-interventional, multi-center, post-market clinical study focused on women with gynecological disorders who are candidates for robotic-assisted surgery. Participants are enrolled consecutively if they are undergoing robotic-assisted surgery with the da Vinci system or if they are eligible for robotic surgery but receive a non-da Vinci surgical procedure. The study collects data on these two groups to compare outcomes related to their surgical treatment choices. During the study, researchers will monitor complications related to surgery up to 30 days and patient-reported outcomes up to 12 months. They will also examine treatment decisions as reported by physicians. Additional measures include assessing the impact of patient characteristics and surgeon experience on outcomes and complications, patient quality of life and function, recurrence rates, and surgical details. Participants will be observed through follow-up visits and data collection lasting up to 12 months after surgery.

GENERATE - Next GENERATion of GynEcological Surgery - Robotic Assisted Surgery in Gynecological Indications