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

Condition(s) studied

Investigational drug(s) / intervention(s)

Robotic-assisted surgery (da Vinci): Robotic-assisted surgery (da Vinci)

Non-da Vinci Surgery: Non-da Vinci Surgery

Study summary

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

Generate real-world evidence in the use of the da Vinci Surgical Systems for gynecological indications within the German health care system.

Eligibility

Primary outcome measure(s)

• Number of complications related to the surgery up to 30 days — 30 days
  Describe the number of complications related to the surgery up to 30 days; adverse events as documented during the first 30 days will be classified as four different levels of causality to the surgery (not related, possible, probable and causal relationship). Descriptive analysis will be performed.
• Describe the number of patient-reported outcomes up to 12 months — 12 months
  Describe the patient-reported outcomes up to 12 months; descriptive analysis will be performed on the data directly reported via the patients (patient questionnaires); information included are number of complications, re-hospitalizations, re-operations, disease recurrence, disease remission, new disease diagnosis and pain status including pain medication
• Characterize the treatment decision as reported by the treating physician — 30 days
  Characterize the treatment decision per data provided by the treating physician (within the study database) including the rationale given for the treatment decision (e.g., age of the patient or co-morbidity); number of treatment decisions, e.g., for surgical therapy (open surgery or minimal-invasive therapy), watchful waiting, or treatment with medication will be described; descriptive analysis will be performed

Trial sites (15)

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