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.
Woman with 18 years of age or older
Patient is willing to participate and to comply with the study procedures as demonstrated by signing the informed consent
Patient is a candidate for a gynecological procedure to be performed with the Intuitive Surgical System
Life expectancy of less than 1 year
Pregnancy, or positive pregnancy test for women prior to menopause or breastfeeding women
Current participation in a clinical study, if not pre-approved by Intuitive
Individuals who are unable to fully understand all aspects of the study that are relevant to the decision to participate (mentally or verbally), or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliation
Patients with gynecological disease that may be treated by surgical intervention.
Cohort
Prospective
Robotic-assisted surgery (da Vinci)
DeviceRobotic-assisted surgery (da Vinci)
Non-da Vinci Surgery
DeviceNon-da Vinci Surgery
Number of complications related to the surgery up to 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
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
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
Investigate the impact of patient characteristics on surgery
Descriptive analysis of patient characteristics such as age on surgery (e.g., duration of surgery, instrument usage)
Investigate the impact of patient characteristics on clinical outcome
Descriptive analysis of patient characteristics such as age on clinical outcome (e.g., re-operation)
Investigate the impact of patient characteristics on complications
Descriptive analysis of patient characteristics such as age on complication (number of complications reported during and after the surgery)
Describe the impact from surgery to the patient's quality of life and function
Describe the impact from surgery to the patient's quality of life and function by comparing the baseline quality of life and functional status with the post-operative status (post-operative day 1-3, 30 days, 90 days, 6 months and 12 months)
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