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.
A prospective, non-interventional, multi-center, post market clinical study.
Study Type
OBSERVATIONAL
Enrollment
1,250
Robotic-assisted surgery (da Vinci)
Non-da Vinci Surgery
Albertinen Krankenhaus Hamburg
Hamburg, Free and Hanseatic City of Hamburg, Germany
ACTIVE_NOT_RECRUITINGSt. Josefs-Hospital Wiesbaden
Wiesbaden, Hesse, Germany
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.
Time frame: 30 days
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
Time frame: 12 months
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
Time frame: 30 days
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)
Time frame: 30 days
Investigate the impact of patient characteristics on clinical outcome
Descriptive analysis of patient characteristics such as age on clinical outcome (e.g., re-operation)
Time frame: 30 days
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Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie
Berlin, Germany
ACTIVE_NOT_RECRUITINGAugusta-Kranken-Anstalt Bochum
Bochum, Germany
ACTIVE_NOT_RECRUITINGSana Kliniken Coburg
Coburg, Germany
ACTIVE_NOT_RECRUITINGSt. Elisabeth-Krankenhaus Köln-Hohenlind
Cologne, Germany
TERMINATEDUniversitätsklinikum Essen
Essen, Germany
ACTIVE_NOT_RECRUITINGAgaplesion Markus Krankenhaus Frankfurt am Main
Frankfurt am Main, Germany
ACTIVE_NOT_RECRUITINGUniversitätsklinikum Freiburg - Klinik für Frauenheilkunde
Freiburg im Breisgau, Germany
RECRUITINGUniversitätsmedizin Greifswald
Greifswald, Germany
RECRUITING...and 5 more locations
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)
Time frame: 30 days
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)
Time frame: 12 months
Describe the number of Intuitive instruments used per procedure and patient characteristics
Describe the number of Intuitive instruments used per procedure and patient characteristics; descriptive analysis will be performed on the number of instruments used per specific procedure and patient
Time frame: 30 days
Describe the number of disease recurrence and re-operation at final patient follow-up
Describe the number disease recurrence and re-operation at final patient follow-up; descriptive analysis will be performed
Time frame: 12 months
Describe the number of conversion per procedure and patient characteristics
Describe the number conversion per procedure and patient characteristics; descriptive analysis will be performed
Time frame: 30 days
Describe the impact of surgeon experience on surgical times (duration of surgery per treating surgeon)
Describe the impact of surgeon experience on surgical times, descriptive analysis will be performed on the surgical times (duration of surgery) per treating surgeon
Time frame: 30 days
Describe the impact of surgeon experience on clinical outcome (number of clinical outcomes per treating surgeon)
Describe the impact of surgeon experience on clinical outcome; descriptive analysis will be performed, e.g., on number of re-operation or re-hospitalization per treating surgeon
Time frame: 30 days
Describe the impact of surgeon experience on complications (number of events per surgeon)
Describe the impact of surgeon experience on complications; descriptive analysis will be performed on number of adverse events per treating surgeon
Time frame: 30 days