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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| da Vinci Patients | Consecutive enrollment of patients with indications of interest and having a da Vinci robotic-assisted surgery |
| |
| Epidemiological Data Audit | Extended data collection on patients with indications of interest, eligible for a robotic-assisted surgery, but treatment choice was not a da Vinci surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted surgery (da Vinci) | Device | Robotic-assisted surgery (da Vinci) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30 days |
| Investigate the impact of patient characteristics on clinical outcome |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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Patients with gynecological disease that may be treated by surgical intervention.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petra Kremer | Contact | +49 151 62679136 | petra.kremer@intusurg.com | |
| Peter Appenrodt | Contact | +49 173 2043740 | peter.appenrodt@intusurg.com |
| Name | Affiliation | Role |
|---|---|---|
| Ingolf Juhasz-Böss, Prof. Dr. | Universitätsklinikum Freiburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albertinen Krankenhaus Hamburg | Recruiting | Hamburg | Free and Hanseatic City of Hamburg | 22457 | Germany |
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| Non-da Vinci Surgery |
| Device |
Non-da Vinci Surgery |
|
Descriptive analysis of patient characteristics such as age on clinical outcome (e.g., re-operation) |
| 30 days |
| 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 30 days |
| St. Josefs-Hospital Wiesbaden | Recruiting | Wiesbaden | Hesse | 65189 | Germany |
|
| Charité - Universitätsmedizin Berlin - Klinik für Gynäkologie | Recruiting | Berlin | 13353 | Germany |
|
| Augusta-Kranken-Anstalt Bochum | Recruiting | Bochum | 44791 | Germany |
|
| Sana Kliniken Coburg | Recruiting | Coburg | 96450 | Germany |
|
| St. Elisabeth-Krankenhaus Köln-Hohenlind | Terminated | Cologne | 50935 | Germany |
| Universitätsklinikum Essen | Recruiting | Essen | 45147 | Germany |
|
| Agaplesion Markus Krankenhaus Frankfurt am Main | Recruiting | Frankfurt am Main | 60431 | Germany |
|
| Universitätsklinikum Freiburg - Klinik für Frauenheilkunde | Recruiting | Freiburg im Breisgau | 79106 | Germany |
|
| Universitätsmedizin Greifswald | Recruiting | Greifswald | 17475 | Germany |
|
| St. Ansgar Krankenhaus Höxter | Recruiting | Höxter | 37671 | Germany |
|
| Universitätsklinikum Kiel | Recruiting | Kiel | 24105 | Germany |
|
| Klinikum Nürnberg Nord / Klinik für Frauenheilkunde | Recruiting | Nuremberg | 90419 | Germany |
|
| Helios Kliniken Schwerin | Recruiting | Schwerin | 19055 | Germany |
|
| Universitätsklinikum Tübingen - Frauenklinik | Active, not recruiting | Tübingen | 72076 | Germany |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
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