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This is a prospective, randomized, single-center, observational clinical trial at the Department of Women's Health of the University Clinic Tübingen. Four hundred patients affected by uterine diseases that undergo treatment with robotic assisted laparoscopic procedures using the Da Vinci Robotic Surgical System (200 patients) or conventional laparoscopic surgery (200 patients) will be recruited. In addition retrospective data of 200 patients that underwent conventional laparoscopic surgery in the past will be documented. At the end of patient recruitment, surgical procedure times, the technical limits encountered, estimated blood loss, intra- and post-operative complications and the percentage of conversions from the robotic assisted treatment /conventional laparoscopic surgery to multiple access and/or to a laparotomic (open) approach will be documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Da Vinci Robotic Surgical System |
| ||
| conventional laparoscopic surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic surgery | Procedure | patients affected by uterine diseases that undergo treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| operative time | (minutes from first incision to skin closure) | 60 minutes |
| time under narcosis | 60 minutes | |
| console time | 60 minutes | |
| estimated blood loss (milliliters) | using the following formula: ((Hemoglobin concentration preoperative (g/l)) - (Hemoglobin 1st day postoperative (g/l)))/((Hemoglobin preoperative (g/l)) - (Hemoglobin 1st day postoperative (g/l)))/2) × 1000 | 60 minutes |
| conversion to other surgical procedures | 60 minutes | |
| time to discharge | 60 minutes | |
| intraoperative complications | occurring during the surgical procedure | 60 minutes |
| perioperative complications | occurring less than 24h after the surgical procedure, according to the Clavien-Dindo classification of surgical complications | 24 hours |
| postoperative complications | occurring more than 24h after the surgical procedure up to 6 months after surgical procedure, according to the Clavien-Dindo classification of surgical complications |
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Inclusion Criteria:
Exclusion Criteria:
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primary care clinic
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tuebingen, Department of Women's Health | Tübingen | 72076 | Germany |
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| 6 months |
| German version of the Short Form-36health survey questionnaire Medical Outcomes Trust | Medical Outcomes Trust: SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. | 3 and 6 months |
| German version of the female sexual function index (FSFI) questionnaire | female sexual function index: a multidimensional self-report instrument for the assessment of female sexual function | 3 and 6 months |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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