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A randomised controlled trial comparing hysterectomy by minimally invasive surgical methods; robotic hysterectomy versus vaginal hysterectomy or traditional laparoscopic hysterectomy; outcome and cost analyses.
Laparoscopic surgery is advantageous compared to open surgery in terms of patient morbidity, shorter hospitalization and a more rapid return to daily activities. Robot-assisted laparoscopic surgery have facilitated a higher proportion of minimally invasive surgery first and foremost within gynecologic oncology.It is not clear whether or not this is true for less advanced surgery where a vaginal approach or a traditional laparoscopic approach is possible.
Robot-assisted surgery is associated with additional cost due to investment and more expensive surgical equipment. The study is performed to investigate whether or not performing hysterectomy for benign conditions with robotic surgery will be advantageous in terms of shorter operating time, less complications, less conversions to open surgery, and shorter hospital stay in comparison to other minimally invasive procedures such as vaginal hysterectomy and traditional laparoscopic hysterectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic hysterectomy | Active Comparator | Minimally invasive hysterectomy by robotic surgery |
|
| Vaginal or laparoscopic hysterectomy | Active Comparator | Minimal invasive hysterectomy by vaginal or traditional laparoscopic surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic hysterectomy | Device | Minimally invasive hysterectomy for benign disorders. Comparing robotic hysterectomy with vaginal hysterectomy and traditional laparoscopic hysterectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of surgery | The cost of surgery includes the actual surgery (anaesthesia, OR-nurse, circulating nurse, doctors and use of the OR) as well as the length of the inpatient stay. The cost for conversions to open surgery, reoperations, readmissions, and any additional cost associated with additional procedures or medical interventions such as radiological examinations and blood transfusions. Based on the estimated cost of surgical material, use of the operating room and cost of anaesthesia each benign hysterectomy performed with robotic surgery would need to be 50 minutes shorter than other minimal invasive procedures to compensate for the additional cost. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient outcome | The number of patients in whom an intraoperative or postoperative complication occurs as well as the seriousness of the complication which occurs and what this entails for the patient in question. This includes conversions to open surgery as well as the need for reoperation and readmission. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Social cost | The length of postoperative sick leave and reasons for extending sick leave and cost thereof. | 4 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Persson, MD, PhD | Department of Obstetrics and Gynecology, Skane University Hospital, Lund | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, Skane University Hospital | Lund | 221 85 | Sweden |
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| ID | Term |
|---|---|
| D008595 | Menorrhagia |
| D008796 | Metrorrhagia |
| D007889 | Leiomyoma |
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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|
| Vaginal or laparoscopic hysterectomy | Procedure | Benign hysterectomy performed by traditional minimal invasive procedures. |
|
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D011230 | Precancerous Conditions |
| D002577 | Uterine Cervical Diseases |