Minimally Invasive Benign Hysterectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Benign Hysterectomy; a Randomized Controlled Trial Comparing Robotic Hysterectomy With Vaginal Hysterectomy and Traditional Laparoscopic Hysterectomy

Conditions
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Menorrhagia, Metrorrhagia, Uterine Fibroids, Cervical Dysplasia

Intervention / Treatment
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* Device: Robotic hysterectomy
* Procedure: Vaginal or laparoscopic hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer size of uterus and vagina allows for retrieval by the vaginal route maximum uterine size equivalent to 16 weeks of pregnancy informed consent Exclusion Criteria: malignant disease known extensive intra-abdominal adhesions anaesthesiological contraindications to laparoscopic surgery women with pacemaker or other implants where electrosurgery is to be avoided immunoincompetent women simultaneous need for prolapse surgery women with known defects of the hemostasis allergies towards metronidazole and doxycycline inability to understand patient information

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic hysterectomy<br>Minimally invasive hysterectomy by robotic surgery | Procedure: Vaginal or laparoscopic hysterectomy<br>* Benign hysterectomy performed by traditional minimal invasive procedures.<br>|
| Active Comparator: Vaginal or laparoscopic hysterectomy<br>Minimal invasive hysterectomy by vaginal or traditional laparoscopic surgery. | Device: Robotic hysterectomy<br>* Minimally invasive hysterectomy for benign disorders. Comparing robotic hysterectomy with vaginal hysterectomy and traditional laparoscopic hysterectomy<br>* Other names: da Vinci Surgical system, Intuitive Surgical Inc, CA, USA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |