Clinical Trial Comparing Conventional and Robot-assisted(Da Vinci®)Laparoscopic Interventions for Hysterectomy

Study Overview
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Brief Summary
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The aim of this study is to compare conventional with robot-assisted (Da Vinci®) laparoscopic hysterectomy regarding operating time peri-operative outcome and costs.

Detailed Description
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During the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynaecological surgery are very limited. Several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. For better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic hysterectomy techniques. This randomized clinical trail intends to compare conventional with robot-assisted(da Vinci®-System) laparoscopic hysterectomy regarding specific parameters. The focus of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalisation and costs.

Official Title
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Laparoscopic Hysterectomy: a Clinical Randomized Trial Comparing Conventional and Robot-assisted(Da Vinci®)Techniques

Conditions
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Laparoscopic Technique no Switch to Open, Duration of Surgery, Intraoperative Complications, Postoperative Complications

Intervention / Treatment
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* Procedure: Conventional Laparoscopic Hysterectomy
* Procedure: Robot-assisted (Da Vinci®) laparoscopic hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for laparoscopic hysterectomy Patients BMI < 40 Signed consent Exclusion Criteria: Estimated uterus weight >400 g No combination with other procedures No underlying malignant condition

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: 1<br>Randomized group of patients receiving conventional laparoscopic hysterectomy | Procedure: Conventional Laparoscopic Hysterectomy<br>* Removal of uterus via standard laparoscopic techniques<br>* Other names: - Minimal invasive removal of uterus;|
| Active Comparator: 2<br>Randomized group of patients receiving robot-assisted laparoscopic hysterectomy | Procedure: Robot-assisted (Da Vinci®) laparoscopic hysterectomy<br>* Removal of uterus by robot-assisted laparoscopic technique<br>* Other names: - Robot-assisted minimal invasive hysterectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Surgery | •Mean Time to complete surgery from cut to suture | after surgey | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  | up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Hysterectomy, Robot-assisted Laparoscopic Hysterectomy, Robot-assisted Surgery