Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access

Study Overview
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Brief Summary
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robotic single site surgery (R-SSH) is a novel technique, which may be superior to conventional multiport hysterectomy in select patients regarding cosmesis and postoperative pain. We, perform a randomized trial to compare R-SSH with multiport laparoscopic hysterectomy with regard to the postoperative rehabilitation, cosmesis, the operational cost, and the perioperative morbidity.

Detailed Description
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The study is scheduled to start February 2018 and compares robotic single-site hysterectomy to conventional multiport hysterectomy. Procedures are performed by an experienced two-surgeon team. Patients are randomized to either conventional multiport hysterectomy (N=62) or R-SSH (N=62). Eligibility criteria are the same as for study 1. Patient's satisfaction with body image and cosmesis is assessed at different time points pre- and postoperatively by means of validated cosmesis scales and Body Image Questionnaire. Postoperative pain and analgesia use will be registered as well as secondary outcome parameters as described above. A follow-up at 1, 3 and 6 month include evaluation of the scar and registration of port-site hernias and vaginal dehiscence or other complications. Interviews and diaries will include time of return to home and work, daily activities including sexuality The R-SSH is performed using da Vinci, Xi robotic system. One single port, diameter 2 cm is applied. Applying an additional assistant port is defined conversion of procedure The laparoscopy is performed using our standard equipment and 4 trocars, 5 mm each. Socio-economical consequences of R-SSH versus conventional laparoscopic hysterectomy Study details in preparation Sample size calculation was based a previous study on fast track hysterectomy, which showed a difference in return to work of 4 days. 62 women in each group is needed with standard deviation ±8 and a power of 80%. To include those not working, we calculated that with an expected visual analog pain score of 0.86 ±0.2 and 62 in each group the sample was sufficient to detect of difference of 0.1 in visual analog pain score with a power of 80%. All calculation are based on two-sided testing with alpha of 0.05.

Official Title
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Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access

Conditions
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Activity, Motor, Pain, Wound

Intervention / Treatment
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* Procedure: Robotic single-site Hysterectomy
* Procedure: Laparoscopic hysterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hysterectomy on benign indication, American Society of Anesthetists group 1 or 2, BMI less than 35 kg/m2 uterine size less than 300 g estimated by ultrasound, using Ferraris formula. Exclusion Criteria: adhesions prior extensive abdominal surgery prior midline incision, cutis laxa of abdomen surgery endometriosis more than 1 cesarean section malignant disease

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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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
Interventional Model Description: Women are randomized to either robotic single site or multi port lapsoscopic hystrectomy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic single-site hysterectomy<br>Robotic single-site hysterectomy is performed in this arm | Procedure: Robotic single-site Hysterectomy<br>* Robotic assisted Periumbilical single incision hysterectomy<br>|
| Active Comparator: Multiport Laparoscopy<br>Multiport Laparoscopic hysterectomy is performed in this other arm | Procedure: Laparoscopic hysterectomy<br>* Multiport laparoscopic hysterectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return-to-work | Time from operation to return work | up to six months after operation or until work is resumed, whichever came first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured by subjective score | Visual analogue pain score with a minimum of '0' up to '10' on a 10 cm continious scale | Visual analogue pain score first, second, third, fourth, fifth, and six months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Return-to-work, Visual analogue pain score, Cosmesis