Single Site Versus Multi Site Robotic Hysterectomy

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 multi site hysterectomy (R-MSH) in select patients regarding cosmesis and postoperative pain. A randomized trial is performed to compare R-SSH with R-MSH 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 November 2018 and compares robotic single site to multi site hysterectomy. Procedures are performed on two locations, Herning and Herlev Hospitals, by experienced surgeons. Patients are randomized to either R-SSH (No.=62) or R-MSH (No.=62). 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 and photo-evaluations. Postoperative pain and split times spent at the operation theatre will be registered as secondary outcome parameters. 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 R-MSH is performed using standard equipment and 4 trocars, 5 mm each. 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, the calculation was performed with an expected visual analog pain score of 0.86 ±0.2 and 62 in each group and suggested that 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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Single Site Versus Multi Site Robotic Hysterectomy

Conditions
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Rehabilitation, Pain, Postoperative, Wound Infection

Intervention / Treatment
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* Procedure: Robotic assisted 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 30 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
Maximum Age: 85 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 site hysterectomy
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 assisted hysterectomy<br>* Periumbilical single incision vs multiple abdominal incisions for hysterectomy<br>|
| Active Comparator: Robotic multi-site hysterectomy<br>Robotic multi-site hysterectomy is performed in this arm | Procedure: Robotic assisted hysterectomy<br>* Periumbilical single incision vs multiple abdominal incisions for hysterectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar appearance and satisfaction | Appearance and evaluation of scar by POSAS scale (see www.posas.org and reference below) which has a scale from 1-10, where 1 is minimum and 10 is maximum; on scar's pain, its itching, on difference from normal skin, on stiffness, on thickness, on irregularity and general satisfaction | Six months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scoring of abdominal pain | Visual analogue pain score with a minimum '0' and maximum '10' | Visual analogue pain score at first, second, third, fourth, fifth, and sixth month after operation | 

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