Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access
- Conditions
- WoundActivity, MotorPain
- Interventions
- Procedure: Robotic single-site HysterectomyProcedure: Laparoscopic hysterectomy
- Registration Number
- NCT03373513
- Lead Sponsor
- Herning Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- 124
- 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.
- adhesions
- prior extensive abdominal surgery
- prior midline incision,
- cutis laxa of abdomen surgery
- endometriosis
- more than 1 cesarean section
- malignant disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robotic single-site hysterectomy Robotic single-site Hysterectomy Robotic single-site hysterectomy is performed in this arm Multiport Laparoscopy Laparoscopic hysterectomy Multiport Laparoscopic hysterectomy is performed in this other arm
- Primary Outcome Measures
Name Time Method Return-to-work up to six months after operation or until work is resumed, whichever came first Time from operation to return work
- Secondary Outcome Measures
Name Time Method Pain measured by subjective score Visual analogue pain score first, second, third, fourth, fifth, and six months after operation Visual analogue pain score with a minimum of '0' up to '10' on a 10 cm continious scale
Trial Locations
- Locations (1)
Gynecology Dept. Herning Hospital
🇩🇰Herning, Denmark