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

Herning Hospital

Status: Withdrawn

Conditions: Wound; Activity, Motor; Pain

Treatments: Procedure: Laparoscopic hysterectomy; Procedure: Robotic single-site Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03373513

R-SSH

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Robotic single-site hysterectomy

Active Comparator group

Description:

Robotic single-site hysterectomy is performed in this arm

Treatment:

Procedure: Robotic single-site Hysterectomy

Multiport Laparoscopy

Active Comparator group

Description:

Multiport Laparoscopic hysterectomy is performed in this other arm

Treatment:

Procedure: Laparoscopic hysterectomy