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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-12-01

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.

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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.

Conditions

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Activity, Motor Pain Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Women are randomized to either robotic single site or multi port lapsoscopic hystrectomy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Robotic single-site hysterectomy

Robotic single-site hysterectomy is performed in this arm

Group Type ACTIVE_COMPARATOR

Robotic single-site Hysterectomy

Intervention Type PROCEDURE

Robotic assisted Periumbilical single incision hysterectomy

Multiport Laparoscopy

Multiport Laparoscopic hysterectomy is performed in this other arm

Group Type ACTIVE_COMPARATOR

Laparoscopic hysterectomy

Intervention Type PROCEDURE

Multiport laparoscopic hysterectomy

Interventions

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Robotic single-site Hysterectomy

Robotic assisted Periumbilical single incision hysterectomy

Intervention Type PROCEDURE

Laparoscopic hysterectomy

Multiport laparoscopic hysterectomy

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No