Single Site Versus Multi Site Robotic Hysterectomy

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WITHDRAWN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

2024-10-15

Study Completion Date

2026-11-01

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.

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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.

Conditions

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Rehabilitation Pain, Postoperative Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Women are randomized to either robotic single site or multi site hysterectomy

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 assisted hysterectomy

Intervention Type PROCEDURE

Periumbilical single incision vs multiple abdominal incisions for hysterectomy

Robotic multi-site hysterectomy

Robotic multi-site hysterectomy is performed in this arm

Group Type ACTIVE_COMPARATOR

Robotic assisted hysterectomy

Intervention Type PROCEDURE

Periumbilical single incision vs multiple abdominal incisions for hysterectomy

Interventions

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Robotic assisted hysterectomy

Periumbilical single incision vs multiple abdominal incisions for 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 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No