Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy

Kangbuk Samsung Hospital40 enrolled

Overview

The aim of this randomized trial was to compare the degree of surgical smoke obstructing vision and thermal damage caused by two different ESDs (ultrasonic versus monopolar ESD) in colpotomy during total laparoscopic hysterectomy.

According to previous studies performed in porcine and bovine tissues, ultrasonic energy based surgical devices (ESDs) created less surgical smoke, involved less visual obstruction, and produced less lateral thermal damage than monopolar ESDs. However, there was no study comparing ultrasonic ESD and monopolar ESD in laparoscopic colpotomy in terms of surgical smoke and lateral thermal damage. Therefore, the aim of this randomized trial was to compare the degree of surgical smoke obstructing vision and thermal damage caused by two different ESDs (ultrasonic versus monopolar ESD) in colpotomy during total laparoscopic hysterectomy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gynecologic Diseases

Interventions

Laparoscopic colpotomy by ultrasonic ESDPROCEDURE

In this intervention, laparoscopic colpotomy was performed by ultrasonic ESD (Harmonic Synergy Hook Blades; Ethicon Endo-Surgery, Cincinnati, OH, USA).

Laparoscopic colpotomy by monopolar ESDPROCEDURE

In this intervention, laparoscopic colpotomy was performed by monopolar ESD (hook electrode with 90 watts of unmodulated current; Karl Storz, Tuttlingen, Germany).

Monopolar ESDDEVICE

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * women with gynecologic diseases, such as uterine myoma, adenomyosis, and ovarian tumor; * women who were planning to undergo TLH; * women between 19 and 75 years of age. Exclusion Criteria: * women with any suggestion of malignant cervical or vaginal pathologies * women with uncontrolled medical comorbidities or psychiatric illness, which could affect follow-up and/or compliance * women who refused to participate or give consent to the procedures.

Locations (1)

Kangbuk Samsung Hospital

Seoul, NJ, South Korea

Outcomes

Primary Outcomes

Degree of surgical smoke obstructing vision

The degree of surgical smoke obstructing laparoscopic view was assessed by an independent, blinded, gynecologic surgeon who reviewed videotapes of each patient's laparoscopic colpotomy procedure using a 5-point Likert scale (1 = very clear; 2 = quite clear; 3 =somewhat smoky; 4 = quite smoky; and 5 = extremely smoky), and a higher score indicates a worse visuality

Time frame: Day of surgery

Degree of lateral thermal damage

Using a light microscope, the width of lateral thermal damage was measured from the point of instrument application to the margins of unchanged nearby tissue

Time frame: Day of surgery

Data from ClinicalTrials.gov

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