Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy During Total Laparoscopic Hysterectomy in Terms of Surgical Smoke and Lateral Thermal Damage: a Randomized Controlled Trial (ULMOST Trial)

Conditions
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Gynecologic Diseases

Intervention / Treatment
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* Procedure: Laparoscopic colpotomy by ultrasonic ESD
* Procedure: Laparoscopic colpotomy by monopolar ESD
* Device: Monopolar ESD
* Device: Ultrasonic ESD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasonic ESD<br>Laparoscopic colpotomy by ultrasonic ESD (Harmonic Synergy Hook Blade; Ethicon Endo-Surgery) during total laparoscopic hysterectomy. | Procedure: Laparoscopic colpotomy by ultrasonic ESD<br>* In this intervention, laparoscopic colpotomy was performed by ultrasonic ESD (Harmonic Synergy Hook Blades; Ethicon Endo-Surgery, Cincinnati, OH, USA).<br>Device: Ultrasonic ESD<br> <br> |
| Active Comparator: Monopolar ESD<br>Laparoscopic colpotomy by monopolar ESD (hook electrode with 90 watts of unmodulated current; Karl Storz, Tuttlingen, Germany) during total laparoscopic hysterectomy. | Procedure: Laparoscopic colpotomy by monopolar ESD<br>* In this intervention, laparoscopic colpotomy was performed by monopolar ESD (hook electrode with 90 watts of unmodulated current; Karl Storz, Tuttlingen, Germany).<br>Device: Monopolar ESD<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Day of surgery |