Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy

Not Applicable

Completed

• Conditions: Gynecologic Diseases
• Interventions: Procedure: Laparoscopic colpotomy by ultrasonic ESD; Procedure: Laparoscopic colpotomy by monopolar ESD; Device: Ultrasonic ESD; Device: Monopolar ESD

• Registration Number: NCT02729272
• Lead Sponsor: Kangbuk Samsung Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-03-29
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-06
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasonic ESD	Ultrasonic ESD	Laparoscopic colpotomy by ultrasonic ESD (Harmonic Synergy Hook Blade; Ethicon Endo-Surgery) during total laparoscopic hysterectomy.
Monopolar ESD	Monopolar ESD	Laparoscopic colpotomy by monopolar ESD (hook electrode with 90 watts of unmodulated current; Karl Storz, Tuttlingen, Germany) during total laparoscopic hysterectomy.
Ultrasonic ESD	Laparoscopic colpotomy by ultrasonic ESD	Laparoscopic colpotomy by ultrasonic ESD (Harmonic Synergy Hook Blade; Ethicon Endo-Surgery) during total laparoscopic hysterectomy.
Monopolar ESD	Laparoscopic colpotomy by monopolar ESD	Laparoscopic colpotomy by monopolar ESD (hook electrode with 90 watts of unmodulated current; Karl Storz, Tuttlingen, Germany) during total laparoscopic hysterectomy.

Primary Outcome Measures

Name	Time	Method
Degree of surgical smoke obstructing vision	Day of surgery	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
Degree of lateral thermal damage	Day of surgery	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

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, NJ, Korea, Republic of