Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy (ULMOST)

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)

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 Overview

• Status: Completed
• Conditions: Gynecologic Diseases
• Intervention / Treatment: Procedure: Laparoscopic colpotomy by ultrasonic ESD; Device: Ultrasonic ESD; Procedure: Laparoscopic colpotomy by monopolar ESD; Device: Monopolar ESD

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • NJ
    • Seoul, NJ, Korea, Republic of, 03181
      • Kangbuk Samsung Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital
• Investigators: Principal Investigator: Taejong Song, MD,PhD, Kangbuk Samsung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: March 29, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 2016-04-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO