Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy (ULMOST)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02729272|
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : April 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Diseases||Procedure: Laparoscopic colpotomy by ultrasonic ESD Procedure: Laparoscopic colpotomy by monopolar ESD Device: Monopolar ESD Device: Ultrasonic ESD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||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)|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||April 2017|
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
- Degree of surgical smoke obstructing vision [ Time Frame: 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 [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729272
|Korea, Republic of|
|Kangbuk Samsung Hospital|
|Seoul, NJ, Korea, Republic of, 03181|
|Principal Investigator:||Taejong Song, MD,PhD||Kangbuk Samsung Hospital|