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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
Sponsor:
Information provided by (Responsible Party):
Taejong Song, 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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

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



Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Kangbuk Samsung Hospital
Seoul, NJ, Korea, Republic of, 03181
Sponsors and Collaborators
Kangbuk Samsung Hospital
Investigators
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Principal Investigator: Taejong Song, MD,PhD Kangbuk Samsung Hospital
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Responsible Party: Taejong Song, Professor, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT02729272    
Other Study ID Numbers: 2016-04-012
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No