Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy
- Conditions
- Gynecologic Diseases
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- 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.
- 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
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kangbuk Samsung Hospital
🇰🇷Seoul, NJ, Korea, Republic of
Kangbuk Samsung Hospital🇰🇷Seoul, NJ, Korea, Republic of