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Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy

Not Applicable
Completed
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
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
Primary Outcome Measures
NameTimeMethod
Degree of surgical smoke obstructing visionDay 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 damageDay 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
NameTimeMethod

Trial Locations

Locations (1)

Kangbuk Samsung Hospital

🇰🇷

Seoul, NJ, Korea, Republic of

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

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