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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02729272
Other study ID # 2016-04-012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date April 2017

Study information

Verified date April 2019
Source Kangbuk Samsung Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 40
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Female
Age group 19 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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).
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

Ultrasonic ESD


Locations

Country Name City State
Korea, Republic of Kangbuk Samsung Hospital Seoul NJ

Sponsors (1)

Lead Sponsor Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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