Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy

Gynecologic Diseases Clinical Trial

— ULMOST  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02729272
• Other study ID #: 2016-04-012
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Diseases

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