Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy

NCT02729272 | Completed

• 1 other identifier: 2016-04-012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Diseases

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Ultrasonic ESD

EXPERIMENTAL

Laparoscopic colpotomy by ultrasonic ESD (Harmonic Synergy Hook Blade; Ethicon Endo-Surgery) during total laparoscopic hysterectomy.

Procedure: Laparoscopic colpotomy by ultrasonic ESD; Device: Ultrasonic ESD

Monopolar ESD

ACTIVE COMPARATOR

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; Device: Monopolar ESD

Interventions

Laparoscopic colpotomy by ultrasonic ESD PROCEDURE

In this intervention, laparoscopic colpotomy was performed by ultrasonic ESD (Harmonic Synergy Hook Blades; Ethicon Endo-Surgery, Cincinnati, OH, USA).

Ultrasonic ESD

Laparoscopic colpotomy by monopolar ESD PROCEDURE

In this intervention, laparoscopic colpotomy was performed by monopolar ESD (hook electrode with 90 watts of unmodulated current; Karl Storz, Tuttlingen, Germany).

Monopolar ESD

Monopolar ESD DEVICE

Monopolar ESD

Ultrasonic ESD DEVICE

Ultrasonic ESD

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, NJ, 03181, South Korea

Location

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Taejong Song, MD,PhD

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 6, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)