NCT02729272

Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Kangbuk Samsung Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynecologic Diseases

Interventions

Type	Name	Description
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).
PROCEDURE	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
DEVICE	Ultrasonic ESD

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-04-01
• Completion: 2017-04-01
• First posted: 2016-04-06
• Last updated: 2019-04-03

Locations

1 site across 1 country: South Korea