Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy (ULMOST)

Kangbuk Samsung Hospital

Status: Completed

Conditions: Gynecologic Diseases

Treatments: Procedure: Laparoscopic colpotomy by monopolar ESD; Device: Monopolar ESD; Procedure: Laparoscopic colpotomy by ultrasonic ESD; Device: Ultrasonic ESD

Study type: Interventional

Funder types: Other

Identifiers

NCT02729272

2016-04-012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Ultrasonic ESD

Experimental group

Description:

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

Treatment:

Device: Ultrasonic ESD

Procedure: Laparoscopic colpotomy by ultrasonic ESD

Monopolar ESD

Active Comparator group

Description:

Laparoscopic colpotomy by monopolar ESD (hook electrode with 90 watts of unmodulated current; Karl Storz, Tuttlingen, Germany) during total laparoscopic hysterectomy.

Treatment:

Procedure: Laparoscopic colpotomy by monopolar ESD

Device: Monopolar ESD