Ultrasonic Versus Monopolar Energy-based Surgical Device in Colpotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-04-30

Brief Summary

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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.

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Detailed Description

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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

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Gynecologic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ultrasonic ESD

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

Group Type EXPERIMENTAL

Laparoscopic colpotomy by ultrasonic ESD

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No