Gynecologic Diseases
Conditions
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.
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.
Interventions
PROCEDURELaparoscopic colpotomy by ultrasonic ESD
In this intervention, laparoscopic colpotomy was performed by ultrasonic ESD (Harmonic Synergy Hook Blades; Ethicon Endo-Surgery, Cincinnati, OH, USA).
PROCEDURELaparoscopic 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).
DEVICEMonopolar ESD
DEVICEUltrasonic ESD
Sponsors
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of surgical smoke obstructing vision | Day of surgery | 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 |
| Degree of lateral thermal damage | Day of surgery | 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 |
Countries
South Korea
Outcome results
None listed