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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonic ESD | Experimental | Laparoscopic colpotomy by ultrasonic ESD (Harmonic Synergy Hook Blade; Ethicon Endo-Surgery) during total laparoscopic hysterectomy. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taejong Song, MD,PhD | Kangbuk Samsung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangbuk Samsung Hospital | Seoul | NJ | 03181 | South Korea |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| 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 | Device |
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| Ultrasonic ESD | Device |
|