Effects of Tissue Sealers on Minor Laparoscopic Procedures Between Obstetrics and Gynecology Residents

Study Overview
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Brief Summary
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The kind of equipment used during laparoscopic surgery may have an effect on how quickly resident surgeons improve their skills. The effects of these technologies on various general and specialized procedures have been the subject of numerous research, all of which have produced comparable results in terms of efficacy and safety. Although a minimally invasive laparoscopy represents the gold standard method in over 70% of procedures for uterine and adnexal benign diseases, there is a paucity of evidence regarding the potential advantages or disadvantages of such kinds of devices in gynecologic laparoscopy. Based on this, the purpose of this study was to determine whether using a hemostatic surgical device affects how quickly gynecology residents learn to execute simple laparoscopic procedures and how well they perform surgically.

Official Title
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Effects of Tissue Sealers on Minor Laparoscopic Procedures Between Obstetrics and Gynecology Residents

Conditions
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Benign Gynecologic Neoplasm

Intervention / Treatment
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* Procedure: Laparoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Senior gynecological surgeons At least 4 years of residency in gynecology Exclusion Criteria: Junior residents, fellows, consultants Operative procedures due to malignancy Women who were not suitable for or denied a laparoscopic approach Declined the procedure Did not sign a written informed consent form Suffering from a gynecologic malignant disease or severe systemic illnesses Laparotomic conversion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tissue sealers<br>Procedures performed using a 5 mm diameter, 35 cm length curved branch radiofrequency tissue sealer connected to a dedicated electric generator | Procedure: Laparoscopy<br>* Operative laparoscopies carried out according to the most recent national guidelines and following the good clinical practice of our operative unit.<br>|
| Bipolar forceps<br>Procedures performed using a 5 mm diameter, 35 cm classic rotating bipolar forceps | Procedure: Laparoscopy<br>* Operative laparoscopies carried out according to the most recent national guidelines and following the good clinical practice of our operative unit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vision of the surgical field | Numeric Rate Scale (NRS) 0-10 considering 0 for inadequate vision and 10 for optimal vision | 7 days | 
| Interpretation of the difficulty of the intervention | NRS 0-10 (considering 0 for extremely easy and 10 for extremely difficult) | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall procedural satisfaction | NRS 0-10 (considering 0 for complicated or incomplete procedure and 10 for uncomplicated and satisfying intervention) | 7 days | 
| Procedure time |  | Procedure |