Effects of Tissue Sealers on Minor Laparoscopic Procedures Between Obstetrics and Gynecology Residents
NCT ID: NCT05710601
Last Updated: 2023-02-02
Study Results
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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COMPLETED
80 participants
OBSERVATIONAL
2019-03-01
2023-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tissue sealers
Procedures performed using a 5 mm diameter, 35 cm length curved branch radiofrequency tissue sealer connected to a dedicated electric generator
Laparoscopy
Operative laparoscopies carried out according to the most recent national guidelines and following the good clinical practice of our operative unit.
Bipolar forceps
Procedures performed using a 5 mm diameter, 35 cm classic rotating bipolar forceps
Laparoscopy
Operative laparoscopies carried out according to the most recent national guidelines and following the good clinical practice of our operative unit.
Interventions
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Laparoscopy
Operative laparoscopies carried out according to the most recent national guidelines and following the good clinical practice of our operative unit.
Eligibility Criteria
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Inclusion Criteria
* At least 4 years of residency in gynecology
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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University of Campania Luigi Vanvitelli
OTHER
Responsible Party
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Gaetano Riemma
Primary Investigator
Locations
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University of Campania Luigi Vanvitelli
Napoli, , Italy
Countries
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Other Identifiers
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712-15-11-19
Identifier Type: -
Identifier Source: org_study_id
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