Effects of Tissue Sealers on Minor Laparoscopic Procedures Between Obstetrics and Gynecology Residents
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Vision of the surgical field
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Vision of the surgical field
Time Frame: 7 days
Numeric Rate Scale (NRS) 0-10 considering 0 for "inadequate vision" and 10 for "optimal vision"
Interpretation of the difficulty of the intervention
Time Frame: 7 days
NRS 0-10 (considering 0 for "extremely easy" and 10 for "extremely difficult")
Secondary Outcomes
- Overall procedural satisfaction(7 days)
- Procedure time(Procedure)
Investigators
Gaetano Riemma
Primary Investigator
University of Campania "Luigi Vanvitelli"