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

Completed

• Conditions: Benign Gynecologic Neoplasm
• Interventions: Procedure: Laparoscopy

• Registration Number: NCT05710601
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2021-03-01
• Status Verified: 2023-01
• Study Completion: 2023-01-01
• Study First Submitted: 2023-01-14
• Study First Submitted QC: 2023-02-01
• Last Update Submitted: 2023-02-01
• Study First Posted: 2023-02-02
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Bipolar forceps	Laparoscopy	Procedures performed using a 5 mm diameter, 35 cm classic rotating bipolar forceps
Tissue sealers	Laparoscopy	Procedures performed using a 5 mm diameter, 35 cm length curved branch radiofrequency tissue sealer connected to a dedicated electric generator

Primary Outcome Measures

Name	Time	Method
Vision of the surgical field	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	7 days	NRS 0-10 (considering 0 for "extremely easy" and 10 for "extremely difficult")

Secondary Outcome Measures

Name	Time	Method
Procedure time	Procedure
Overall procedural satisfaction	7 days	NRS 0-10 (considering 0 for "complicated or incomplete procedure" and 10 for "uncomplicated and satisfying intervention")

Trial Locations

Locations (1)

University of Campania Luigi Vanvitelli; 🇮🇹 Napoli, Italy