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

University of Campania "Luigi Vanvitelli"

Status: Completed

Conditions: Benign Gynecologic Neoplasm

Treatments: Procedure: Laparoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT05710601

712-15-11-19

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

Tissue sealers

Description:

Procedures performed using a 5 mm diameter, 35 cm length curved branch radiofrequency tissue sealer connected to a dedicated electric generator

Treatment:

Procedure: Laparoscopy

Bipolar forceps

Description:

Procedures performed using a 5 mm diameter, 35 cm classic rotating bipolar forceps

Treatment:

Procedure: Laparoscopy