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

NCT05710601 | Completed

• 1 other identifier: 712-15-11-19
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Gynecologic Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Overall procedural satisfaction

  7 days

• Procedure time

  Procedure

Study Arms (2)

Tissue sealers

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

Procedure: Laparoscopy

Bipolar forceps

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

Procedure: Laparoscopy

Interventions

Laparoscopy PROCEDURE

Operative laparoscopies carried out according to the most recent national guidelines and following the good clinical practice of our operative unit.

Bipolar forceps; Tissue sealers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred from the outpatient gynecological clinics of our unit who, according to national and international treatment guidelines, were eligible for a planned laparoscopic surgery.

You may qualify if:

• Senior gynecological surgeons
• At least 4 years of residency in gynecology

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania Luigi Vanvitelli

Napoli, 80138, Italy

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: January 14, 2023
• First Posted: February 2, 2023
• Study Start: March 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: January 1, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)