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

Sponsor

University of Campania "Luigi Vanvitelli" (Other)

Overall Status

Completed

CT.gov ID

NCT05710601

Collaborator

(none)

Enrollment

Location

46.1

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Benign Gynecologic Neoplasm	Procedure: Laparoscopy

Study Design

Study Type:

Observational

Actual Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Mar 1, 2021

Actual Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 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	Procedure: Laparoscopy Operative laparoscopies carried out according to the most recent national guidelines and following the good clinical practice of our operative unit.

Arm

Intervention/Treatment

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

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

Procedure: Laparoscopy

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Campania Luigi Vanvitelli	Napoli		Italy	80138

Sponsors and Collaborators

University of Campania "Luigi Vanvitelli"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gaetano Riemma, Primary Investigator, University of Campania "Luigi Vanvitelli"

ClinicalTrials.gov Identifier:

NCT05710601

Other Study ID Numbers:

712-15-11-19

First Posted:

Feb 2, 2023

Last Update Posted:

Feb 2, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Genital Neoplasms, Female

Study Results

No Results Posted as of Feb 2, 2023