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

February 1, 2023 updated by: Gaetano Riemma, University of Campania "Luigi Vanvitelli"

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy, 80138
        • University of Campania Luigi Vanvitelli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
7 days
Interpretation of the difficulty of the intervention
Time Frame: 7 days
NRS 0-10 (considering 0 for "extremely easy" and 10 for "extremely difficult")
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall procedural satisfaction
Time Frame: 7 days
NRS 0-10 (considering 0 for "complicated or incomplete procedure" and 10 for "uncomplicated and satisfying intervention")
7 days
Procedure time
Time Frame: Procedure
Procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campania "Luigi Vanvitelli"

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2019

Primary Completion (ACTUAL)

March 1, 2021

Study Completion (ACTUAL)

January 1, 2023

Study Registration Dates

First Submitted

January 14, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (ACTUAL)

February 2, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 712-15-11-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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