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

NCT ID: NCT05710601

Last Updated: 2023-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2023-01-01

Brief Summary

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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

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Conditions

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Benign Gynecologic Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tissue sealers

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

Laparoscopy

Intervention Type PROCEDURE

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

Laparoscopy

Intervention Type PROCEDURE

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

Interventions

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Laparoscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Campania Luigi Vanvitelli

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Riemma

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Campania Luigi Vanvitelli

Napoli, , Italy

Site Status

Countries

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Italy

Other Identifiers

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712-15-11-19

Identifier Type: -

Identifier Source: org_study_id

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