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

Benign Gynecologic Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05710601
• Other study ID #: 712-15-11-19
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: January 2023
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 1, 2023
• Est. primary completion date: March 1, 2021
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Gynecologic Neoplasm
• Genital Neoplasms, Female

Intervention

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

Locations

Country	Name	City	State
Italy	University of Campania Luigi Vanvitelli	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vision of the surgical field	Numeric Rate Scale (NRS) 0-10 considering 0 for "inadequate vision" and 10 for "optimal vision"	7 days
Primary	Interpretation of the difficulty of the intervention	NRS 0-10 (considering 0 for "extremely easy" and 10 for "extremely difficult")	7 days
Secondary	Overall procedural satisfaction	NRS 0-10 (considering 0 for "complicated or incomplete procedure" and 10 for "uncomplicated and satisfying intervention")	7 days
Secondary	Procedure time		Procedure