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OpenTrials
Completed

NCT Number: NCT05710601

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

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.

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Key information

Conditions

Benign Gynecologic Neoplasm

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Campania Luigi Vanvitelli

Naples, 80138, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopy

Procedure

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

Primary outcomes

  1. 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"

  2. Interpretation of the difficulty of the intervention

    Time frame: 7 days

    NRS 0-10 (considering 0 for "extremely easy" and 10 for "extremely difficult")

Secondary outcomes

  1. Overall procedural satisfaction

    Time frame: 7 days

    NRS 0-10 (considering 0 for "complicated or incomplete procedure" and 10 for "uncomplicated and satisfying intervention")

  2. Procedure time

    Time frame: Procedure

Sponsors and collaborators

Lead sponsor

University of Campania Luigi Vanvitelli

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Feb 2, 2023
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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