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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05710601
Enrollment
80
Registered
2023-02-02
Start date
2019-03-01
Completion date
2023-01-01
Last updated
2023-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Gynecologic Neoplasm

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.

Interventions

PROCEDURELaparoscopy

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

Sponsors

University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Vision of the surgical field7 daysNumeric Rate Scale (NRS) 0-10 considering 0 for inadequate vision and 10 for optimal vision
Interpretation of the difficulty of the intervention7 daysNRS 0-10 (considering 0 for extremely easy and 10 for extremely difficult)

Secondary

MeasureTime frameDescription
Overall procedural satisfaction7 daysNRS 0-10 (considering 0 for complicated or incomplete procedure and 10 for uncomplicated and satisfying intervention)
Procedure timeProcedure

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026