NCT05302622

Brief Summary

Laparoscopic surgeries is one of the most common surgery in gynecologic procedures. Nowadays there are many laparoscopic simulators for training residents. In this study it is aimed to determine the most efficient residency year for laparoscopic simulators. This study planned as a prospective study. There will be three group which include ob/gyn residents. The residents will choose based on their residency year and surgery skills. 1. The residents who makes surgeries both laparoscopic and laparotomic, 2. The residents who makes surgeries only laparotomic, 3. The residents who won't any gynecologic surgery The data of surgery time, complications and movement numbers will take from the simulator. Tubal ligation and salpingooferectomy choose for the surgery examples. The simulation results of participants will compare and try to find the best improvement term for residency.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

March 21, 2022

Last Update Submit

March 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Laparoscopic surgical procedures time

    6 months

Secondary Outcomes (2)

  • Movement number for laparoscopic procedures

    6 months

  • Complication during laparoscopic surgery simulations

    6 months

Study Arms (3)

Group 1

OTHER

Have surgical experience both laparoscopy and laparotomy and senior resident

Other: There is no intervention planning

Group 2

OTHER

Have surgical skills only laparotomic gynecologic procedures and in the middle of his/her residency

Other: There is no intervention planning

Group 3

OTHER

Have no surgical experience on gynecologic procedures and newbie residents

Other: There is no intervention planning

Interventions

There is no intervention planning

Group 1Group 2Group 3

Eligibility Criteria

Age24 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Should be an ob/gyn resident
  • Should except to participate study

You may not qualify if:

  • Not to complete all simulations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tepecik Education and Research Hospital

Izmir, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: There is three group based on the surgical skills and ob/gyn residency years.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

March 21, 2022

First Posted

March 31, 2022

Study Start

October 1, 2021

Primary Completion

January 1, 2022

Study Completion

June 15, 2022

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations