Detecting the Most Efficient Residency Time for Laparoscopic Simulators

• Sponsor: Tepecik Training and Research Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05302622
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 8.4
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laparoscopy; Simulation Training	Other: There is no intervention planning	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: There is three group based on the surgical skills and ob/gyn residency years.There is three group based on the surgical skills and ob/gyn residency years.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Determination of the Most Efficacious Period for the Use of Laparoscopic Simulators in Obstetrics and Gynecology Specialty Training
• Actual Study Start Date: Oct 1, 2021
• Actual Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Jun 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Group 1 Have surgical experience both laparoscopy and laparotomy and senior resident	Other: There is no intervention planning; There is no intervention planning
Other: Group 2 Have surgical skills only laparotomic gynecologic procedures and in the middle of his/her residency	Other: There is no intervention planning; There is no intervention planning
Other: Group 3 Have no surgical experience on gynecologic procedures and newbie residents	Other: There is no intervention planning; There is no intervention planning

Outcome Measures

Primary Outcome Measures

1. Laparoscopic surgical procedures time [6 months]

Secondary Outcome Measures

1. Movement number for laparoscopic procedures [6 months]

2. Complication during laparoscopic surgery simulations [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 24 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Should be an ob/gyn resident

• Should except to participate study

Exclusion Criteria:

• Not to complete all simulations

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tepecik Education and Research Hospital	İzmir		Turkey

Sponsors and Collaborators

• Tepecik Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahkam Göksel Kanmaz, Associated Professor, Tepecik Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT05302622
• Other Study ID Numbers: 2021/10-48
• First Posted: Mar 31, 2022
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 31, 2022