Preoperative Warm-up in Gynecologic Surgery

Gynecologic Disorders Clinical Trial

Official title:

Preoperative Warm-up in Gynecologic Surgery Using a Virtual Reality Simulator.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01712607
• Other study ID #: Warm-Up-1.0
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2012
• Last updated: June 14, 2015
• Start date: October 2012
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background and Objectives: All modern surgical procedures require a high level of cognitive and psychomotor skills achieved using different training methods, but could be influenced by fatigue and other psychological factors. We evaluate the effect of warm-up exercises on operative laparoscopic performances in gynecologic laparoscopic procedures.

Methods: The surgical team operates on a consecutive series of 20 patients and perform laparoscopic salpingo-oophorectomy. Patients are randomly allocated in 2 groups: group A to be operated on without warm-up exercises and group B to be operated on after a short-term warm-up. All patients are operated on by the same surgical team. The full-time records of the operation were analyzed by 2 independent reviewers. Laparoscopic procedures are recorded and assessed by 2 independent observers using the generic OSATS rating scale. A training module using the Lap Sim simulator was designed for the warm-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• residents or faculty at the Dept. of Gynecology and Obstetrics

• completed skills training

Exclusion Criteria:

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Disorders

Intervention

Other:
• Preoperative Warm-Up training
Preoperative Warm-Up training

Locations

Country	Name	City	State
Austria	Dept. Gynecology and Obstetrics, Medical University of Vienna, Austria	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical performance	Surgical Performance will be assessed using Objective structured assessment of technical skills (OSATS)	During surgery

External Links

•   Surgical Skills Training Center, Medical University of Vienna