Preoperative Warm-up in Gynecologic Surgery

This study is currently recruiting participants.
Verified April 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Stephan Polterauer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01712607
First received: October 20, 2012
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Gynecologic Disorders
Other: Preoperative Warm-Up training
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Warm-up in Gynecologic Surgery Using a Virtual Reality Simulator.

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Surgical performance [ Time Frame: During surgery ] [ Designated as safety issue: Yes ]
    Surgical Performance will be assessed using Objective structured assessment of technical skills (OSATS)


Estimated Enrollment: 20
Study Start Date: October 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Warm-Up
Surgery after warm-up task Preoperative Warm-Up training
Other: Preoperative Warm-Up training
Preoperative Warm-Up training
No Intervention: No Warm-up
Surgery without warm-up exercise

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712607

Contacts
Contact: Stephan Polterauer, MD +436769773524 stephan.polterauer@meduniwien.ac.at
Contact: Christoph Grimm, MD +431404002962 christoph.grimm@meduniwien.ac.at

Locations
Austria
Dept. Gynecology and Obstetrics, Medical University of Vienna, Austria Recruiting
Vienna, Austria, 1090
Contact: Stephan Polterauer, MD    +43140400 ext 2938    stephan.polterauer@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Stephan Polterauer Medical University of Vienna
  More Information

Additional Information:
No publications provided

Responsible Party: Stephan Polterauer, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01712607     History of Changes
Other Study ID Numbers: Warm-Up-1.0
Study First Received: October 20, 2012
Last Updated: April 29, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
laparoscopy
surgery
warm-up
preoperative
surgical skills

Additional relevant MeSH terms:
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014