Preoperative Warm-up in Gynecologic Surgery

This study is currently recruiting participants. (see Contacts and Locations)
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014