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Preoperative Warm-up in Gynecologic Surgery

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ClinicalTrials.gov Identifier: NCT01712607
Recruitment Status : Completed
First Posted : October 23, 2012
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Gynecologic Disorders Other: Preoperative Warm-Up training Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preoperative Warm-up in Gynecologic Surgery Using a Virtual Reality Simulator.
Study Start Date : October 2012
Primary Completion Date : March 2014
Study Completion Date : April 2014
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Surgical performance [ Time Frame: During surgery ]
    Surgical Performance will be assessed using Objective structured assessment of technical skills (OSATS)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01712607


Locations
Austria
Dept. Gynecology and Obstetrics, Medical University of Vienna, Austria
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Stephan Polterauer Medical University of Vienna
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stephan Polterauer, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01712607     History of Changes
Other Study ID Numbers: Warm-Up-1.0
First Posted: October 23, 2012    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms:
Genital Diseases, Female