Preoperative Warm-up in Gynecologic Surgery
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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. |
- 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 |
Inclusion Criteria:
- residents or faculty at the Dept. of Gynecology and Obstetrics
- completed skills training
Exclusion Criteria:
- none
Contacts and Locations| Contact: Stephan Polterauer, MD | +436769773524 | stephan.polterauer@meduniwien.ac.at |
| Contact: Christoph Grimm, MD | +431404002962 | christoph.grimm@meduniwien.ac.at |
| 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 | |
| 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 May 16, 2013