Preoperative Warm-up in Gynecologic Surgery

NCT01712607 | Completed Phase 1

• 1 other identifier: Warm-Up-1.0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Disorders

Keywords

laparoscopy; surgery; warm-up; preoperative; surgical skills

Outcome Measures

Primary Outcomes (1)

• Surgical performance

  Surgical Performance will be assessed using Objective structured assessment of technical skills (OSATS)

  During surgery

Study Arms (2)

Warm-Up

EXPERIMENTAL

Surgery after warm-up task Preoperative Warm-Up training

Other: Preoperative Warm-Up training

No Warm-up

NO INTERVENTION

Surgery without warm-up exercise

Interventions

Preoperative Warm-Up training OTHER

Preoperative Warm-Up training

Warm-Up

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• none

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Dept. Gynecology and Obstetrics, Medical University of Vienna, Austria

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

• Polterauer S, Husslein H, Kranawetter M, Schwameis R, Reinthaller A, Heinze G, Grimm C. Effect of Preoperative Warm-up Exercise Before Laparoscopic Gynecological Surgery: A Randomized Trial. J Surg Educ. 2016 May-Jun;73(3):429-32. doi: 10.1016/j.jsurg.2015.11.017. Epub 2016 Jan 14.

  PMID: 26778744 DERIVED

Related Links

• Surgical Skills Training Center, Medical University of Vienna

MeSH Terms

Conditions

Genital Diseases, Female

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Stephan Polterauer

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 20, 2012
• First Posted: October 23, 2012
• Study Start: October 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 16, 2015

Record last verified: 2015-06

Locations

AU (1)