Preoperative Warm-up in Gynecologic Surgery | NCT01712607

Studies
Preoperative Warm-up in Gynecologic Surgery

NCT01712607

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Jun 16, 2015Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Gynecologic Disorders

Interventions

Preoperative Warm-Up training

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Mar 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Oct 20, 2012

First Submission Date that Met QC Criteria

Oct 22, 2012

First Posted Date

Oct 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2015

Last Update Posted Date

Jun 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Preoperative Warm-Up training	Other	Preoperative Warm-Up training	Warm-Up

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical performance	Surgical Performance will be assessed using Objective structured assessment of technical skills (OSATS)	During surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephan Polterauer	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. Gynecology and Obstetrics, Medical University of Vienna, Austria		Vienna	State of Vienna	1090	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26778744	Derived	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.

Type	Date	Date Unknown
Release	Oct 30, 2016
Reset	Dec 27, 2016

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases