Preoperative Warm-up in Gynecologic Surgery

NCT ID: NCT01712607

Last Updated: 2015-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gynecologic Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Warm-Up

Surgery after warm-up task Preoperative Warm-Up training

Group Type EXPERIMENTAL

Preoperative Warm-Up training

Intervention Type OTHER

Preoperative Warm-Up training

No Warm-up

Surgery without warm-up exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Preoperative Warm-Up training

Preoperative Warm-Up training

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stephan Polterauer

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephan Polterauer

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Vienna, Vienna, Austria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Austria

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26778744 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.meduniwien.ac.at/SSTC/

Surgical Skills Training Center, Medical University of Vienna

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Warm-Up-1.0

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.