- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03257384
Minimizing Peri-operative Time Delays, Maximizing Operating Room Efficiency: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Time delays in the operating room play a role in increasing wait time length, number of cancelled cases, health care expenditure and resources. Furthermore, it inconveniences patients and families, and delays care. Minimally invasive surgery (laparoscopy) affords same-day discharge, faster recovery, and decreased morbidity. However, performing laparoscopy requires special equipment and multiple steps during set-up that can lead to time delays if not performed efficiently. Multiple factors have been identified to contribute to inefficient care delivery including: communication error, equipment failure, lack of teamwork among nursing, surgical or anesthesia teams, and duplication of tasks.
OR delays due to inefficiency can result from a chain of intraoperative events including technical factors (ie. equipment failure or case complexity) and from non-technical human factors (ie. communication errors or lack of coordinated teamwork within and between OR teams). "The intraoperative period is the period in which the surgical team may have the most influence" on efficiency. Objective measures of intraoperative OR delays and identification of their causes can lead to the development of a standardized framework that could be generalized to any surgical discipline to improve OR efficiency.
The primary objective of this study is to prospectively identify OR time delays from the time the patient enters the OR who are undergoing total laparoscopic hysterectomy (laparoscopic gynecologic procedure that involves several potential areas for inefficiency) to case completion and exiting the OR. This analysis will be used to identify root cause(s) leading to OR delays and define areas for improvement. The causes of delays can be reported back to the team members through formative performance-based feedback. The secondary objective is to identify any improvements in OR time delays and OR utilization following implementation of a standardized framework developed to increase OR efficiency.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- St. Michael's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Total laparoscopic hysterectomy cases performed by Minimally Invasive Surgery gynecologist at St. Michael's Hospital
Exclusion Criteria:
- Procedure converted to laparotomy
- Patients who desire future child bearing potential
- Procedures performed by hysteroscopy or laparotomy
- General gynecologist surgeon (i.e. non-Minimally Invasive Surgical specialist)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative room time delays
Time Frame: Recording starts when patient enters operating room and ends when they exit the room
|
Time delays during a total laparoscopic hysterectomy procedure will be recorded
|
Recording starts when patient enters operating room and ends when they exit the room
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Non-technical skills and performance of operative team
Time Frame: From time when patient enters operating room to time when they exit the room
|
Skills and team performance will be rated using the Oxford NOTECHS Rating Scale
|
From time when patient enters operating room to time when they exit the room
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eliane Shore, MD, Unity Health Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 17-029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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