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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03257384
Other study ID # 17-029
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 10, 2017
Est. completion date August 6, 2021

Study information

Verified date December 2023
Source Unity Health Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective is to prospectively identify Operating Room (OR) time delays from the time the patient who is undergoing total laparoscopic hysterectomy enters the OR to exiting the OR. This analysis will be used to identify root cause(s) leading to OR delays and define areas for improvement. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date August 6, 2021
Est. primary completion date August 6, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Black box recording of surgery
Time delays will be recorded from the moment the patient is draped and enters the operating room to the moment they exit the operating room.

Locations

Country Name City State
Canada St. Michael's Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Operative room time delays 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 Non-technical skills and performance of operative team 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