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CompletedNCT03257384Updated Dec 19, 2023

Minimizing Peri-operative Time Delays, Maximizing Operating Room Efficiency: A Pilot Study

An observational study in Operating Room Efficiency, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2023-12-19.

Sponsored by Unity Health Toronto · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Operating Room Efficiency
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will include: patients undergoing total laparoscopic hysterectomy, as well as the surgeons, anesthesiologists, and nurses involved in conducting the surgery.

Inclusion criteria

  • Total laparoscopic hysterectomy cases performed by Minimally Invasive Surgery gynecologist at St. Michael's Hospital

Exclusion criteria

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)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Interventions

  • OtherBlack 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.

05

What researchers measure

Primary outcomes

  1. Operative room time delays

    Time delays during a total laparoscopic hysterectomy procedure will be recorded

    Time frame: Recording starts when patient enters operating room and ends when they exit the room

Secondary outcomes

  1. Non-technical skills and performance of operative team

    Skills and team performance will be rated using the Oxford NOTECHS Rating Scale

    Time frame: From time when patient enters operating room to time when they exit the room

06

Study locations

1 site
  • St. Michael's Hospital
    Toronto, Ontario, Canada
07

References and documents

Study documents

  • Study protocol · Feb 27, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03257384
Lead sponsor
Unity Health Toronto
Responsible party
Sponsor
First posted
Aug 22, 2017
Start date
Aug 10, 2017
Primary completion
Aug 6, 2021
Completion
Aug 6, 2021
Last update
Dec 19, 2023

Study contacts

Eliane Shore, MD
principal investigator · Unity Health Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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