Operating Room EfficiencyNCT03257384
Minimizing Peri-operative Time Delays, Maximizing Operating Room Efficiency: A Pilot Study
An observational study of Operating Room Efficiency, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Operating Room Efficiency
- What is being tested?
- Black box recording of surgery
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 10 Aug 2017to 6 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Total laparoscopic hysterectomy cases performed by Minimally Invasive Surgery gynecologist at St. Michael's Hospital
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Operating Room Efficiency
- Being tested
- Black box recording of surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black box recording of surgeryOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative room time delays
Time delays during a total laparoscopic hysterectomy procedure will be recorded
Measured: 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
Measured: From time when patient enters operating room to time when they exit the room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start10 Aug 2017
- Primary completion6 Aug 2021
- Study completion6 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Operating Room EfficiencyStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eliane Shore, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257384
- Sponsor's protocol ID
- 17-029
- Status last verified
- Dec 2023
- First submitted
- 17 Aug 2017
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing Peri-operative Time Delays, Maximizing Operating Room Efficiency: A Pilot Study
- ClinicalTrials.gov ID
- NCT03257384
- Acronym / sponsor ID
- 17-029
- Conditions
- Operating Room Efficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 6 Aug 2021 (actual)
- Study completion
- 6 Aug 2021 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Total laparoscopic hysterectomy cases performed by Minimally Invasive Surgery gynecologist at St. Michael's Hospital
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black box recording of surgeryTime delays will be recorded from the moment the patient is draped and enters the operating room to the moment they exit the operating room. | Other | – |
Primary outcome
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
1 secondary outcome
Non-technical skills and performance of operative team
Time frame: From time when patient enters operating room to time when they exit the room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliane Shore, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Operating Room Efficiency, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative room time delays (time frame: Recording starts when patient enters operating room and ends when they exit the room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.