Perioperative ComplicationNCT02958293
Perioperative Morbidity in Elective Surgery Based on the Time of the Year
An observational study of Perioperative Complication, run by TriHealth Inc..
Trial summary
This is a retrospective cohort study using Electronic Privacy Identification Center (EPIC) database to evaluate if there are any differences in perioperative morbidity for elective surgery based on the time of the year surgery is performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Complication
- How many people
- 19,872 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to 8 Jun 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who underwent a surgical procedure in the main operating rooms at Good Samaritan Hospital and Bethesda North Hospital
Who may be able to join
- All patients aged 18 and older undergoing surgical procedures in the main operating room between July 1, 2012 and July 1, 2016.
Who cannot join
- Patients under the age of 18
- Procedures done outside of the main operating suites (Endoscopy suite, Labor and Delivery)
About this study
Official title: Does Procedural Timing Impact Perioperative Morbidity in Elective Surgery?
This is a retrospective cohort study using Electronic Privacy Identification Center (EPIC) database to evaluate if there are any differences in perioperative morbidity for elective surgery based on the time of the year surgery is performed.
Read the detailed description
Surgical complications are a significant cause of morbidity and mortality. Surgical complications account for up to 40% of hospital complications. Complications and adverse events are also becoming increasingly important for measuring health care quality.
Many physician practices notice a surge of patients seeking care at the end of the year compared to other times of the year. Patients who meet their insurance deductibles are likely more eager to proceed with an elective procedure. Patients who have met their deductible likely utilize more healthcare resources because they have more health problems, or have had more procedures performed during that year. Thus there may be potential for sicker and more complicated patients to undergo surgery at the end of the year as compared to other times of the year.
Prior studies have often evaluated the "July effect" which is the beginning of a new academic year at teaching hospitals. Not only are new interns involved in patient care but trainees at all levels are in participating in a new role. Several prior studies have found high morbidity and mortality rates in July-August compared to April-June. There is paucity of research evaluating the measures for the months of November-December.
Identifying which patients are at a higher risk for perioperative morbidity is important to help prevent surgical complications and lower healthcare costs. Proper patient selection and appropriate timing for elective procedures will positively impact these adverse outcomes.
This study is a retrospective cohort study investigating whether there are differences in perioperative morbidity for elective surgery based on the time of the year surgery is performed. The results of this project could impact counseling for patient regarding timing of their surgery based on calendar month. This could also help implement changes in how systems based care is provided regarding insurance deductibles and maximums.
- Conditions
- Perioperative Complication
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Surgical Complication
All patients 18 years and older who underwent a surgical procedure in the main operating rooms at Good Samaritan Hospital and Bethesda North Hospital between January 1, 2015 and December 31, 2016.
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion26 Mar 2018
- Study completion8 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 19,872 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Pauls, MD, Principal investigator, TriHealth - Cincinnati Urogynecology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958293
- Sponsor's protocol ID
- 16-049
- Status last verified
- Oct 2022
- First submitted
- 2 Nov 2016
- Last updated
- 1 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Procedural Timing Impact Perioperative Morbidity in Elective Surgery?
- ClinicalTrials.gov ID
- NCT02958293
- Acronym / sponsor ID
- 16-049
- Conditions
- Perioperative Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19,872 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Nov 2016
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 8 Jun 2018 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Posted 1 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective cohort study using Electronic Privacy Identification Center (EPIC) database to evaluate if there are any differences in perioperative morbidity for elective surgery based on the time of the year surgery is performed.
Detailed description
Surgical complications are a significant cause of morbidity and mortality. Surgical complications account for up to 40% of hospital complications. Complications and adverse events are also becoming increasingly important for measuring health care quality.
Many physician practices notice a surge of patients seeking care at the end of the year compared to other times of the year. Patients who meet their insurance deductibles are likely more eager to proceed with an elective procedure. Patients who have met their deductible likely utilize more healthcare resources because they have more health problems, or have had more procedures performed during that year. Thus there may be potential for sicker and more complicated patients to undergo surgery at the end of the year as compared to other times of the year.
Prior studies have often evaluated the "July effect" which is the beginning of a new academic year at teaching hospitals. Not only are new interns involved in patient care but trainees at all levels are in participating in a new role. Several prior studies have found high morbidity and mortality rates in July-August compared to April-June. There is paucity of research evaluating the measures for the months of November-December.
Identifying which patients are at a higher risk for perioperative morbidity is important to help prevent surgical complications and lower healthcare costs. Proper patient selection and appropriate timing for elective procedures will positively impact these adverse outcomes.
This study is a retrospective cohort study investigating whether there are differences in perioperative morbidity for elective surgery based on the time of the year surgery is performed. The results of this project could impact counseling for patient regarding timing of their surgery based on calendar month. This could also help implement changes in how systems based care is provided regarding insurance deductibles and maximums.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who underwent a surgical procedure in the main operating rooms at Good Samaritan Hospital and Bethesda North Hospital
Key inclusion criteria (1 listed)
- All patients aged 18 and older undergoing surgical procedures in the main operating room between July 1, 2012 and July 1, 2016.
Key exclusion criteria (2 listed)
- Patients under the age of 18
- Procedures done outside of the main operating suites (Endoscopy suite, Labor and Delivery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Surgical Complication
Time frame: 90 days after surgery
All patients 18 years and older who underwent a surgical procedure in the main operating rooms at Good Samaritan Hospital and Bethesda North Hospital between January 1, 2015 and December 31, 2016.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Rachel Pauls, MD principal investigator
TriHealth - Cincinnati Urogynecology Associates
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Complication, run by TriHealth Inc..
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 2 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 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 1 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Surgical Complication (time frame: 90 days after surgery). 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 1 Sep 2023.