Perioperative Morbidity in Elective Surgery Based on the Time of the Year

October 19, 2022 updated by: TriHealth Inc.

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

19872

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who underwent a surgical procedure in the main operating rooms at Good Samaritan Hospital and Bethesda North Hospital

Description

Inclusion Criteria:

  • All patients aged 18 and older undergoing surgical procedures in the main operating room between July 1, 2012 and July 1, 2016.

Exclusion Criteria:

  • Patients under the age of 18
  • Procedures done outside of the main operating suites (Endoscopy suite, Labor and Delivery)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
December admission
The elective surgery group of people whose admission was the end of the calendar year (December) corresponding with insurance deductible year-end.
Non-December admission
The elective surgery group of people whose admission was between January and November.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Rachel Pauls, MD, TriHealth - Cincinnati Urogynecology Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

March 26, 2018

Study Completion (Actual)

June 8, 2018

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimated)

November 8, 2016

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

October 19, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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