NCT02958293

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19,872

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2018

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

September 1, 2023

Completed
Last Updated

September 1, 2023

Status Verified

October 1, 2022

Enrollment Period

1.4 years

First QC Date

November 2, 2016

Results QC Date

October 19, 2022

Last Update Submit

October 19, 2022

Conditions

Perioperative Complication

Outcome Measures

Primary Outcomes (1)

  • 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.

    90 days after surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Dr. Rachel Pauls
Organization
TriHealth Inc.
Rachel_Pauls@trihealth.com
513-463-4300

Study Officials

  • Rachel Pauls, MD

    TriHealth - Cincinnati Urogynecology Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 8, 2016

Study Start

November 1, 2016

Primary Completion

March 26, 2018

Study Completion

June 8, 2018

Last Updated

September 1, 2023

Results First Posted

September 1, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share