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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04269096
Other study ID # Pro00066577
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date April 1, 2021

Study information

Verified date April 2021
Source Prisma Health-Upstate
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol.


Description:

Evidence based medicine calls for the application of scientific advances to clinical care. In an effort to address the most common complications of a surgical procedure, perioperative protocols have recently been created in an effort to apply best practices consistently and enhance the recovery from surgery. In addition to evaluating the validity of the protocol components themselves, it is valuable to measure compliance with said protocol. Failure to complete the steps of a care pathway may be caused by several reasons, and a study of application of these steps may help future efforts at standardization of care. The purpose of this study is to determine compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol. Hospital inpatient data from patient charts, office charts, and hospital medical data systems of Prisma Health-Upstate System will be used to review the records of all patients age 18-75 years, inpatient and outpatient, who had surgery for choledocolithiasis between January 1, 2016 to April 1, 2017.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date April 1, 2021
Est. primary completion date April 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients between the ages of 18 years and 75 years who had surgery for choledocholithiasis at Prisma Health-Upstate. Exclusion Criteria: - Patients under 18 years of age and older than 75 years of age.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Protocol Compliance
Compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol

Locations

Country Name City State
United States Greenville Memorial Hospital Greenville South Carolina

Sponsors (1)

Lead Sponsor Collaborator
Prisma Health-Upstate

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Protocol Compliance Percent compliance with protocol components 15 months
Secondary Length of Stay Post acute care unit length of stay will be measured in minutes 15 months
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