Laparoscopic Cholecystectomy Care Protocol

Compliance With Laparoscopic Cholecystectomy Care Protocol

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

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Other: Protocol Compliance

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients between the ages of 18 years and 75 years who had surgery for choledocolithiasis at Prisma Health-Upstate.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protocol Compliance	Percent compliance with protocol components	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Stay	Post acute care unit length of stay will be measured in minutes	15 months

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Investigators: Principal Investigator: William Hand, MD, Prisma Health-Upstate

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): April 1, 2021

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (ACTUAL): February 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Pro00066577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No