Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laparoscopic Cholecystectomy Care Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04269096
Recruitment Status : Active, not recruiting
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Prisma Health-Upstate

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

Condition or disease Intervention/treatment
Laparoscopic Cholecystectomy 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Compliance With Laparoscopic Cholecystectomy Care Protocol
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : April 1, 2017
Estimated Study Completion Date : April 1, 2020

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


Primary Outcome Measures :
  1. Protocol Compliance [ Time Frame: 15 months ]
    Percent compliance with protocol components


Secondary Outcome Measures :
  1. Length of Stay [ Time Frame: 15 months ]
    Post acute care unit length of stay will be measured in minutes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients between the ages of 18 years and 75 years who had surgery for choledoclithiasis at GHS.
Criteria

Inclusion Criteria:

  • Patients between the ages of 18 years and 75 years who had surgery for choledoclithiasis at GHS.

Exclusion Criteria:

  • Patients under 18 years of age and older than 75 years of age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269096


Locations
Layout table for location information
United States, South Carolina
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Prisma Health-Upstate
Investigators
Layout table for investigator information
Principal Investigator: William Hand, MD Prisma Health-Upstate

Layout table for additonal information
Responsible Party: Prisma Health-Upstate
ClinicalTrials.gov Identifier: NCT04269096    
Other Study ID Numbers: Pro00066577
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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