NCT04269096

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 13, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

1.2 years

First QC Date

February 11, 2020

Last Update Submit

April 12, 2021

Conditions

Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

  • Protocol Compliance

    Percent compliance with protocol components

    15 months

Secondary Outcomes (1)

  • Length of Stay

    15 months

Interventions

Protocol ComplianceOTHER

Compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greenville Memorial Hospital

Greenville, South Carolina, 29605, United States

Location

MeSH Terms

Interventions

Guideline Adherence

Intervention Hierarchy (Ancestors)

Quality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Officials

  • William Hand, MD

    Prisma Health-Upstate

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 13, 2020

Study Start

January 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2021

Last Updated

April 13, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)