Viewing Study NCT03968666


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Ignite Modification Date: 2025-12-24 @ 4:02 PM
Study NCT ID: NCT03968666
Status: UNKNOWN
Last Update Posted: 2022-02-15
First Post: 2019-05-28
Is Possible Gene Therapy: False
Has Adverse Events: False

Brief Title: Compliance With Enhanced Recovery After Surgery Protocol (ERAS) in Surgical Patients
Sponsor: Augusta University
Organization:

Study Overview

Official Title: Evaluation of Compliance With Enhanced Recovery After Surgery (ERAS) Protocol in Benign Gynecological Surgical Patients
Status: UNKNOWN
Status Verified Date: 2022-02
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The concept of "enhanced recovery" was introduced by European anesthesiologists and surgeons who challenged traditional clinical practices involved in peri-operative care in 1990s. The goal of enhanced recovery programs (ERP) is to maintain normal physiology thereby decreasing complications. It focuses on peri-operative optimization of patient care. It was originally created for open colorectal surgeries but now has shown benefit in various surgical specialities including thoracic surgery, vascular surgery, hepatobiliary as well as gynecological surgery.

The successful implementation of structured ERAS program requires an ERAS protocol, audit system and a multidisciplinary team. The investigators will evaluate the effect of compliance with the protocol and outcomes such as length of stay, readmissions, morbidity and mortality.
Detailed Description: After approval by the Institutional Review Board, the investigators plan to retrospectively study gynecological patients who underwent ERAS protocol at Augusta University Medical Center between January 2017 and February 2019.

This is a retrospective observational study to evaluate the outcomes of patients who had ERAS protocol during their surgery.

Demographic and outcome variables will be obtained from the institutional health documentation system. The investigators will collect demographic variables (age, ASA status), morphometric measurements (body mass index), time from enrollment to ERAS protocol, hospitalization length of stay, and readmission rate. The investigators will also record the documentation of the ERAS protocol interventions against the ERAS protocol approved by the institution. The investigators will assess the effect of the degree of compliance on outcome variables.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: