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Compliance With Enhanced Recovery After Surgery Protocol (ERAS) in Surgical Patients

Sponsor
Augusta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03968666
Collaborator
(none)
100
Enrollment
1
Location
41
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Evaluation of Compliance With Enhanced Recovery After Surgery (ERAS) Protocol in Benign Gynecological Surgical Patients
    Actual Study Start Date :
    Jun 1, 2019
    Anticipated Primary Completion Date :
    Sep 30, 2022
    Anticipated Study Completion Date :
    Oct 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Gynecological surgery with ERAS protocol

    Patients scheduled for benign gynecological surgery under ERAS protocol

    Outcome Measures

    Primary Outcome Measures

    1. Length of stay [2 weeks]

      Days from surgery to discharge from the hospital

    Secondary Outcome Measures

    1. Readmission [2 weeks]

      Admission to hospital after discharge

    2. Mortality [2 weeks]

      Number of fatalities after surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All elective benign gynecological surgical patients enrolled under ERAS protocol
    Exclusion Criteria:
    • History of oncologic pathologies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Augusta University Augusta Georgia United States 30912

    Sponsors and Collaborators

    • Augusta University

    Investigators

    • Principal Investigator: Efrain Riveros Perez, MD, Augusta University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Efrain Riveros Perez, MD, Assistant Professor, Augusta University
    ClinicalTrials.gov Identifier:
    NCT03968666
    Other Study ID Numbers:
    • 1396793
    First Posted:
    May 30, 2019
    Last Update Posted:
    Feb 15, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 15, 2022