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

Surgery Clinical Trial

Official title:

Evaluation of Compliance With Enhanced Recovery After Surgery (ERAS) Protocol in Benign Gynecological Surgical Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03968666
• Other study ID #: 1396793
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: October 31, 2022

Study information

• Verified date: February 2022
• Source: Augusta University
• Contact: Efrain Riveros Perez, MD
• Phone: 3304074681
• Email: eriverosperez[@]augusta.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All elective benign gynecological surgical patients enrolled under ERAS protocol

Exclusion Criteria:

• History of oncologic pathologies

Related Conditions & MeSH terms

• Anesthesia
• Surgery

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Augusta University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Days from surgery to discharge from the hospital	2 weeks
Secondary	Readmission	Admission to hospital after discharge	2 weeks
Secondary	Mortality	Number of fatalities after surgery	2 weeks