NCT03968666

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

May 28, 2019

Last Update Submit

February 14, 2022

Conditions

SurgeryAnesthesia

Outcome Measures

Primary Outcomes (1)

  • Length of stay

    Days from surgery to discharge from the hospital

    2 weeks

Secondary Outcomes (2)

  • Readmission

    2 weeks

  • Mortality

    2 weeks

Study Arms (1)

Gynecological surgery with ERAS protocol

Patients scheduled for benign gynecological surgery under ERAS protocol

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGynecological surgery
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for benign gynecologic surgery who underwent ERAS protocol

You may qualify if:

  • All elective benign gynecological surgical patients enrolled under ERAS protocol

You may not qualify if:

  • History of oncologic pathologies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

RECRUITING

Study Officials

  • Efrain Riveros Perez, MD

    Augusta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Efrain Riveros Perez, MD

CONTACT

3304074681eriverosperez@augusta.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 28, 2019

First Posted

May 30, 2019

Study Start

June 1, 2019

Primary Completion

September 30, 2022

Study Completion

October 31, 2022

Last Updated

February 15, 2022

Record last verified: 2022-02

Locations

US(1)