SurgeryNCT03968666
Compliance With Enhanced Recovery After Surgery Protocol (ERAS) in Surgical Patients
An observational study of Surgery and Anesthesia, run by Augusta University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgery, Anesthesia
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for benign gynecologic surgery who underwent ERAS protocol
Who may be able to join
- All elective benign gynecological surgical patients enrolled under ERAS protocol
Who cannot join
- History of oncologic pathologies
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30912
Steffen Meiler, MD, 706-721-3671, smeiler@augusta.edu
About this study
Official title: Evaluation of Compliance With Enhanced Recovery After Surgery (ERAS) Protocol in Benign Gynecological Surgical Patients
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.
Read the 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.
- Conditions
- Surgery, Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gynecological surgery with ERAS protocol | Patients scheduled for benign gynecological surgery under ERAS protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Days from surgery to discharge from the hospital
Measured: 2 weeks
Secondary outcomes (2)
Readmission
Admission to hospital after discharge
Measured: 2 weeks
Mortality
Number of fatalities after surgery
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start1 Jun 2019
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efrain Riveros Perez, MD, Augusta University
- Investigators
- Efrain Riveros Perez, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968666
- Sponsor's protocol ID
- 1396793
- Status last verified
- Feb 2022
- First submitted
- 28 May 2019
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Compliance With Enhanced Recovery After Surgery (ERAS) Protocol in Benign Gynecological Surgical Patients
- ClinicalTrials.gov ID
- NCT03968666
- Acronym / sponsor ID
- 1396793
- Conditions
- Surgery, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynecological surgery with ERAS protocol | – | –Patients scheduled for benign gynecological surgery under ERAS protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for benign gynecologic surgery who underwent ERAS protocol
Key inclusion criteria (1 listed)
- All elective benign gynecological surgical patients enrolled under ERAS protocol
Key exclusion criteria (1 listed)
- History of oncologic pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of stay
Time frame: 2 weeks
Days from surgery to discharge from the hospital
2 secondary outcomes
Readmission
Time frame: 2 weeks
Mortality
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Efrain Riveros Perez, MD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Anesthesia, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Efrain Riveros Perez, MD (3304074681, eriverosperez@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.