Effects of Implementing an ERAS Protocol

August 17, 2023 updated by: Ridho Ardhi Syaiful

The Enhanced Recovery After Surgery (ERAS) Protocol Implementation in a National Tertiary-level Hospital: A Prospective Cohort Study

Introduction: Successful colorectal surgery is determined based on postoperative mortality and morbidity rates, complication rates, and cost-effectiveness. One of the methods to obtain an excellent postoperative outcome is the Enhanced Recovery After Surgery (ERAS) protocol. This study aims to see the effects of implementing an ERAS protocol in colorectal surgery patients.

Methods: Eighty-four patients who underwent elective colorectal surgery at National Tertiary-level Hospital were included between January 2021 and July 2022. Patients were then placed into ERAS and control groups according to the criteria. The Patients in the ERAS group underwent a customized 18-component ERAS protocol and were assessed for adherence. Postoperatively, both groups were monitored for up to 30 days and assessed for complications and readmission. The investigators then analyzed the length of stay and total patient costs in both groups.

Study Overview

Status

Completed

Conditions

Detailed Description

The investigators aimed to determine whether applying the ERAS protocol to patients undergoing colorectal surgery could improve surgical outcomes (length of stay, complications, readmission, and total costs) in the National Tertiary Hospital clinical setting.

This prospective cohort study to analyze the implementation of ERAS protocol in colorectal patients and its effect on length of stay, readmission rate, complications, and costs in Dr. Cipto Mangunkusumo General Hospital, an Indonesian tertiary-level hospital, from January 2021 to July 2022. ERAS protocol used in this study was arranged based on the guidelines of the ERAS ® Society, with certain adjustments made to fit Indonesia's population characteristics. The sampling process was performed for all patients undergoing elective colorectal surgeries in The Central Surgery Room during the study period, who continued their medical care at Integrated Medical Ward Unit and fulfilled all inclusion and exclusion criteria. In this study, the investigators also used a multidisciplinary team approach that carried out various protocol points in all phases, according to their areas of expertise. This team comprised surgeons, anesthesiologists, physical medicine, internists, rehabilitation specialists, general physicians, dietitians, nurses, pharmacists, surgery admission staff, medical record staff, and hospital administration staff.

Study participants The investigators evaluated patients in two different groups: ERAS and non-ERAS. In both groups, the investigators included patients who underwent elective/non-emergency colorectal surgery above 18 years of age, with a maximum of two different comorbidities to minimize postoperative complications, a body mass index above 18.5 kg/m2, and an ASA below 2. In the ERAS group, patients were first evaluated for eligibility for the ERAS protocol and their willingness to follow a series of ERAS protocols at the outpatient clinic of the Cipto Mangunkusumo Hospital. The Patients registered in the ERAS group followed the protocol of the ERAS research team. For the control group, patients selected through examination in the outpatient clinic would undergo conventional/traditional surgery.

The sample size was calculated using an unpaired numerical, analytical research sample size formula, with an alpha of 5%, a beta of 10%, a combined standard deviation of four based on previous studies, and an assumed mean outcome difference of 3. To obtain a minimum sample size for each group of 37 subjects.

Outcomes The primary outcomes of this study were: (1) the length of hospitalization, (2) postoperative complications, (3) readmission rate, and (4) total medical costs. The length of hospitalization was calculated from the day of admission to the hospital ward until discharge. Postoperative complications were defined as infection on the surgical site or systemic infection, wound dehiscence, and other complications found after surgery. The readmission rate was calculated from discharge to one month after surgery. Total medical costs were calculated based on direct medical costs recorded in the hospital billing data. The currency was converted from Indonesian Rupiah (IDR) to US dollars (USD) based on the September 1, 2022, conversion rate of USD 1 = IDR 14,200.

In addition, the investigators assessed the adherence of patients in the ERAS group to the ERAS protocol. Each implemented protocol component was recorded, and the number of protocols that could be implemented for each patient was calculated. The adherence to the eighteen ERAS protocols was grouped into: <90%, 90-95%, 96-100% for readmission, complications, length of stay <7 days, and costs < USD 3,000 for patients in the ERAS group based on a previous study. The controlled price of USD 3,000 is determined based on hospital's average cost of the non-ERAS group.

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10440
        • Dr. Cipto Mangunkusumo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Colorectal cancer patients undergoing surgery at Dr. Cipto Mangunkusumo General Hospital

Description

Inclusion Criteria:

  • maximum of two different comorbidities
  • body mass index above 18.5 kg/m2
  • ASA below 2

Exclusion Criteria:

  • More than 2 comorbidities
  • Refused to take part in the research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
ERAS group
Patients who met the inclusion criteria and consented were assigned to the ERAS group
control group
Patients who met the inclusion criteria and did not consent were assigned to the ERAS group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospitalization
Time Frame: day 1 until day 30
The length of hospitalization was calculated from the day of admission to the hospital ward until the discharge
day 1 until day 30
postoperative complications
Time Frame: day 1 until day 30
Postoperative complications were defined as infection on the surgical site or systemic infection, wound dehiscence, and other complications found after surgery
day 1 until day 30
readmission rate
Time Frame: day 1 until day 30
The readmission rate was calculated from discharge to one month after surgery.
day 1 until day 30
Total medical costs
Time Frame: day 1 until day 30
Total medical costs were calculated based on direct medical costs recorded in the hospital billing data. The currency was converted from Indonesian Rupiah (IDR) to US dollars (USD) based on the September 1, 2022, conversion rate of USD 1 = IDR 14,200.
day 1 until day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adherence to the ERAS protocols
Time Frame: day 1 until day 30
The adherence to the eighteen ERAS protocols was grouped into: <90%, 90-95%, 96-100% for readmission, complications, length of stay <7 days, and costs < USD 3,000 for patients in the ERAS group based on a previous study
day 1 until day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ridho Ardhi Syaiful

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

January 10, 2022

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 17, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRCiptoMGH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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