Enhanced Recovery After Surgery Protocol on Early Mobilization After Colorectal Surgery

September 30, 2023 updated by: Aldy Heriwardito, Indonesia University

Compliance With Enhanced Recovery After Surgery Protocol on Early Mobilization After Colorectal Surgery in Tertiary Hospital in Indonesia

Early mobilization is an important factor in increasing postoperative colorectal surgeries outcome. There are four components held by anesthesiologist in Enhanced Recovery After Surgery protocol for colorectal surgery in our hospital: post operative nausea and vomiting (PONV) prophylaxis, intraoperative fluid management, intraoperative multimodal analgesia, and postoperative opioid-free pain management. Although early mobilization affected by postoperative pain, vomiting and nausea, and fluid balance management, nonetheless, there is no clear evidence of how much each of these components will affect early mobilization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Early mobilization is an important factor in increasing postoperative colorectal surgeries outcome. There are four components held by anesthesiologist in ERAS protocol for colorectal surgery in our hospital: PONV prophylaxis, intraoperative fluid management, intraoperative multimodal analgesia, and postoperative opioid-free pain management. Although early mobilization affected by postoperative pain, vomiting and nausea, and fluid balance management, nonetheless, there is no clear evidence of how much each of these components will affect early mobilization. This study was a retrospective cohort study by collecting secondary data from patients underwent elective colorectal surgery in our hospital from January 2020 to December 2022. The outcomes assessed were early mobilization rate and factors affecting it (PONV prophylaxis, intraoperative fluid management, intraoperative multimodal analgesia, and postoperative opioid-free pain management).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
343

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, 10430
        • Cipto Mangunkusumo Central National 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients underwent colorectal surgery in Cipto Mangunkusumo Hospital during 2020 to 2022

Description

Inclusion criteria

  • Patient underwent colorectal surgery in Cipto Mangunkusumo Hospital from 2020 to 2022
  • Age 18-60 years old
  • American Society of Anesthesiologist (ASA) physical status 1, 2, and 3

Exclusion criteria

  • Patients who were not intubated on postoperative period
  • Patients who had physical limitation during preoperative mobility test

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Early mobilization
Patients who achieved early mobilization after colorectal surgery
Procedure: Early mobilization
Patients who received early mobilization in postoperative period
No early mobilization
Patients who did not achieve early mobilization after colorectal surgery
Procedure: No early mobilization
Patients who did not receive early mobilization in postoperative period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Early mobilization
Time Frame: Within 24 hours after surgery
Number of patients who can walk within 24 hours after surgery
Within 24 hours after surgery
PONV prophylaxis
Time Frame: Given during intraoperative period
Number of patients who received prophylaxis given for PONV
Given during intraoperative period
Multimodal analgesia
Time Frame: Given during intraoperative period
Number of patients who got multimodal analgesia, which consists of epidural anesthesia or peripheral nerve block
Given during intraoperative period
Intraoperative fluid management
Time Frame: Given during intraoperative period
Number of patients who achieved fluid balance of zero or near zero
Given during intraoperative period
Postoperative pain management
Time Frame: Immediately after surgery until discharge, assessed until hospital discharge, up to 50 days
Number of patients who received postoperative pain management without opioid
Immediately after surgery until discharge, assessed until hospital discharge, up to 50 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indonesia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aldy Heriwardito, Consultant, Indonesia University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IndonesiaUAnes112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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