- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06065696
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Early mobilization
Patients who achieved early mobilization after colorectal surgery
|
Patients who received early mobilization in postoperative period
|
|
No early mobilization
Patients who did not achieve early mobilization after colorectal surgery
|
Patients who did not receive early mobilization in postoperative period
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- 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)
February 1, 2023
Primary Completion (Actual)
April 30, 2023
Study Completion (Actual)
April 30, 2023
Study Registration Dates
First Submitted
July 31, 2023
First Submitted That Met QC Criteria
September 30, 2023
First Posted (Actual)
October 4, 2023
Study Record Updates
Last Update Posted (Actual)
October 4, 2023
Last Update Submitted That Met QC Criteria
September 30, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID 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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