Enhanced Recovery After SurgeryNCT06065696
Enhanced Recovery After Surgery Protocol on Early Mobilization After Colorectal Surgery
An observational study of Enhanced Recovery After Surgery and Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Enhanced Recovery After Surgery, Anesthesia, Surgery-Complications
- What is being tested?
- Early mobilization and No early mobilization
- Type of treatment
- Surgery or procedure
- How many people
- 343 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Feb 2023to 30 Apr 2023
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: All patients underwent colorectal surgery in Cipto Mangunkusumo Hospital during 2020 to 2022
Who may be able to join
- 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
Who cannot join
- Patients who were not intubated on postoperative period
- Patients who had physical limitation during preoperative mobility test
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Central National Hospital
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: 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.
Read the 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).
- Conditions
- Enhanced Recovery After Surgery, Anesthesia, Surgery-Complications, Colorectal, Early Mobilization
- Being tested
- Early mobilization, No early mobilization
- Keywords
- early mobilization, Enhanced Recovery After Surgery, PONV prophylaxis, fluid management, pain management
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early mobilizationProcedure or surgery
Patients who received early mobilization in postoperative period
No early mobilizationProcedure or surgery
Patients who did not receive early mobilization in postoperative period
| Study group | Role | What they receive |
|---|---|---|
| Early mobilization | Patients who achieved early mobilization after colorectal surgery Receives: Procedure: Early mobilization | |
| No early mobilization | Patients who did not achieve early mobilization after colorectal surgery Receives: Procedure: No early mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early mobilization
Number of patients who can walk within 24 hours after surgery
Measured: Within 24 hours after surgery
PONV prophylaxis
Number of patients who received prophylaxis given for PONV
Measured: Given during intraoperative period
Multimodal analgesia
Number of patients who got multimodal analgesia, which consists of epidural anesthesia or peripheral nerve block
Measured: Given during intraoperative period
Intraoperative fluid management
Number of patients who achieved fluid balance of zero or near zero
Measured: Given during intraoperative period
Postoperative pain management
Number of patients who received postoperative pain management without opioid
Measured: Immediately after surgery until discharge, assessed until hospital discharge, up to 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Feb 2023
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aldy Heriwardito, Universitas Indonesia
- Investigators
- Aldy Heriwardito, Consultant, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065696
- Sponsor's protocol ID
- IndonesiaUAnes112
- Status last verified
- Sep 2023
- First submitted
- 31 Jul 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With Enhanced Recovery After Surgery Protocol on Early Mobilization After Colorectal Surgery in Tertiary Hospital in Indonesia
- ClinicalTrials.gov ID
- NCT06065696
- Acronym / sponsor ID
- IndonesiaUAnes112
- Conditions
- Enhanced Recovery After Surgery, Anesthesia, Surgery-Complications, Colorectal, Early Mobilization
- Keywords
- early mobilization, Enhanced Recovery After Surgery, PONV prophylaxis, fluid management, pain management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 4 Oct 2023 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early mobilization | – | Procedure: Early mobilizationPatients who achieved early mobilization after colorectal surgery |
| No early mobilization | – | Procedure: No early mobilizationPatients who did not achieve early mobilization after colorectal surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients underwent colorectal surgery in Cipto Mangunkusumo Hospital during 2020 to 2022
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who were not intubated on postoperative period
- Patients who had physical limitation during preoperative mobility test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early mobilizationPatients who received early mobilization in postoperative period | Procedure or surgery | Early mobilization |
| No early mobilizationPatients who did not receive early mobilization in postoperative period | Procedure or surgery | No early mobilization |
Primary outcome
Early mobilization
Time frame: Within 24 hours after surgery
Number of patients who can walk within 24 hours after surgery
PONV prophylaxis
Time frame: Given during intraoperative period
Number of patients who received prophylaxis given for PONV
Multimodal analgesia
Time frame: Given during intraoperative period
Number of patients who got multimodal analgesia, which consists of epidural anesthesia or peripheral nerve block
Intraoperative fluid management
Time frame: Given during intraoperative period
Number of patients who achieved fluid balance of zero or near zero
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Aldy Heriwardito, Consultant principal investigator
Universitas Indonesia
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 Enhanced Recovery After Surgery and Anesthesia, run by Universitas Indonesia at 1 site in Indonesia.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 4 Oct 2023. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early mobilization (time frame: Within 24 hours after surgery). The study lists 5 primary outcomes in all. 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 4 Oct 2023.