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CompletedNCT06065696Updated Oct 4, 2023

Enhanced Recovery After Surgery Protocol on Early Mobilization After Colorectal Surgery

An observational study in Enhanced Recovery After Surgery, Anesthesia and Surgery-Complications, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-10-04.

Sponsored by Indonesia University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
343
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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).

02

Conditions studied

  • Enhanced Recovery After Surgery
  • Anesthesia
  • Surgery-Complications
  • Colorectal
  • Early Mobilization

Keywords

  • early mobilization
  • Enhanced Recovery After Surgery
  • PONV prophylaxis
  • fluid management
  • pain management
03

In context

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion criteria

  • Patients who were not intubated on postoperative period
  • Patients who had physical limitation during preoperative mobility test
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
343 participants (actual)
Patient registry
No

Groups and cohorts

  • Early mobilization

    Patients who achieved early mobilization after colorectal surgery

    Procedure: Early mobilization

  • No early mobilization

    Patients who did not achieve early mobilization after colorectal surgery

    Procedure: No early mobilization

Interventions

  • ProcedureEarly mobilization

    Patients who received early mobilization in postoperative period

  • ProcedureNo early mobilization

    Patients who did not receive early mobilization in postoperative period

06

What researchers measure

Primary outcomes

  1. Early mobilization

    Number of patients who can walk within 24 hours after surgery

    Time frame: Within 24 hours after surgery

  2. PONV prophylaxis

    Number of patients who received prophylaxis given for PONV

    Time frame: Given during intraoperative period

  3. Multimodal analgesia

    Number of patients who got multimodal analgesia, which consists of epidural anesthesia or peripheral nerve block

    Time frame: Given during intraoperative period

  4. Intraoperative fluid management

    Number of patients who achieved fluid balance of zero or near zero

    Time frame: Given during intraoperative period

  5. Postoperative pain management

    Number of patients who received postoperative pain management without opioid

    Time frame: Immediately after surgery until discharge, assessed until hospital discharge, up to 50 days

07

Study locations

1 site
  • Cipto Mangunkusumo Central National Hospital
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06065696
Lead sponsor
Indonesia University
Responsible party
Aldy Heriwardito (Principal Investigator, Indonesia University) — Principal investigator
First posted
Oct 4, 2023
Start date
Feb 1, 2023
Primary completion
Apr 30, 2023
Completion
Apr 30, 2023
Last update
Oct 4, 2023

Study contacts

Aldy Heriwardito, Consultant
principal investigator · Indonesia University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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