NCT06065696

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
343

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
Last Updated

October 4, 2023

Status Verified

September 1, 2023

Enrollment Period

3 months

First QC Date

July 31, 2023

Last Update Submit

September 30, 2023

Conditions

Enhanced Recovery After SurgeryAnesthesiaSurgery-ComplicationsColorectalEarly Mobilization

Keywords

early mobilizationEnhanced Recovery After SurgeryPONV prophylaxisfluid managementpain management

Outcome Measures

Primary Outcomes (5)

  • Early mobilization

    Number of patients who can walk within 24 hours after surgery

    Within 24 hours after surgery

  • PONV prophylaxis

    Number of patients who received prophylaxis given for PONV

    Given during intraoperative period

  • Multimodal analgesia

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

    Given during intraoperative period

  • Intraoperative fluid management

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

    Given during intraoperative period

  • Postoperative pain management

    Number of patients who received postoperative pain management without opioid

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

Study Arms (2)

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

Early mobilizationPROCEDURE

Patients who received early mobilization in postoperative period

Early mobilization
No early mobilizationPROCEDURE

Patients who did not receive early mobilization in postoperative period

No early mobilization

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Agnosia

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Aldy Heriwardito, Consultant

    Indonesia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 31, 2023

First Posted

October 4, 2023

Study Start

February 1, 2023

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

October 4, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)