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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06065696
Other study ID # IndonesiaUAnes112
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date April 30, 2023

Study information

Verified date September 2023
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 343
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Procedure:
Early mobilization
Patients who received early mobilization in postoperative period
No early mobilization
Patients who did not receive early mobilization in postoperative period

Locations

Country Name City State
Indonesia Cipto Mangunkusumo Central National Hospital Jakarta Pusat DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early mobilization Number of patients who can walk within 24 hours after surgery Within 24 hours after surgery
Primary PONV prophylaxis Number of patients who received prophylaxis given for PONV Given during intraoperative period
Primary Multimodal analgesia Number of patients who got multimodal analgesia, which consists of epidural anesthesia or peripheral nerve block Given during intraoperative period
Primary Intraoperative fluid management Number of patients who achieved fluid balance of zero or near zero Given during intraoperative period
Primary 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
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