Enhanced Recovery After Surgery Protocol on Early Mobilization After Colorectal Surgery

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT06065696
Collaborator
(none)
343
1
2.9
118.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Early mobilization
  • Procedure: No 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

Study Type:
Observational
Actual Enrollment :
343 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Compliance With Enhanced Recovery After Surgery Protocol on Early Mobilization After Colorectal Surgery in Tertiary Hospital in Indonesia
Actual Study Start Date :
Feb 1, 2023
Actual Primary Completion Date :
Apr 30, 2023
Actual Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Early mobilization

Patients who achieved early mobilization after colorectal surgery

Procedure: Early mobilization
Patients who received early mobilization in postoperative period

No early mobilization

Patients who did not achieve early mobilization after colorectal surgery

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

Outcome Measures

Primary Outcome Measures

  1. Early mobilization [Within 24 hours after surgery]

    Number of patients who can walk within 24 hours after surgery

  2. PONV prophylaxis [Given during intraoperative period]

    Number of patients who received prophylaxis given for PONV

  3. Multimodal analgesia [Given during intraoperative period]

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

  4. Intraoperative fluid management [Given during intraoperative period]

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

  5. Postoperative pain management [Immediately after surgery until discharge, assessed until hospital discharge, up to 50 days]

    Number of patients who received postoperative pain management without opioid

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cipto Mangunkusumo Central National Hospital Jakarta Pusat DKI Jakarta Indonesia 10430

Sponsors and Collaborators

  • Indonesia University

Investigators

  • Principal Investigator: Aldy Heriwardito, Consultant, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aldy Heriwardito, Principal Investigator, Indonesia University
ClinicalTrials.gov Identifier:
NCT06065696
Other Study ID Numbers:
  • IndonesiaUAnes112
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aldy Heriwardito, Principal Investigator, Indonesia University

Study Results

No Results Posted as of Oct 4, 2023