Comparing the Effectiveness of Modified ERAS Protocols vs. Standard Management in Pediatric Gastrointestinal Surgery

NCT06981572 | Completed DMC

• 1 other identifier: IndonesiaUAnes2809
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Perioperative management of pediatric patients with gastrointestinal diseases involves a fairly length process and which can lead to rapid deterioration even death. Preoperative management includes preoperative fasting for such a long time, usage of drains and tubes and post-operative bed rest for a long time which can cause pain, stress, and slowing down the recovery time for normal bowel function, thus further prolonging the patient's stay in hospital. Enhanced recovery after surgery (ERAS) is a concept that seeks faster recovery times for pediatric patients and shortens the length of hospital stay while still improving postoperative outcomes. The ERAS modification protocol aims to optimize inpatient care and minimize patient discomfort. Studies show that implementing the modified ERAS protocol can reduce the duration of hospitalization and the incidence of postoperative complications as well as speedy recovery. However, currently the standard ERAS protocol is difficult to apply to pediatric patients. This study will determine the comparison of the effectiveness of the ERAS modification protocol with the standard protocol in reducing length of stay and improving postoperative outcomes for pediatric patients at RSCM who underwent major gastrointestinal surgery using the ERAS modification method.

Conditions

Surgery; Anesthesia

Keywords

enhanced recovery after surgery; major intestinal surgery

Outcome Measures

Primary Outcomes (1)

• Length of stay

  Patients' length of stay in the hospital, measured in days

  The timeframe is calculated from when the patient undergoes preoperative assessment until discharge from the hospital, up to 3 months.

Secondary Outcomes (4)

• Blood glucose level (mg/dL)

  The time frame includes 1 day before surgery (preoperative), during surgery (intraoperative), and on the 3rd and 5th days after surgery (postoperative)

• Blood electrolyte levels (Na, K, Cl)

  Blood electrolyte levels assessed 1 day before surgery (preoperative) and on the 3rd day after surgery (postoperative)

• Oral Nutrition Initiation Time

  The time frame is calculated from the end of the surgery and will be evaluated up to the time of the patient's discharge from the hospital

• Time to mobilization

  The time frame is calculated from the end of surgery and will be evaluated up to the time of the patient's discharge from the hospital

Study Arms (2)

modified ERAS protocol applied

ACTIVE COMPARATOR

patients modified ERAS protocol applied

Procedure: Modified Enhanced Recovery After Surgery Protocol

standart protocol applied

NO INTERVENTION

patients with standart protocol applied

Interventions

Modified Enhanced Recovery After Surgery Protocol PROCEDURE

This study is to determine the comparison of the effectiveness of the ERAS modification protocol with the standard protocol in reducing length of stay and improving postoperative outcomes for pediatric patients at RSCM who underwent major gastrointestinal surgery using the ERAS modification method. This study is a single-blind clinical trial. Research subjects will be randomly divided into two groups, namely the group who underwent surgery with the ERAS modification protocol and the group who underwent surgery without the ERAS modification protocol. Modified ERAS protocol will be applied during perioperative

modified ERAS protocol applied

Eligibility Criteria

• Age: 1 Month - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged 1 month to 2 years
• The patient underwent major gastrointestinal surgery
• ASA 1 and 2 physical status
• The patient will undergo elective lower abdominal surgery with general and regional anesthesia

You may not qualify if:

• Patients with cyanotic congenital heart defects
• Patients with metabolic disorders
• Patients with decreased consciousness
• Patients with severe cognitive impairment
• Patients with relaparotomy due to surgical complications

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, Indonesia

Location

Related Publications (12)

• Brindle ME, Heiss K, Scott MJ, Herndon CA, Ljungqvist O, Koyle MA; on behalf Pediatric ERAS (Enhanced Recovery After Surgery) Society. Embracing change: the era for pediatric ERAS is here. Pediatr Surg Int. 2019 Jun;35(6):631-634. doi: 10.1007/s00383-019-04476-3. Epub 2019 Apr 25.

  PMID: 31025092 BACKGROUND

• Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures: An Updated Report by the American Society of Anesthesiologists Task Force on Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration. Anesthesiology. 2017 Mar;126(3):376-393. doi: 10.1097/ALN.0000000000001452. No abstract available.

  PMID: 28045707 BACKGROUND

• Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1.

  PMID: 21712716 BACKGROUND

• Garin C. Enhanced recovery after surgery in pediatric orthopedics (ERAS-PO). Orthop Traumatol Surg Res. 2020 Feb;106(1S):S101-S107. doi: 10.1016/j.otsr.2019.05.012. Epub 2019 Sep 12.

  PMID: 31522902 BACKGROUND

• Ceelie I, de Wildt SN, van Dijk M, van den Berg MM, van den Bosch GE, Duivenvoorden HJ, de Leeuw TG, Mathot R, Knibbe CA, Tibboel D. Effect of intravenous paracetamol on postoperative morphine requirements in neonates and infants undergoing major noncardiac surgery: a randomized controlled trial. JAMA. 2013 Jan 9;309(2):149-54. doi: 10.1001/jama.2012.148050.

  PMID: 23299606 BACKGROUND

• Carli F. Physiologic considerations of Enhanced Recovery After Surgery (ERAS) programs: implications of the stress response. Can J Anaesth. 2015 Feb;62(2):110-9. doi: 10.1007/s12630-014-0264-0. Epub 2014 Dec 12.

  PMID: 25501695 BACKGROUND

• Somri M, Matter I, Parisinos CA, Shaoul R, Mogilner JG, Bader D, Asphandiarov E, Gaitini LA. The effect of combined spinal-epidural anesthesia versus general anesthesia on the recovery time of intestinal function in young infants undergoing intestinal surgery: a randomized, prospective, controlled trial. J Clin Anesth. 2012 Sep;24(6):439-45. doi: 10.1016/j.jclinane.2012.02.004. Epub 2012 Jul 2.

  PMID: 22762977 BACKGROUND

• Narvey MR, Marks SD. The screening and management of newborns at risk for low blood glucose. Paediatr Child Health. 2019 Dec;24(8):536-554. doi: 10.1093/pch/pxz134. Epub 2019 Dec 9.

  PMID: 31844395 BACKGROUND

• Gao R, Yang H, Li Y, Meng L, Li Y, Sun B, Zhang G, Yue M, Guo F. Enhanced recovery after surgery in pediatric gastrointestinal surgery. J Int Med Res. 2019 Oct;47(10):4815-4826. doi: 10.1177/0300060519865350. Epub 2019 Aug 4.

  PMID: 31379230 BACKGROUND

• George JA, Salazar AJG, Irfan A, Prichett L, Nasr IW, Garcia AV, Boss EF, Jelin EB. Effect of implementing an enhanced recovery protocol for pediatric colorectal surgery on complication rate, length of stay, and opioid use in children. J Pediatr Surg. 2022 Jul;57(7):1349-1353. doi: 10.1016/j.jpedsurg.2022.01.004. Epub 2022 Jan 15.

  PMID: 35153077 BACKGROUND

• Phillips MR, Adamson WT, McLean SE, Hance L, Lupa MC, Pittenger SL, Dave P, McNaull PP. Implementation of a pediatric enhanced recovery pathway decreases opioid utilization and shortens time to full feeding. J Pediatr Surg. 2020 Jan;55(1):101-105. doi: 10.1016/j.jpedsurg.2019.09.065. Epub 2019 Nov 15.

  PMID: 31784102 BACKGROUND

• Loganathan AK, Joselyn AS, Babu M, Jehangir S. Implementation and outcomes of enhanced recovery protocols in pediatric surgery: a systematic review and meta-analysis. Pediatr Surg Int. 2022 Jan;38(1):157-168. doi: 10.1007/s00383-021-05008-8. Epub 2021 Sep 15.

  PMID: 34524519 BACKGROUND

Study Officials

• Andi Ade Wijaya Ramlan

  Anesthesiology and Intensive Therapy Departement

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Anesthesiology and Intensive Therapy

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: May 20, 2025
• Study Start: March 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)