Clinical trial NCT06981572: Comparing the Effectiveness of Modified ERAS Protocols vs. Standard Management in Pediatric Gastrointestinal Surgery
Official title: Comparison of the Effectiveness of Implementing Modified ERAS Protocols vs. Standard Management in Pediatric Patients Undergoing Major Gastrointestinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Anesthesia
Keywords: enhanced recovery after surgery
major intestinal surgery
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-05-20
Enrollment: 82
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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. ERAS was first introduced by a Danish surgeon, Henrik Kehlet in the 1990s to reduce perioperative stress and organ dysfunction in surgical patients. ERAS is an evidence-based technique and combines and optimizes various multidisciplinary methods used in conventional surgical management, includes surgery, anesthesia, nursing, and nutrition. ERAS emphasizes perioperative preparation including preoperative counseling, limited time in preoperative fasting, optimal anesthesia, minimally invasive techniques, immediate postoperative oral nutrition and mobilization, and non-routine use of drainage and surgical tubes. 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 because several conditions are not possible in pediatric patients, for example, administering anticoagulants, post-operative fasting, etc., thus requiring modifications that are tailored to the characteristics of the patients at Ciptomangunkusumo Hospital. Children experience a more complex surgical stress response than adult patients. Conventional perioperative management in children often results in greater physical stress. Therefore, perioperative management in children needs to be optimized.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Length of stay
timeFrame: The timeframe is calculated from when the patient undergoes preoperative assessment until discharge from the hospital, up to 3 months.
Secondary outcomes:
measure: Blood glucose level (mg/dL)
timeFrame: The time frame includes 1 day before surgery (preoperative), during surgery (intraoperative), and on the 3rd and 5th days after surgery (postoperative)
measure: Blood electrolyte levels (Na, K, Cl)
timeFrame: Blood electrolyte levels assessed 1 day before surgery (preoperative) and on the 3rd day after surgery (postoperative)
measure: Oral Nutrition Initiation Time
timeFrame: 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
measure: Time to mobilization
timeFrame: 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
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Central National Hospital
Study officials:
affiliation: Anesthesiology and Intensive Therapy Departement
name: Andi Ade Wijaya Ramlan
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.