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

Not Applicable

Completed

• Conditions: Surgery; Anesthesia

• Registration Number: NCT06981572
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2024-03-01
• Study First Submitted: 2024-03-28
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Length of stay	The timeframe is calculated from when the patient undergoes preoperative assessment until discharge from the hospital, up to 3 months.	Patients' length of stay in the hospital, measured in days

Secondary Outcome Measures

Name	Time	Method
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 glucose levels measured and compared during the preoperative, intraoperative, and postoperative periods
Blood electrolyte levels (Na, K, Cl)	Blood electrolyte levels assessed 1 day before surgery (preoperative) and on the 3rd day after surgery (postoperative)	Blood electrolyte levels assessed during the preoperative and postoperative periods
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	The time when the patient begins receiving oral nutrition, starting with clear fluids. Oral nutrition initiation time will be measured in hours
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	The time when the patient begins mobilization, which includes turning to the right and left sides, sitting, walking, and eventually resuming preoperative activities without pain or discomfort. The mobilization time is measured in days

Trial Locations

Locations (1)

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Jakarta Pusat, Indonesia