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

NCT ID: NCT06981572

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-03-31

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.

Conditions

Surgery; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

modified ERAS protocol applied

patients modified ERAS protocol applied

Group Type: ACTIVE_COMPARATOR

Modified Enhanced Recovery After Surgery Protocol

Intervention Type: 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

standart protocol applied

patients with standart protocol applied

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Modified Enhanced Recovery After Surgery Protocol

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Andi Ade Wijaya Ramlan

Head of Department of Anesthesiology and Intensive Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andi Ade Wijaya Ramlan

Role: STUDY_CHAIR

Anesthesiology and Intensive Therapy Departement

Locations

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, , Indonesia

Countries

Indonesia

References

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Reference Type: BACKGROUND

PMID: 31025092 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 28045707 (View on PubMed)

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Other Identifiers

IndonesiaUAnes2809

Identifier Type: -

Identifier Source: org_study_id