CompletedNot Applicable

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

Indonesia82 participantsStarted 2024-03-01

Plain-language 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.

Who can participate

Age range

1 Month – 2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Length of stay

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

Trial details

NCT IDNCT06981572

SponsorIndonesia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

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