Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorAhmet Burak Doğan, MD
About this trial
Acute appendicitis is the most common surgical emergency in children. Despite the widespread adoption of laparoscopic appendectomy, postoperative care still varies widely between institutions, with prolonged fasting, opioid-based analgesia, delayed feeding, and routine drain placement being common. Enhanced Recovery After Surgery (ERAS) is an evidence-based, multidisciplinary care pathway that has been shown in adults - and increasingly in children - to reduce length of stay, opioid consumption, and postoperative complications.
This single-center, prospective, single-arm cohort feasibility study (IDEAL Stage 2a) tests whether a comprehensive 20-item pediatric ERAS protocol, adapted for minimally invasive appendectomy in children aged 5-18 with non-complicated acute appendicitis (ASA I-II), can be implemented with high fidelity and acceptable safety in a tertiary academic pediatric surgery department. We aim to enroll 100 patients to obtain \~80 evaluable cases. The primary endpoint is the global ERAS compliance rate (target ≥80%, with the lower bound of the 95% confidence interval staying above 70%). Co-primary safety endpoints include Clavien-Dindo ≥III complications and 30-day unplanned readmission rates, both targeted at \<5%. Secondary endpoints include time to medical readiness for discharge, actual length of stay, opioid sparing, and parent-reported outcomes.
The study includes a structured run-in phase (first 5 patients) with explicit decision logic to either continue with the protocol unchanged or revise it before full enrollment. Audit-and-feedback cycles every 20 patients monitor compliance drift. The findings will inform a definitive institutional clinical guideline and provide hypothesis-generating data for future multi-center trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patients aged 5 to 18 years (preschool, school-age, and adolescent).
Acute appendicitis without preoperative radiologic or clinical evidence of complication/perforation, who are candidates for and accept laparoscopic surgery.
ASA Physical Status I (healthy) or ASA II (mild systemic disease).
Family/legal guardians literate in Turkish (or the institution's primary service language) and able to comprehend the educational materials.
Disqualifiers
Preoperative imaging or clinical evidence of complicated appendicitis (perforation, generalized peritonitis, intra-abdominal abscess) anticipated to require an extended procedure (anastomosis, resection, or extensive peritoneal irrigation).
History of chronic pain syndrome or regular/sustained opioid use within the past 3 months.
Therapeutic preoperative antibiotic treatment for an active infection (other than surgical prophylaxis).
ASA III or higher; immunosuppression, progressive neurological disease, chronic inflammatory bowel disease, or other significant comorbidities likely to interfere with postoperative recovery/mobilization.
Trial design
Design model
Single group
Treatments tested in this trial
Comprehensive 20-Item Pediatric ERAS Protocol
Other interventionA multidisciplinary 20-item perioperative pathway. Preoperative (5 items): family education; clear fluids up to 2 h preoperatively; no carbohydrate loading; no bowel preparation; restricted sedative premedication. Intraoperative (9 items): prophylactic antibiotics within 30-60 min of incision; 0.25% bupivacaine port-site infiltration; short-acting anesthetics; intraoperative opioid \<0.1 mg/kg morphine equivalent; active normothermia \>36 C; goal-directed fluid therapy 3-7 mL/kg/h; minimally invasive approach; no routine drains/tubes; PONV prophylaxis (ondansetron + dexamethasone). Postoperative (6 items): early NG tube removal; early oral feeding within 2-4 h; early IV fluid discontinuation; early mobilization (corridor walk by hour 6); scheduled multimodal zigzag oral analgesia (paracetamol 15 mg/kg alternating with ibuprofen 10 mg/kg, scheduled doses through postoperative hour 21); criterion-based discharge planning; paracetamol-only discharge prescription (from patient 21 onward).
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: ERAS Protocol Implementation CohortExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Global ERAS Compliance Rate
Proportion of patients in the evaluable cohort (n≈80) achieving full compliance with at least 80% of the applicable 20 ERAS items (i.e., at least 16 of 20 items implemented as planned). Each of the 20 items is dichotomously coded (1 = achieved, 0 = not achieved). Up to 3 items may be voided per patient due to medical contraindication; patients with ≥4 voided items are classified as "complex" and excluded from the primary analysis. The compliance rate is reported as a point estimate with Wilson 95% confidence interval. The pre-specified success criterion is the lower bound of the 95% CI exceeding 70%.
Time frame
Index hospitalization, from preoperative admission through actual discharge (typically ≤72 hours).2
Postoperative Major Complication and Unplanned Readmission Rate (30-day)(Co-primary)
Composite of (a) Clavien-Dindo Grade III or higher major complications occurring within 30 days of surgery, AND (b) unplanned true inpatient readmission within 30 days of discharge. Each component is reported separately as a proportion with 95% CI. The pre-specified success criterion is each component remaining below 5%. Both feasibility (Primary Outcome 1) and this safety composite must be met for the protocol to be considered feasible-and-safe.
Time frame
30 days postoperative.Secondary outcomes
1
Critical-Item Compliance Rate
Per-item compliance rate for each of 5 critical ERAS components: (i) multimodal analgesia, (ii) goal-directed perioperative fluid management, (iii) early oral feeding, (iv) minimally invasive surgical approach, (v) drain/tube restriction. Reported as proportions with 95% CIs. Each is targeted at \>80%.
Time frame
From surgery (Day 0) through hospital discharge, an average of 2 days2
Time to Medical Readiness for Discharge (MRD)
Time from arrival at the post-anesthesia care unit (T0) to the time the patient meets all 6 MRD criteria, reported in hours. MRD criteria are: (i) tolerating at least Phase 2 diet without vomiting and without IV support (no vomiting in last 4 hours); (ii) pain controlled on oral analgesics alone with VAS or FLACC \<4; (iii) age-appropriate unsupported ambulation; (iv) spontaneous urine output; (v) family preparedness for home care; (vi) physiologic stability and normothermia (room-air SpO2 \>95% or baseline; temperature \<38 °C in the last 4 hours; heart rate, blood pressure, respiratory rate within PALS 2020 limits ±10%).
Time frame
From PACU arrival until MRD criteria met (typically ≤48 hours).3
Actual Length of Hospital Stay
Time in hours from end of surgery to actual hospital discharge.
Time frame
From end of surgery to actual hospital discharge, an average of 2 days4
Delta Time (Institutional Discharge Delay Metric)
T-Discharge minus T-MRD, in hours - measures the institutional/cultural delay between objective medical readiness and actual discharge.
Time frame
From objective medical readiness (T-MRD) to actual hospital discharge, an average of 1 dayOther outcomes
1
Compliance-Outcome Correlation (hypothesis-generating)
Spearman rank correlation between individual ERAS Compliance Score and (a) MRD time, (b) total rescue opioid use, (c) actual LOS. Reported as point estimate with 95% CI; pre-specified as exploratory/hypothesis-generating given the limited sample size.
Time frame
Cumulative across 30-day follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ahmet Burak Doğan, MD
Lead sponsor
TC Erciyes University
Sponsor institution
Source ClinicalTrials.gov