Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy

Background and Rationale Acute appendicitis affects roughly 1 in 10 children in their lifetime and remains the leading cause of emergency abdominal surgery in pediatric populations. Although laparoscopic appendectomy has become the standard of care for non-complicated cases, perioperative practice patterns vary substantially. Routine prolonged preoperative fasting, opioid-based postoperative analgesia, delayed enteral feeding, and the prophylactic use of nasogastric tubes, abdominal drains, and urinary catheters persist in many institutions despite evidence to the contrary. This unwarranted clinical variation prolongs recovery, increases adverse events, and exposes children to avoidable opioid exposure.

Enhanced Recovery After Surgery (ERAS) protocols package multiple evidence-based perioperative interventions into a coordinated multidisciplinary care pathway. Adult ERAS programs have consistently demonstrated reductions in complications, length of stay, and resource utilization. Pediatric ERAS adoption has lagged but is accelerating, particularly in colorectal, urological, and now general surgical contexts. Most pediatric ERAS reports to date, however, focus on elective procedures - applying ERAS to a time-pressured, emergent context like acute appendicitis introduces operational challenges (limited preoperative optimization window, variable family preparation, fluctuating staffing) that must be tested locally before adoption.

Conceptual Framework This study follows the IDEAL Framework Stage 2a (Development) for surgical innovation: a structured, prospective evaluation of a defined protocol in a single center, with explicit revision logic and transparent reporting. Implementation science elements are integrated through (a) Knowledge-Attitudes-Practice (KAP) surveys before and after the pilot, (b) a CFIR 2.0-informed barriers assessment, and (c) NoMAD-based normalization process measures. The study is registered as interventional (single-group assignment, open-label; Health Services Research) because all enrolled patients are prospectively and uniformly exposed to the institutional ERAS protocol as a defined health-services intervention. There is no randomization and no experimental drug or device assignment; the protocol is applied to consecutive eligible patients.

The 20-Item ERAS Protocol

The protocol spans the perioperative pathway in three blocks:

Preoperative (5 items): ERAS counseling and family education; avoidance of prolonged fasting (clear fluids permitted up to 2 hours; solids ≥6 hours); no oral carbohydrate loading (acute appendicitis context); no mechanical bowel preparation; restricted sedative premedication.

Intraoperative (9 items): timely prophylactic antibiotics (within 30-60 min of incision); regional analgesia with 0.25% bupivacaine port-site infiltration; short-acting anesthetic agents; restricted intraoperative opioid (\<0.1 mg/kg morphine equivalent); active normothermia (core temp \>36 °C); goal-directed euvolemic fluid therapy (3-7 mL/kg/h crystalloid, zero balance target); minimally invasive surgical approach; avoidance of routine drains/tubes; universal PONV prophylaxis (ondansetron + dexamethasone 0.15 mg/kg, max 8 mg).

Postoperative (6 items): early NG tube removal; early oral feeding (clear fluids within 2-4 hours; staged advancement to age-appropriate diet); early IV fluid discontinuation (saline lock once 100 mL tolerated orally); early mobilization (out of bed by hour 4, corridor walk by hour 6); multimodal scheduled "zigzag" oral analgesia (paracetamol 15 mg/kg PO q6h alternating with ibuprofen 10 mg/kg PO q6h, every 3 hours); criterion-based discharge planning.

Decision Algorithms

Three algorithms standardize bedside decisions:

* PONV cascade (3 levels: nausea → 30-min pause; first emesis → rescue antiemetic from a different receptor class with 1-hour wait then re-challenge from clear fluids; clinically significant emesis → suspend ERAS feeding goals, restart IV maintenance, surgical reassessment for ileus/mechanical/leak); * Rescue analgesia (triggered by VAS ≥5 in patients ≥7 years or FLACC ≥5 in \<7 years on two consecutive measurements 30 minutes apart, despite scheduled paracetamol+ibuprofen; managed with low-dose IV opioid recorded as rescue, not as a protocol deviation); * Medical Readiness for Discharge (MRD): a six-criterion checklist (tolerating ≥Phase 2 diet without vomiting; oral analgesia adequate VAS/FLACC \<4; age-appropriate ambulation; spontaneous urine output; family preparedness; physiologic stability with SpO2 \>95% on room air, temperature \<38 °C in last 4 hours, vital signs within PALS limits). Notably, gas/stool passage is explicitly NOT an MRD criterion. After MRD, patients enter a brief "in-hospital home simulation" phase before actual discharge to measure the institutional/cultural delay (Δ time = T-discharge - T-MRD).

Run-in Phase and Decision Gate

Per IDEAL Stage 2a methodology, the first 5 enrolled patients constitute a Run-in (Vanguard) phase. After the 5th patient, the leadership team conducts an Early Safety and Compliance Audit:

* Decision A (Protocol Stable): if ≥70% compliance and no Clavien-Dindo ≥III complications, the patients are included in the main analysis and enrollment continues. * Decision B (Protocol Revision): if a systemic implementability barrier is identified, the first 5 patients are excluded from primary feasibility analysis, the protocol is revised to Version 2.0, ethics committee notification/approval is obtained, and the screening target is increased to N=105 to preserve statistical power. A pre-specified sensitivity analysis includes the original 5 patients in an "all-enrolled" set for transparency.

Audit and Feedback Compliance scorecard data are reviewed every 20 patients (h20, h40, h60, h80) by the leadership team. Compliance items are dichotomously coded (1=achieved, 0=not). Up to 3 items may be voided due to medical contraindication; ≥4 voided items classify the patient as "complex" and exclude them from the primary compliance analysis. Rescue analgesia use does NOT affect compliance scoring of the multimodal oral analgesia item but is reported as a secondary metric (total opioid consumption in mg/kg morphine equivalents).

Stopping Rules (3-tier) Level 1 (Immediate report): Any Clavien-Dindo ≥III complication is reported to the IRB within 24 hours as a Serious Adverse Event.

Level 2 (Temporary halt): Triggered by (a) any Grade IV/V complication, OR (b) cumulative Clavien-Dindo ≥III rate exceeding 10% in any consecutive 10-patient window, OR (c) unplanned true readmission rate exceeding 10% in any consecutive 10-patient window. Enrollment pauses; the leadership team holds an emergency safety meeting with at least one independent senior clinician (department chair or hospital quality/safety representative) as observer.

Level 3 (Permanent halt): If post-pause review concludes the complications are protocol-attributable, the study is permanently terminated and the IRB is notified with a detailed report.

Mixed Methods and Implementation Science The study uses a Concurrent Embedded mixed-methods design. Quantitative implementation outcomes (compliance, MRD time, length of stay, complications, opioid use) are integrated with provider surveys (KAP pre/post, CFIR Barriers, NoMAD post-pilot) and parent-reported outcomes (study-specific PROMs CRF: VAS for parental anxiety/satisfaction, categorical Yes/No items for quality of recovery). Qualitative content analysis of an open-ended PROMs question uses two-coder blinded review with Cohen's κ ≥0.70 threshold and third-coder consensus arbitration.

Statistical Analysis Sample size: precision-based, single-proportion formula yields n=80 evaluable patients to estimate compliance at 80% with a 95% CI half-width of ±8.7% (lower bound 71.3%, upper 88.7%) - verified in G\*Power 3.1 ('Proportion: Confidence Interval Width' module). Allowing for \~20% cumulative attrition (10-15% intraoperative reclassification, 2-5% laparoscopic-to-open conversion, 3-5% follow-up loss), 100 patients are enrolled.

The primary endpoint compliance rate is reported as a point estimate with Wilson 95% CI. Co-primary safety endpoints (Clavien-Dindo ≥III, 30-day readmission) are similarly reported. Critical-item compliance is reported per item with 95% CIs. Survey modules: KAP pre vs post - Wilcoxon signed-rank if paired n ≥15, otherwise descriptive only; KAP/CFIR Cronbach α ≥0.70 threshold reported (gating); NoMAD α reported but non-gating. Subgroup analyses are exploratory/hypothesis-generating. Missing data: pre-specified multiple imputation thresholds. Reporting follows CONSORT-Pilot.

Anticipated Outcomes If feasibility is demonstrated (compliance ≥80% with CI lower bound \>70%, safety endpoints below 5%), the protocol will be formalized as the institutional standard for non-complicated pediatric appendectomy and will inform a planned multi-center IDEAL Stage 3 trial. If feasibility is not demonstrated, the audit data will identify specific implementability barriers for targeted revision before any further deployment.

• Critical-Item Compliance Rate [Time frame: From surgery (Day 0) through hospital discharge, an average of 2 days]
• Time to Medical Readiness for Discharge (MRD) [Time frame: From PACU arrival until MRD criteria met (typically ≤48 hours).]
• Actual Length of Hospital Stay [Time frame: From end of surgery to actual hospital discharge, an average of 2 days]
• Delta Time (Institutional Discharge Delay Metric) [Time frame: From objective medical readiness (T-MRD) to actual hospital discharge, an average of 1 day]
• Time to First Oral Tolerance (Water) [Time frame: From end of surgery (Day 0) to first successful oral water tolerance, an average of 4 hours]
• Time to First Unsupported Ambulation [Time frame: From end of surgery (Day 0) to first unsupported ambulation, an average of 8 hours]
• Time to First Age-Appropriate Normal Diet (Phase 3) [Time frame: From end of surgery (Day 0) to first tolerated age-appropriate normal diet, an average of 24 hours.]
• Total Rescue Opioid Consumption (0-24 hours) [Time frame: First 24 hours postoperative.]
• Parent-Reported Outcomes (PROMs) - Anxiety, Satisfaction, Quality of Recovery [Time frame: Pre-discharge (typically postoperative day 0-2).]
• Provider Knowledge-Attitudes-Practice (KAP) Change [Time frame: Pre-pilot (before patient enrollment) and post-pilot (after final patient enrollment), approximately 12 months apart.]
• CFIR Barriers Assessment [Time frame: Pre-pilot (before patient enrollment).]
• NoMAD Normalization Process Measure [Time frame: Post-pilot (within 1 month of last patient discharge).]