An interventional study of Comprehensive 20-Item Pediatric ERAS Protocol in Appendectomy, Laparoscopic, Acute Appendicitis and Pediatric Surgery, sponsored by Ahmet Burak Doğan, MD. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Ahmet Burak Doğan, MD · Not applicable, Interventional, and Health services research
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.
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:
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:
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.
Protocol Amendments (August 2026). Following the first audit-and-feedback cycle (patients 1-20), two standard-of-care changes were implemented effective from patient 21 onward: (1) surgical antibiotic prophylaxis was changed from single-agent cefazolin (fixed 1 g dose) to the institutional directive-compliant regimen of weight-based cefazolin (30 mg/kg) plus metronidazole (15 mg/kg) for non-perforated appendectomy, adding anaerobic coverage (effective 5 August 2026); (2) the routine discharge analgesia prescription was simplified from the alternating paracetamol/ibuprofen regimen to paracetamol only, with ibuprofen reserved for exceptional cases (effective 13 August 2026). Surgical site infection and safety outcomes will be reported stratified by these two periods. In addition, documentation of the in-hospital scheduled oral analgesia was extended to cover scheduled doses through postoperative hour 21 (paracetamol only after hour 18), formalizing existing practice (documentation change only).
Protocol Amendments (September-October 2026). (1) Antibiotic prophylaxis timing (protocol item 6): based on the WHO-commissioned systematic review (de Jonge et al., 2017) and the Weber et al. (2017) randomized trial, the compliance window was widened from 60 to 120 minutes before incision without a tolerance margin, and the two agents are now administered separately: metronidazole 15 mg/kg as a 30-minute infusion on the ward when the patient is called to theatre, and cefazolin 30 mg/kg as a 3-5 minute IV push at induction by the anesthesia team. Effective from patient 42 (surgery on 15 September 2026). Item 6 compliance will be reported under both the original 60-minute and the revised 120-minute definitions, and separately for patients before and after the change. (2) Documentation of institutional intraoperative analgesia: from the first patient, the anesthesia team's standard practice has included IV paracetamol 15 mg/kg at induction; this pre-existing practice (dose, timing and diluent volume) is now recorded in the protocol and case report form (documentation change only; no change in care). (3) Fluid measurement definition (protocol version 1.9, 8 October 2026, superseding the crystalloid-only definition of 10 September 2026): intraoperative crystalloid and drug-diluent volumes are recorded separately, and item 11 (3-7 mL/kg/h) is scored on total intraoperative IV fluid, i.e. crystalloid plus the cefazolin diluent and the IV paracetamol solution. Existing scores, which were based on recorded total volumes, are unchanged; the crystalloid-only rate is reported as a sensitivity analysis. (4) Oral analgesia sequence and discharge dose (protocol version 1.6, 17 September 2026): to keep the day-of-surgery paracetamol total within the labelled maximum (60 mg/kg/day, 4 doses) once the induction IV dose is counted, the scheduled oral zigzag now starts with ibuprofen (hours 3, 9, 15, 21) and alternates with paracetamol (hours 6, 12, 18); after hour 21 and at discharge only weight-based paracetamol (15 mg/kg per dose, three times daily) is given, and ibuprofen is not prescribed at home. Effective from patient 41 (surgery on 8 September 2026). Item 19 compliance is scored independently of the sequence; discharge dose (mg/kg) is reported separately for the two periods.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 100 is close to the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Ahmet Burak Doğan, MD is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children aged 5-18 with non-complicated acute appendicitis (ASA I-II) undergoing elective minimally invasive (laparoscopic) appendectomy who receive the comprehensive 20-item perioperative ERAS protocol as the institutional standard of care during the pilot period. The arm is single; there is no concurrent control group. Comparison anchors are pre-specified literature thresholds (≥70% compliance lower bound) and historical descriptive baseline data from the preceding 6 months at the same institution.
Other: Comprehensive 20-Item Pediatric ERAS Protocol
20-item multidisciplinary pathway. Preoperative (5): family education; clear fluids up to 2 h; no carbohydrate loading; no bowel preparation; restricted premedication. Intraoperative (9): prophylactic antibiotics within 120 min before incision (60 min until patient 41; agents given separately from patient 42); institutional IV paracetamol 15 mg/kg at induction; bupivacaine port-site infiltration; short-acting anesthetics; opioid \<0.1 mg/kg morphine equivalent; normothermia \>36 C; total IV fluid 3-7 mL/kg/h (incl. drug diluents); minimally invasive approach; no routine drains/tubes; PONV prophylaxis (ondansetron+dexamethasone). Postoperative (6): early NG tube removal; oral feeding within 2-4 h; early IV discontinuation; mobilization (corridor by hour 6); zigzag oral analgesia q3h to hour 21 (ibuprofen 10 mg/kg alternating with paracetamol 15 mg/kg; ibuprofen first from patient 41); criterion-based discharge; paracetamol-only discharge Rx (15 mg/kg/dose from patient 41).
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).
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.
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 days
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).
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 days
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 day
Time to First Oral Tolerance (Water)
Time from end of surgery (T0) to successful oral water tolerance in hours.
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 from end of surgery (T0) to first unsupported ambulation in hours.
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 from end of surgery (T0) to first tolerated age-appropriate normal diet (≥150 mL or age-appropriate portion) in hours.
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)
Total rescue opioid consumption between hour 0 and hour 24 postoperatively, normalized to milligram morphine equivalent dose (MED) per kilogram body weight (mg/kg).
Time frame: First 24 hours postoperative.
Parent-Reported Outcomes (PROMs) - Anxiety, Satisfaction, Quality of Recovery
Three components measured via the study-specific "ERAS Family Experience and Clinical Monitoring Form" administered before actual discharge: (a) parental preoperative anxiety on a 0-10 visual analog scale (VAS); (b) parental postoperative satisfaction on a 0-10 VAS (target ≥8/10); (c) attainment rates of categorical (Yes/No) quality-of-recovery items including information adequacy, early oral tolerance, mobilization adequacy, and oral analgesia pain control. Reported as median (IQR) for VAS and proportions with 95% CIs for categorical items.
Time frame: Pre-discharge (typically postoperative day 0-2).
Provider Knowledge-Attitudes-Practice (KAP) Change
Pre-pilot vs post-pilot KAP module score change among the multidisciplinary team (surgeons, anesthesiologists, OR/ward nurses). Wilcoxon signed-rank test if paired n ≥15; otherwise descriptive only.
Time frame: Pre-pilot (before patient enrollment) and post-pilot (after final patient enrollment), approximately 12 months apart.
CFIR Barriers Assessment
CFIR 2.0-informed barriers/facilitators perception scores among the multidisciplinary team, administered pre-pilot.
Time frame: Pre-pilot (before patient enrollment).
NoMAD Normalization Process Measure
NoMAD-TR (Turkish-validated) normalization measures of how the ERAS protocol becomes embedded in routine practice, administered post-pilot.
Time frame: Post-pilot (within 1 month of last patient discharge).
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.
Plan to share: Yes — De-identified individual participant data underlying the published results, the full study protocol, the statistical analysis plan, and the informed consent forms will be made available upon reasonable request following primary publication. Access will be granted to investigators with a methodologically sound proposal for individual participant data meta-analyses or hypothesis-confirming research. Requests will be reviewed by the principal investigator and the study steering committee. Data will be transferred via encrypted email or institutional secure repository following execution of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Beginning 6 months and ending 5 years following primary publication.
Access criteria: Investigators with a methodologically sound proposal for individual participant data meta-analyses or hypothesis-confirming research. Requests will be reviewed by the principal investigator and the study steering committee. Data will be transferred via encrypted email or institutional secure repository following execution of a data sharing agreement.
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Ahmet Burak Doğan, MD