Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy

NCT07643285 | Not Yet Recruiting

• 1 other identifier: ERU-PEDERAS-2026-263
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Appendectomy, Laparoscopic; Acute Appendicitis; Pediatric Surgery; ERAS

Outcome Measures

Primary Outcomes (2)

• 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%.

  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.

  30 days postoperative.

Secondary Outcomes (12)

• Critical-Item Compliance Rate

  From surgery (Day 0) through hospital discharge, an average of 2 days

• Time to Medical Readiness for Discharge (MRD)

  From PACU arrival until MRD criteria met (typically ≤48 hours).

• Actual Length of Hospital Stay

  From end of surgery to actual hospital discharge, an average of 2 days

• Delta Time (Institutional Discharge Delay Metric)

  From objective medical readiness (T-MRD) to actual hospital discharge, an average of 1 day

• Time to First Oral Tolerance (Water)

  From end of surgery (Day 0) to first successful oral water tolerance, an average of 4 hours

Other Outcomes (1)

• Compliance-Outcome Correlation (hypothesis-generating)

  Cumulative across 30-day follow-up.

Study Arms (1)

ERAS Protocol Implementation Cohort

EXPERIMENTAL

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

Interventions

Comprehensive 20-Item Pediatric ERAS Protocol OTHER

A multidisciplinary 20-item perioperative care pathway spanning preoperative (5 items: family education, fasting management with clear fluids permitted up to 2 hours preoperatively, no oral carbohydrate loading, 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 \>36 °C, goal-directed euvolemic fluid therapy 3-7 mL/kg/h, minimally invasive surgical approach, avoidance of routine drains/tubes, universal PONV prophylaxis with ondansetron + dexamethasone 0.15 mg/kg max 8 mg), and postoperative (6 items: early NG tube removal, early oral feeding within 2-4 hours, early IV fluid discontinuation, early mobilization with corridor walk by hour 6, multimodal scheduled zigzag oral analgesia with paracetamol 15 mg/

ERAS Protocol Implementation Cohort

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Written informed consent from parents/legal guardians; for children of sufficient developmental maturity (generally ≥7 years), age-appropriate written assent.

You may not qualify if:

• 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.
• Anatomic/mechanical contraindications to laparoscopy or pneumoperitoneum (e.g., prior major open abdominal surgery with suspected adhesions, abdominal wall defects).

Sponsors & Collaborators

• Ahmet Burak Doğan, MD: lead

Study Sites (1)

Erciyes University Faculty of Medicine, Department of Pediatric Surgery

Kayseri, Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (7)

• Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.

  PMID: 27777223 BACKGROUND

• Finch TL, Girling M, May CR, Mair FS, Murray E, Treweek S, McColl E, Steen IN, Cook C, Vernazza CR, Mackintosh N, Sharma S, Barbery G, Steele J, Rapley T. Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT). BMC Med Res Methodol. 2018 Nov 15;18(1):135. doi: 10.1186/s12874-018-0591-x.

  PMID: 30442094 BACKGROUND

• Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0.

  PMID: 36309746 BACKGROUND

• Singh N, Ahn J, Chen X, Park S, Singh S, Cardamone S, Davis R, Hsieh H, Moore RP. Improved Post-Operative Outcomes and Reduced Narcotic Use With ERAS Protocol in a Pediatric Ambulatory Surgery Setting. Paediatr Neonatal Pain. 2025 Mar 10;7(1):e70004. doi: 10.1002/pne2.70004. eCollection 2025 Mar.

  PMID: 40066436 BACKGROUND

• Selesner L, Gutierrez A, Vaughn C, Graveson A, Yoo A, Wooten A, Wilson R, Jafri M, Azarow K, Krishnaswami S, Fialkowski E. Standardized Perioperative Protocols and Variance in Pediatric Surgery. JAMA Surg. 2025 Oct 1;160(10):1108-1116. doi: 10.1001/jamasurg.2025.2927.

  PMID: 40833680 BACKGROUND

• Roberts K, Brindle M, McLuckie D. Enhanced recovery after surgery in paediatrics: a review of the literature. BJA Educ. 2020 Jul;20(7):235-241. doi: 10.1016/j.bjae.2020.03.004. Epub 2020 May 6. No abstract available.

  PMID: 33456956 BACKGROUND

• Strine AC, Chu DI, Brockel MA, Wilcox DT, Vricella GJ, Coplen DE, Traxel EJ, Chaudhry R, VanderBrink BA, Yerkes EB, Chan YY, Burjek NE, Zee RS, Herndon CDA, Ahn JJ, Merguerian PA, Meenakshi-Sundaram B, Rensing AJ, Frimberger D, Rove KO; PURSUE Study Group. Feasibility of Enhanced Recovery After Surgery (ERAS) implementation in Pediatric Urology: Pilot-phase outcomes of a prospective, multi-center study. J Pediatr Urol. 2024 Apr;20(2):256.e1-256.e11. doi: 10.1016/j.jpurol.2023.12.017. Epub 2023 Dec 30.

  PMID: 38212167 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Officials

• Ahmet B DOĞAN, Associate Professor

  Erciyes University, Faculty of Medicine, Department of Pediatric Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmet B DOĞAN, Associate Professor

CONTACT

+90 533 390 86 34; drkarden@gmail.com

Yasin Sipahi, Research Assistant

CONTACT

+90 507 119 00 58; sipahiysn@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single-arm prospective implementation cohort of consecutive eligible pediatric patients (5-18 years, ASA I-II) with non-complicated acute appendicitis undergoing minimally invasive (laparoscopic) appendectomy. All participants receive the same 20-item multidisciplinary ERAS care pathway as institutional standard during the pilot period. No concurrent control group; comparison anchors are pre-specified literature thresholds (compliance \>=80% with 95% CI lower bound \>70%; major complications and 30-day unplanned readmission both \<5%) and a retrospective descriptive baseline from the preceding 6 months at the same institution. The protocol includes a structured Run-in/Vanguard phase (first 5 patients) with explicit Decision A/B logic for protocol stability or revision before full enrollment, and audit-and-feedback cycles every 20 patients to monitor compliance drift.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 11, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

TU (1)