NCT07643285 Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
| NCT ID | NCT07643285 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ahmet Burak Doğan, MD |
| Condition | Appendectomy, Laparoscopic |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-06-15 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Pediatric patients aged 5 to 18 years (preschool, school-age, and adolescent). 2. Acute appendicitis without preoperative radiologic or clinical evidence of complication/perforation, who are candidates for and accept laparoscopic surgery. 3. ASA Physical Status I (healthy) or ASA II (mild systemic disease). 4. Family/legal guardians literate in Turkish (or the institution's primary service language) and able to comprehend the educational materials. 5. Written informed consent from parents/legal guardians; for children of sufficient developmental maturity (generally ≥7 years), age-appropriate written assent. Exclusion Criteria: 1. 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). 2. History of chronic pain syndrome or regular/sustained opioid use within the past 3 months. 3. Therapeutic preoperative antibiotic treatment for an active infection (other than surgical prophylaxis). 4. ASA III or higher; immunosuppression, progressive neurological disease, chronic inflammatory bowel disease, or other significant comorbidities likely to interfere with postoperative recovery/mobilization. 5. Anatomic/mechanical contraindications to laparoscopy or pneumoperitoneum (e.g., prior major open abdominal surgery with suspected adhesions, abdominal wall defects).
Contact & Investigator
Ahmet B DOĞAN, Associate Professor
PRINCIPAL INVESTIGATOR
Erciyes University, Faculty of Medicine, Department of Pediatric Surgery
Frequently Asked Questions
Who can join the NCT07643285 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 18 Years, studying Appendectomy, Laparoscopic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07643285 currently recruiting?
Yes, NCT07643285 is actively recruiting participants. Contact the research team at drkarden@gmail.com for enrollment information.
Where is the NCT07643285 trial being conducted?
This trial is being conducted at Kayseri, Turkey (Türkiye).
Who is sponsoring the NCT07643285 clinical trial?
NCT07643285 is sponsored by Ahmet Burak Doğan, MD. The principal investigator is Ahmet B DOĞAN, Associate Professor at Erciyes University, Faculty of Medicine, Department of Pediatric Surgery. The trial plans to enroll 100 participants.