Pediatric ERAS-Adapted Laparoscopic Appendectomy Feasibility

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, single-arm feasibility study (IDEAL Stage 2a) evaluating a comprehensive 20-item pediatric ERAS protocol for non-complicated acute appendicitis in children 5–18 undergoing laparoscopic surgery. The trial focuses on implementing the protocol with high fidelity while monitoring safety and feasibility, aiming for about 100 enrolled patients to yield ~80 evaluable cases. Outcomes center on protocol adherence, safety endpoints, and measures related to recovery after surgery. The study acknowledges potential operational challenges in emergent contexts and proposes local validation before broader adoption. The protocol targets reductions in postoperative opioid use, faster feeding, and shortened length of stay through multidisciplinary perioperative care elements.

Why it matters

Who can join: the full rules

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).

Where it's running

• Erciyes University Faculty of Medicine, Department of Pediatric Surgery
  Kayseri, Kayseri, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Ahmet B DOĞAN, Associate Professor — Erciyes University, Faculty of Medicine, Department of Pediatric Surgery
• Study coordinator: Ahmet B DOĞAN, Associate Professor
• Email: drkarden@gmail.com
• Phone: +90 533 390 86 34

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Inflammatory biomarkers in blood and appendix tissue in acute appendicitis

  This study tests whether blood and appendix tissue biomarkers correlate with how severe a patient’s acute appendicitis is, to help distinguish uncomplicated from complicated cases.

  Recruiting Haydarpasa Numune Training and Research Hospital · Istanbul, Istanbul · NCT07926165

• Test of Pro-Adrenomedullin for diagnosing acute appendicitis in adults

  We are testing whether Pro-Adrenomedullin can help diagnose acute appendicitis in adults and how it compares to CRP and NLR.

  Recruiting Bursa Yuksek Ihtisas Training and Research Hospital · Bursa · NCT07889544

• Effect of extraction site and local anesthesia on pain after laparoscopic appendectomy

  This study tests whether using the periumbilical versus left lower quadrant extraction site and routine port-site local anesthesia affect postoperative pain in adults with acute appendicitis undergoing laparoscopic appendectomy.

  Recruiting Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Diyarbakır, Kayapınar · NCT07824908

• Video-based grading of intraoperative adverse events during pediatric laparoscopic appendectomy

  This project tests whether using video recordings and ClassIntra can reliably grade intraoperative adverse events in children undergoing laparoscopic appendectomy.

  Recruiting TC Erciyes University · Kayseri, Kayseri · NCT07794618

• Enhanced Recovery After Surgery for Gynecologic Procedures

  This study tests whether an ERAS program can help women undergoing gynecologic surgery recover faster compared with traditional perioperative care.

  Recruiting National Taiwan University Hospital · Hsinchu · NCT07764276

• Maltodextrin in the Preoperative Fast for Kids in ERAS

  This pilot study tests whether giving maltodextrin before surgery helps reduce anxiety and improve recovery in children aged 3 to 8 undergoing elective day surgery.

  Recruiting Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Alessandria, Piedmont · NCT07686029

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.