Who may be eligible for this acute appendicitis clinical trial?

Children aged 5 to 18 with non-complicated acute appendicitis suitable for laparoscopic surgery may be eligible. Participants must be generally healthy or have mild systemic disease and have family members who can understand educational materials. Please review eligibility criteria for more details.

Is there any cost to participate in this acute appendicitis clinical trial?

Study-related care, including the protocol and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants can expect all necessary care during their hospital stay to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 5Years - 18Years

All Genders

ID07643285

Evaluating a Pediatric Enhanced Recovery After Surgery Program for Children Aged 5 to 18 Undergoing Laparoscopic Appendectomy to Assess Safety and Feasibility

Q: What is this study trying to find out about acute appendicitis in children?

This study is evaluating whether a comprehensive Enhanced Recovery After Surgery (ERAS) protocol can be successfully and safely applied to children aged 5 to 18 undergoing laparoscopic appendectomy for non-complicated acute appendicitis. It aims to improve recovery by reducing complications and opioid use. The study is led by Dr. Ahmet Burak Doğan and takes place at a specialized pediatric surgery center.

Led by Ahmet Burak Doğan, MD · Updated on 2026-07-30

100

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Acute appendicitis is a common surgical emergency in children, and this study evaluates the implementation of a comprehensive 20-item Enhanced Recovery After Surgery ERAS protocol for pediatric patients aged 5 to 18 undergoing laparoscopic appendectomy for non-complicated acute appendicitis. The study is a single-center, prospective, single-arm cohort feasibility study aiming to assess the protocols compliance and safety, following the IDEAL Stage 2a framework. The goal is to reduce variations in postoperative care such as prolonged fasting and opioid use, which can affect recovery outcomes. The ERAS protocol covers the entire perioperative period with specific interventions before, during, and after surgery. Preoperative items include family education and fasting management intraoperative items involve timely antibiotics, regional analgesia, restricted opioid use, active temperature control, and avoidance of routine drains postoperative items focus on early removal of tubes, early oral feeding, mobilization, and multimodal oral analgesia. The first five patients undergo a run-in phase to assess safety and compliance, with ongoing audits every 20 patients to monitor adherence and guide any needed protocol revisions. Participants will be actively monitored throughout their hospital stay, with evaluations including medical readiness for discharge, length of stay, opioid consumption, and parent-reported outcomes like anxiety and satisfaction. The study also integrates surveys of healthcare providers to assess knowledge and attitudes. Safety is closely tracked through complication and readmission rates within 30 days post-surgery. The total study duration spans from admission through discharge, typically around 72 hours, with follow-up for 30 days to assess safety outcomes.

CONDITIONS

Brief Title

Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy

Who Can Participate

Age: 5Years - 18Years

All Genders

Eligibility Criteria

You may qualify if you...

Pediatric patients aged 5 to 18 years
Diagnosed with acute appendicitis without complications and suitable for laparoscopic surgery
ASA Physical Status I (healthy) or II (mild systemic disease)
Family or legal guardians able to understand educational materials in the primary language
Written informed consent from parents or guardians; assent from children aged 7 years or older

You will not qualify if you...

Evidence of complicated appendicitis requiring extended surgery
History of chronic pain syndrome or regular opioid use in past 3 months
Receiving therapeutic antibiotics for active infection before surgery
ASA Physical Status III or higher, immunosuppression, neurological disease, inflammatory bowel disease, or other major comorbidities
Anatomical or mechanical reasons preventing laparoscopic surgery (e.g., prior major abdominal surgery with adhesions)

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Approximately 72 hours (index hospitalization)

Participants follow the 20-item pediatric ERAS protocol including preoperative education, fasting management, intraoperative care with specific anesthesia and analgesia, and postoperative early feeding and mobilization.

Hospital stay with daily monitoring