[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642644":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":34,"responsibleParty":58,"collaborators":19,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":19,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":19,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":19,"overallStatus":37,"whyStopped":19,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"TC Erciyes University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: Comprehensive 20-Item Pediatric ERAS Protocol",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Comprehensive 20-Item Pediatric ERAS Protocol","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 \\\u003C0.1 mg\u002Fkg morphine equivalent, active normothermia \\>36 °C, goal-directed euvolemic fluid therapy 3-7 mL\u002Fkg\u002Fh, minimally invasive surgical approach, avoidance of routine drains\u002Ftubes, universal PONV prophylaxis with ondansetron + dexamethasone 0.15 mg\u002Fkg 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\u002F",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Ahmet B DOĞAN, Associate Professor","Erciyes University, Faculty of Medicine, Department of Pediatric Surgery","PRINCIPAL_INVESTIGATOR",[26,30],{"name":22,"role":27,"phone":28,"phoneExt":19,"email":29},"CONTACT","+90 533 390 86 34","drkarden@gmail.com",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},"Yasin Sipahi, Research Assistant","+90 507 119 00 58","sipahiysn@hotmail.com",[35],{"facility":36,"status":37,"city":38,"state":38,"zip":39,"country":40,"countryCode":19,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Erciyes University Faculty of Medicine, Department of Pediatric Surgery","RECRUITING","Kayseri","38039","Turkey (Türkiye)",{"type":42,"coordinates":43},"Point",[44,45],35.48528,38.73222,{"lat":45,"lon":44},[48,50,51,52,54,56],{"name":49,"role":27,"phone":28,"phoneExt":19,"email":29},"Ahmet DOĞAN, Associate Professor",{"name":31,"role":27,"phone":32,"phoneExt":19,"email":33},{"name":22,"role":24,"phone":19,"phoneExt":19,"email":19},{"name":31,"role":53,"phone":19,"phoneExt":19,"email":19},"SUB_INVESTIGATOR",{"name":55,"role":53,"phone":19,"phoneExt":19,"email":19},"Karamehmet YILDIZ, Professor",{"name":57,"role":53,"phone":19,"phoneExt":19,"email":19},"Sibel S PEHLİVAN, Associate Professor",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"SPONSOR_INVESTIGATOR","Ahmet Burak Doğan, MD","Associate Professor","100642644","feasibility-and-safety-of-a-pediatric-eras-protocol-for-laparoscopic-appendectomy-100642644",false,"NCT07643285","Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy","Clinical Outcomes and Institutional Integration of the ERAS (Enhanced Recovery After Surgery) Protocol in Pediatric Appendicetomies: A Mixed Methodological IDEAL (Idea, Development, Exploration, Assessment, Long-term Study) 2a Preliminary Study","Inclusion Criteria:\n\n1. Pediatric patients aged 5 to 18 years (preschool, school-age, and adolescent).\n2. Acute appendicitis without preoperative radiologic or clinical evidence of complication\u002Fperforation, who are candidates for and accept laparoscopic surgery.\n3. ASA Physical Status I (healthy) or ASA II (mild systemic disease).\n4. Family\u002Flegal guardians literate in Turkish (or the institution's primary service language) and able to comprehend the educational materials.\n5. Written informed consent from parents\u002Flegal guardians; for children of sufficient developmental maturity (generally ≥7 years), age-appropriate written assent.\n\nExclusion Criteria:\n\n1. 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).\n2. History of chronic pain syndrome or regular\u002Fsustained opioid use within the past 3 months.\n3. Therapeutic preoperative antibiotic treatment for an active infection (other than surgical prophylaxis).\n4. ASA III or higher; immunosuppression, progressive neurological disease, chronic inflammatory bowel disease, or other significant comorbidities likely to interfere with postoperative recovery\u002Fmobilization.\n5. Anatomic\u002Fmechanical contraindications to laparoscopy or pneumoperitoneum (e.g., prior major open abdominal surgery with suspected adhesions, abdominal wall defects).","ALL","5 Years","18 Years",{"count":73,"type":74},100,"ESTIMATED","INTERVENTIONAL",[77],"NA","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.\n\nThis 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 \\\u003C5%. Secondary endpoints include time to medical readiness for discharge, actual length of stay, opioid sparing, and parent-reported outcomes.\n\nThe 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.",[80,81,82,83],"Appendectomy, Laparoscopic","Acute Appendicitis","Pediatric Surgery","ERAS","2026-06-28",{"date":86,"type":87},"2026-07-01","ACTUAL",{"date":89,"type":87},"2026-06-16",{"date":91,"type":74},"2027-08",{"name":60,"class":6},1]