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Video-Based Grading of Intraoperative Adverse Events in Pediatric Laparoscopic Appendectomy

Recruitingn/aAges 5 Years - 17 YearsAllAhmet Burak Doğan, MD
NCT07794618 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Acute appendicitis is the most common surgical emergency in children, and laparoscopic appendectomy is its standard treatment. Although intraoperative adverse events (iAEs) are recognized as an important determinant of surgical safety and outcome, no validated tool exists for grading them in children. ClassIntra, an internationally validated five-level severity classification of intraoperative adverse events, has been validated in adults. Its use in children is limited to two single-centre cohorts - one in pediatric neurosurgery and one in a mixed pediatric robotic surgery programme - in which it was applied prospectively by the operating teams. Its inter-rater reliability has never been assessed in a pediatric population, it has not been applied to video-recorded pediatric procedures, and no study has focused on pediatric appendectomy. Likewise, the association between intraoperatively

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 5 to under 18 years. 2. Diagnosis of non-complicated acute appendicitis, based on clinical, laboratory and imaging findings. 3. Laparoscopic appendectomy planned. 4. General condition allowing standard surgical management and its associated complication risk (ASA Physical Status I or II). 5. Written informed consent provided by a parent or legal guardian. 6. For children aged 7 to under 18 years, additional written assent; for children aged 5 to 6 years, verbal agreement obtained with no active objection observed. Exclusion Criteria: 1. Complicated appendicitis (perforation, periappendicular abscess, or peritonitis). 2. Emergency surgery for a non-appendicitis indication (e.g. ileus, intussusception). 3. Elective interval appendectomy (late procedure following complicated appendicitis). 4. Comorbidity corresponding to ASA Physical Status III or higher. 5. Conditions that markedly increase surgical risk, such as a known coagulation disorder or immunodeficiency. 6. Intraoperative conversion from laparoscopic to open surgery (post-hoc exclusion, as it changes the surgical technique).
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What it tests

  • Laparoscopic appendectomy
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Where

1 site
Erciyes University Faculty of Medicine, Department of Pediatric Surgery
Kayseri, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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