Video-based grading of intraoperative adverse events during pediatric laparoscopic appendectomy
Official title: Grading of Intraoperative Adverse Events With the ClassIntra Classification System and Their Association With Postoperative Complications in Pediatric Laparoscopic Appendectomy: A Prospective Video-Based Pilot Study
Run by TC Erciyes University · NCT07794618 · Data updated 2026-11-12
This project tests whether using video recordings and ClassIntra can reliably grade intraoperative adverse events in children undergoing laparoscopic appendectomy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 5 Years to 17 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | TC Erciyes University Academic / other |
| Locations | 1 site (Kayseri, Kayseri) |
| Status | Recruiting |
| Started | September 1, 2026 |
| Main results expected | July 15, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT07794618 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children ages 5 to under 18 with non-complicated acute appendicitis scheduled for laparoscopic appendectomy, ASA I-II, with parental consent and appropriate child assent.
✕Probably not a fit
Children with complicated appendicitis or higher anesthesia risk (ASA III or higher) may not benefit from this study's grading approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center observational study aims to apply the ClassIntra five-level severity scale to intraoperative events during pediatric laparoscopic appendectomy and to explore its reliability on video recordings. It focuses on non-complicated acute appendicitis in patients aged 5 to under 18 and excludes more severe disease. The goal is to understand how intraoperative event severity relates to postoperative complications, using pediatric-specific classifications where applicable. Eligible participants include children undergoing planned laparoscopic appendectomy with standard ASA I-II risk and parental consent, with assent where appropriate. Results may inform pediatric surgical safety auditing and the future development of pediatric-focused iAE assessment tools.
Why it matters
Potential benefit: If successful, the study could improve how surgeons document and communicate intraoperative risks in pediatric appendectomy, potentially guiding safety improvements.
How similar studies have gone: Previous adult-validated iAE tools and a few pediatric reports suggest potential utility, but pediatric video-based reliability data and appendectomy-specific use are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
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Erciyes University Faculty of Medicine, Department of Pediatric Surgery
Kayseri, Kayseri, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Ahmet Burak Doğan, MD
- Email: abdogan@erciyes.edu.tr
- Phone: +90 352 207 66 66
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.