A new lens on children's surgery: can video grading predict recovery?
NCT ID NCT07794618
First seen Aug 31, 2026 · Last updated Sep 04, 2026 · Updated 4 times
Summary
This pilot study tests whether a tool called ClassIntra, used to grade unexpected events during surgery, can be applied to children having their appendix removed. Researchers will record the operations of 80 children aged 5 to 17 and have two independent surgeons review the videos to classify any issues. They will then check whether these grades relate to complications within 30 days after surgery. The goal is to see if this grading system is practical and reliable for pediatric surgery, not to change how the operation is performed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Laparoscopic appendectomy (standard care, with video recording and independent grading of intraoperative events)
- What this could lead to
- If the grading system works in children, it could become a standard tool to spot surgical problems early and improve recovery after pediatric appendix surgery.
- What could go wrong
- This is a small pilot study, so the results may not apply to all hospitals or surgeons. The grading system might not be reliable enough in children, and the study does not change how surgery is done.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Consecutive children aged 5 to under 18 years who present to a single tertiary academic pediatric surgery department with non-complicated acute appendicitis and undergo laparoscopic appendectomy performed by the principal investigator, and whose parents or legal guardians provide written informed consent.
- Ages
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5 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Erciyes University Faculty of Medicine, Department of Pediatric Surgery
RECRUITINGKayseri, Kayseri, 38039, Turkey (Türkiye)
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- Calming senses before surgery: a new way to soothe anxious kids?
- To cut or not to cut: a trial questions routine appendectomy for normal appendices