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

NCT07794618 | Recruiting

• 2 other identifiers: PedAppy-iAE-20262026/407
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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 graded event severity and postoperative complication severity graded with the pediatric-specific Clavien-Madadi classification has not been examined in children. This prospective, single-center, single-surgeon, video-based pilot study (IDEAL Framework Stage 2a) evaluates whether ClassIntra can be feasibly applied to the laparoscopic phase of pediatric appendectomy. Eighty children aged 5 to under 18 years undergoing laparoscopic appendectomy for non-complicated acute appendicitis will be enrolled. Operative videos will be recorded, de-identified, assigned a case code, and independently assessed in randomized order by two pediatric surgeons from outside the operating institution, who remain blinded to all postoperative clinical data. Each observed event is characterized on three levels: event type (E1-E7), mechanism (GERT categories M1-M4), and severity (ClassIntra Grade I-V). Postoperative complications within 30 days are graded separately with the Clavien-Madadi classification by the principal investigator, independently of the video assessment. The primary outcome is the feasibility of ClassIntra in this setting, evaluated as a progression-criteria profile rather than a composite rule, using three pre-specified criteria: inter-rater reliability (Gwet's AC1 \>= 0.60, the key indicator), applicable coverage (proportion of non-assessable cases \< 5%), and discriminative capacity (at least three of the five ClassIntra grades represented in the cohort). Secondary outcomes are descriptive: iAE incidence with Wilson score confidence intervals and the distribution of event types, mechanisms and severity grades. Exploratory hypotheses examine the association of intraoperative event severity with adherence to the institutional Enhanced Recovery After Surgery (ERAS) protocol, with time to medical readiness for discharge, and with Clavien-Madadi-graded postoperative complication severity. The study involves no additional intervention, investigational product, or extra procedure for the participating children; care follows institutional standards throughout. Its purpose is to provide feasibility evidence and calibration parameters for subsequent multicenter validation studies, not to establish the validity of the classification system itself.

Conditions

Appendicitis, Acute; Appendectomy; Intraoperative Complications; Patient Safety; Pediatric Surgery

Keywords

ClassIntra; Clavien-Madadi; Intraoperative adverse events; Laparoscopic appendectomy; Video-based assessment; Inter-rater reliability; Gwet's AC1; IDEAL Framework Stage 2a; Pediatric surgery; Surgical safety

Outcome Measures

Primary Outcomes (3)

• Inter-Rater Reliability of ClassIntra Grading (Key Feasibility Indicator)

  Agreement between two independent, blinded pediatric surgeon raters on the ClassIntra severity grade assigned to the laparoscopic phase of each operation, quantified with Gwet's AC1. The pre-specified feasibility threshold is AC1 \>= 0.60. Weighted Kappa and the intraclass correlation coefficient are reported as supporting measures. As a pre-specified sensitivity analysis, AC1 is additionally computed in the subset of videos with at least one identified intraoperative adverse event, since agreement on event-free cases is expected to be high and uninformative about grading discrimination. This is the key indicator of the feasibility profile; the three feasibility criteria are reported separately as progression criteria and are not combined into a composite rule.

  Intraoperative period (laparoscopic phase of each operation); reliability computed across the evaluable cohort at database lock, approximately 10 months after study start.

• Applicable Coverage of ClassIntra (Supporting Feasibility Indicator)

  Proportion of enrolled cases that cannot be graded with ClassIntra by the raters, for any reason including insufficient video quality or incomplete assessment. The pre-specified feasibility threshold is a non-assessable proportion below 5%. Reported as a proportion with a 95% confidence interval, together with the reason for each non-assessable case.

  Intraoperative period (laparoscopic phase of each operation); computed across the enrolled cohort at database lock, approximately 10 months after study start.

• Discriminative Capacity of ClassIntra (Supporting Feasibility Indicator)

  Number of distinct ClassIntra severity grades (of the five possible grades, I to V) represented in the study cohort. The pre-specified feasibility threshold is representation of at least three of the five grades. The full grade distribution is additionally reported descriptively. No entropy or dispersion threshold is applied.

  Intraoperative period (laparoscopic phase of each operation); computed across the evaluable cohort at database lock, approximately 10 months after study start.

Secondary Outcomes (5)

• Incidence of Intraoperative Adverse Events

  Intraoperative period (laparoscopic phase of each operation).

• Distribution of Intraoperative Adverse Events by Event Type, Mechanism and Severity

  Intraoperative period (laparoscopic phase of each operation).

• Association Between Intraoperative Event Severity and Institutional ERAS Protocol Adherence (Exploratory)

  Index hospitalization, from admission to actual discharge (typically up to 72 hours).

• Association Between Intraoperative Event Severity and Time to Medical Readiness for Discharge (Exploratory)

  From arrival in the post-anesthesia care unit until medical readiness for discharge, typically up to 48 hours.

• Association Between Intraoperative Event Severity and Postoperative Complication Severity (Exploratory)

  30 days after surgery.

Study Arms (1)

Pediatric laparoscopic appendectomy cohort

Children aged 5 to under 18 years undergoing laparoscopic appendectomy for non-complicated acute appendicitis, whose operative video is recorded and independently graded for intraoperative adverse events. No intervention is assigned; all care follows institutional standards.

Procedure: Laparoscopic appendectomy

Interventions

Laparoscopic appendectomy PROCEDURE

Laparoscopic appendectomy performed as standard institutional care for non-complicated acute appendicitis. The study assigns no intervention: the procedure is routine care, and its operative video is recorded and independently graded for intraoperative adverse events during the laparoscopic phase.

Pediatric laparoscopic appendectomy cohort

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age 5 to under 18 years.
• Diagnosis of non-complicated acute appendicitis, based on clinical, laboratory and imaging findings.
• Laparoscopic appendectomy planned.
• General condition allowing standard surgical management and its associated complication risk (ASA Physical Status I or II).
• Written informed consent provided by a parent or legal guardian.
• 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.

You may not qualify if:

• Complicated appendicitis (perforation, periappendicular abscess, or peritonitis).
• Emergency surgery for a non-appendicitis indication (e.g. ileus, intussusception).
• Elective interval appendectomy (late procedure following complicated appendicitis).
• Comorbidity corresponding to ASA Physical Status III or higher.
• Conditions that markedly increase surgical risk, such as a known coagulation disorder or immunodeficiency.

Sponsors & Collaborators

• Ahmet Burak Doğan, MD: lead

Study Sites (1)

Erciyes University Faculty of Medicine, Department of Pediatric Surgery

Kayseri, Kayseri, 38039, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Appendicitis; Intraoperative Complications

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmet Burak Doğan, MD

CONTACT

+90 352 207 66 66; abdogan@erciyes.edu.tr

Mustafa Özdemir, MD

CONTACT

+90 352 207 66 66; mustafa.oz@erciyes.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Department of Pediatric Surgery

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)