Validating the Novel Classification for the Assessment and Grading of Unexpected Events in Pediatric Surgery: The Clavien-Madadi Classification

NCT05778019 | Unknown

• 1 other identifier: 9557_BO_K_2021_2
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Despite appraisal of the Clavien-Dindo classification in the pediatric surgical literature, some criticize the transfer of the grading systems for adults in a pediatric cohort without modifications. In a recent study it has been shown that few items of the classification do not offer additional information in pediatric cohorts and organizational and management errors have been integrated, not being part of the initial proposal by Dindo et al. In a group of pediatric and general surgeons, methodologists and statisticians of the ERNICA network the Clavien-Dindo classification has been modified for the application in pediatric surgery. The aim is to test and validate the novel Clavien-Madadi classification in a pediatric surgical cohort.

Conditions

Complication of Surgical Procedure

Keywords

Complications; Unexpected events; Severity Grading Systems; Classifications; Clavien-Madadi; Clavien-Dindo

Outcome Measures

Primary Outcomes (1)

• Grading according to the Clavien-Madadi classification

  Grading of constructed case scenarios (by an international working group). Grading according to the Clavien-Madadi classification: Grade Ia - organizational and management errors Grade Ib - any deviation from the planned clinical course Grade II - pharmacological treatment Grade IIIa - Re-interventions (minimally-invasive) Grade IIIb - Re-interventions (laparotomy and / or thoracotomy) Grade IV - multiorgan dysfunction Grade V - death

  Three months

Secondary Outcomes (2)

• Grading according to the Clavien-Dindo classification

  Three months

• Comparison of Clavien-Madadi and Clavien-Dindo classification

  Three months

Study Arms (1)

Case Scenarios

No personal patient information is shared. The circulated case scenarios within the network will be constructed cases from the clinical practice, to serve representatively

Other: Case Scenarios of complications to be ranked / classified according to classifications (for the severity grading of events)

Interventions

Case Scenarios of complications to be ranked / classified according to classifications (for the severity grading of events) OTHER

Test the feasibility, applicability and logic of a novel instrument for the grading of unexpected events in pediatric surgery (Clavien-Madadi classification) compared to the Clavien-Dindo classification for the grading of postoperative complications in general surgery

Also known as: Comparison of the Clavien-Dindo and Clavien-Madadi classification

Case Scenarios

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The constructed case scenarios will especially focus on congenital diseases, however, the spectrum of pediatric surgery (age: preterm infants to 17 years of age) will be included in the scenarios (if necessary)

You may qualify if:

• Case scenarios of unexpected events
• Case scenarios on neonatal surgery
• Case scenarios on congenital malformations
• Case scenarios with (re-)interventions
• Case scenarios with organ impairment
• Case scenarios with fatal result

You may not qualify if:

• Complex constructed case scenarios
• Case scenarios with adult patients
• Case scenarios with multiple events

Sponsors & Collaborators

• Hannover Medical School: lead
• Karolinska Institutet: collaborator
• Helsinki University Central Hospital: collaborator
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• Ospedale dei Bambini Milano: collaborator
• University of Leipzig: collaborator
• Namik Kemal University School of Medicine, Tekirdag: collaborator

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30655, Germany

RECRUITING

Related Publications (5)

• Sethi MV, Zimmer J, Ure B, Lacher M. Prospective assessment of complications on a daily basis is essential to determine morbidity and mortality in routine pediatric surgery. J Pediatr Surg. 2016 Apr;51(4):630-3. doi: 10.1016/j.jpedsurg.2015.10.052. Epub 2015 Oct 27.

  PMID: 26628204 RESULT

• Madadi-Sanjani O, Zoeller C, Kuebler JF, Hofmann AD, Dingemann J, Wiesner S, Brendel J, Ure BM. Severity grading of unexpected events in paediatric surgery: evaluation of five classification systems and the Comprehensive Complication Index (CCI(R)). BJS Open. 2021 Nov 9;5(6):zrab138. doi: 10.1093/bjsopen/zrab138.

  PMID: 35022674 RESULT

• Madadi-Sanjani O, Brendel J, Uecker M, Pfister ED, Baumann U, Ohlendorf J, Kuebler JF. Accumulation of Postoperative Unexpected Events Assessed by the Comprehensive Complication Index(R) as Prognostic Outcome Parameters for Kasai Procedure. Children (Basel). 2022 Oct 20;9(10):1590. doi: 10.3390/children9101590.

  PMID: 36291526 RESULT

• Madadi-Sanjani O, Brendel J, Kuebler JF, Ure BM. Definition, Documentation, and Classification of Complications in Pediatric Surgical Literature-A Plea for Standardization. Eur J Pediatr Surg. 2023 Apr;33(2):105-113. doi: 10.1055/s-0043-1760835. Epub 2023 Jan 31.

  PMID: 36720251 RESULT

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 RESULT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 21, 2023
• Study Start: December 1, 2022
• Primary Completion: May 31, 2023
• Study Completion: July 31, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)