AzTrials
AzTrials

Complication of Surgical ProcedureComPedSNCT05778019

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

An observational study of Complication of Surgical Procedure, run by Hannover Medical School at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 day to 17 years
Conditions the study is for
Complication of Surgical Procedure
What is being tested?
Case Scenarios of complications to be ranked / classified according to classifications (for the severity grading of events)
How many people
20 participants
Where
1 siteGermany
Study dates
1 Dec 2022to 31 Jul 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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)

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site, 1 recruiting

  • Hannover Medical School

    Hanover, Lower Saxony, 30655

    Omid Madadi-Sanjani, +4917620192676, madadi.sanjani@gmail.com

    Recruiting

Other trials in Germany

About this study

Official title: Validation of Clavien-Madadi Classification for the Grading of Unexpected Events in Pediatric Surgery

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.

Read the detailed description

Based on the protocol by Dindo et al. for the assessment of the international acceptability and reproducibility of the Clavien-Dindo classification, the aim is to circulate case scenarios (of complications/ unexpected events) within the ERNICA (European Reference Network for Rare Inherited Congenital Anomalies) network. Those case scenarios (15-20) should be graded by the respondents according to the Clavien-Dindo and Clavien-Madadi classification and preferences for future practice should be reported.

Milestones

  1. All members of the working group send the PI´s 1-2 case scenarios with unexpected events in the management and treatment of neonates (preferably congenital diseases) and children for each grade of the Clavien-Madadi classification
  2. All case scenarios will be circulated within the working group and will be ranked with a Likert scale (1 not accurate - 5 accurate) regarding the plausibility for an international survey
  3. A final proposal of 15-20 case scenarios will be circulated within the working group
  4. Circulating the case scenarios and the additional questionnaire via the ERNICA email distribution system and newsletter
Being tested
Case Scenarios of complications to be ranked / classified according to classifications (for the severity grading of events)
Keywords
Complications, Unexpected events, Severity Grading Systems, Classifications, Clavien-Madadi, Clavien-Dindo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Comparison of the Clavien-Dindo and Clavien-Madadi classification

    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

Study groups in NCT05778019
Study groupRoleWhat they receive
Case ScenariosNo personal patient information is shared. The circulated case scenarios within the network will be constructed cases from the clinical practice, to serve representatively
Receives: Other: Case Scenarios of complications to be ranked / classified according to classifications (for the severity grading of events)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Three months

Secondary outcomes (2)

  1. Grading according to the Clavien-Dindo classification

    Grading of constructed case scenarios (by an international working group)

    Grading according to the Clavien-Dindo classification:

    Grade I - any deviation from the planned postoperative course Grade II - pharmacological treatment Grade IIIa - Re-interventions not under general anesthesia Grade IIIb - Re-interventions under general anesthesia Grade IVa - single-organ dysfunction Grade IVb - multiorgan dysfunction Grade V - death

    Measured: Three months

  2. Comparison of Clavien-Madadi and Clavien-Dindo classification

    For each case scenario the respondents will have the option to select the superior classification (or specify no difference)

    Measured: Three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2023
  2. Study start1 Dec 2022
  3. Primary completion31 May 2023 (estimated)
  4. Study completion31 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05778019
Sponsor's protocol ID
9557_BO_K_2021_2
Acronym
ComPedS
Status last verified
Mar 2023
First submitted
27 Feb 2023
Last updated
21 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No individual participant data is necessary in our protocol. We will be focussing on constructed case scnearios, not including any specific patient data at all

Publications

  • 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.

    PubMed 26628204

  • 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.

    PubMed 35022674

  • 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.

    PubMed 36291526

  • 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.

    PubMed 36720251

  • 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.

    PubMed 15273542

Questions about this trial

What is this clinical trial studying?

An observational study of Complication of Surgical Procedure, run by Hannover Medical School at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grading according to the Clavien-Madadi classification (time frame: Three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05778019, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in