Comprehensive Complication Index in the Classification of Complications of Percutaneous Nephrolithotomy
Clinical Validation and Evaluation of Reliability of Comprehensive Complication Index (CCI) for Recording Percutaneous Nephrolithotomy Complications
1 other identifier
observational
644
1 country
1
Brief Summary
Postoperative complications should be reported systematically, objectively and reproducibly. The Clavien-Dindo Classification (CDC), first described in 2004, is the most popular classification system still in use today for assessing perioperative morbidity and mortality. In 2018, the European Association of Urology (EAU) validated this classification, which was originally defined for general surgery operations, for urological operations as well. There are aspects of the CDC that can be critical and weak. The CDC's main weakness is that in the vast majority of studies it only considers the most serious complications. Minor complications are often overlooked and the overall complication burden is therefore underestimated. Because of this vulnerability, it is difficult to compare complications from different patients. For example, it cannot be determined whether a patient with two Grade I complications has higher postoperative morbidity than a patient with one Grade II complication. To address these limitations, the Comprehensive Complications Index (CCI) was defined in 2013 as a new and more comprehensive scoring system for surgical complications. The CCI is essentially an index based on the CDC, but sums all postoperative complications by severity and scores them on an interval scale. It is scored from 0 (no complications) to 100 (patient's death) for each patient. CCI in Urology Practice; Validated for Radical Cystectomy, Radical Prostatectomy, Radical Nephroureterectomy, Partial Nephrectomy. In recent years, validation studies of this index have been carried out in endourological surgeries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2022
CompletedFirst Posted
Study publicly available on registry
April 28, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2023
CompletedApril 28, 2022
April 1, 2022
12 months
April 22, 2022
April 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Comprehensive Complication Index
The comprehensive complications index was proposed as a novel comprehensive scoring system for surgical complications in 2013. It's scoring complications on an interval scale between 0 (no complication) and 100 (death of the patient) for each patient.
within 2 months post-procedure
Clavien-Dindo-Classification score
The Clavien-Dindo-Classification (CDC), first described in 2004, is the most popular classification system for assessing perioperative morbidity and mortality.
within 2 months post-procedure
Eligibility Criteria
Patient group over 18 years of age with kidney stones and no contraindications for PCNL
You may qualify if:
- To have a medical indication for percutaneous kidney stone surgery
- To have given consent to participate in the study
- To be18 years of age or older
You may not qualify if:
- To be under the age of 18
- Not to have given consent to participate in the study
- Not to have a medical indication for percutaneous kidney stone surgery
- To Have an orthopedic disorder that prevents him from undergoing percutaneous kidney stone surgery
- To have a hematological disorder that prevents percutaneous kidney stone surgery
- To have a malignancy that prevents percutaneous kidney stone surgery
- To have a serious cardiac and respiratory comorbidities that prevent percutaneous kidney stone surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marmara Universitylead
- Zonguldak Bulent Ecevit Universitycollaborator
- Ankara Universitycollaborator
- Inonu Universitycollaborator
- Istanbul Universitycollaborator
- Acibadem Universitycollaborator
- Eskisehir Osmangazi Universitycollaborator
- Başakşehir Çam & Sakura City Hospitalcollaborator
- Koç Universitycollaborator
- Izmir Metropolitan Municipality Esrefpasa Hospitalcollaborator
- Alanya Alaaddin Keykubat Universitycollaborator
- Cukurova Universitycollaborator
- Ondokuz Mayıs Universitycollaborator
- Dokuz Eylul Universitycollaborator
- Samsun Education and Research Hospitalcollaborator
- Gazi Universitycollaborator
- Hacettepe Universitycollaborator
- Abant Izzet Baysal Universitycollaborator
- Ankara Training and Research Hospitalcollaborator
- Hitit Universitycollaborator
- Baskent Universitycollaborator
Study Sites (1)
Zonguldak Bülent Ecevit University, school of medicine
Zonguldak, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Reha GİRGİN, Assist.Prof.
Zonguldak Bulent Ecevit University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associ.Prof.
Study Record Dates
First Submitted
April 22, 2022
First Posted
April 28, 2022
Study Start
May 1, 2022
Primary Completion
April 30, 2023
Study Completion
April 30, 2023
Last Updated
April 28, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share