Complications, PostoperativeNCT05351632
Comprehensive Complication Index in the Classification of Complications of Percutaneous Nephrolithotomy
An observational study of Complications, Postoperative, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications, Postoperative
- How many people
- 644 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 30 Apr 2023
- How long will I take part?
- 2 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient group over 18 years of age with kidney stones and no contraindications for PCNL
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University, school of medicine
Zonguldak
Reha Girgin, Assist.Prof., 05378865912, mujdereha7477@hotmail.com
Yilören TANIDIR, Associ.Prof., 05325694275, yiloren@yahoo.com
About this study
Official title: Clinical Validation and Evaluation of Reliability of Comprehensive Complication Index (CCI) for Recording Percutaneous Nephrolithotomy Complications
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.
Read more
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.
Read the detailed description
Percutaneous kidney stone surgery (PNL) will be performed due to kidney stones, and 644 patients will be included in the study according to the power analysis*. Demographic data of the patients, stone characteristics and data related to stone burden, data related to the operation will be noted by looking at the hospital files. Patients who have undergone surgery can be discharged after an average of 3 days and can be called for routine control after an average of 2 months. All complications developed during the inpatient follow-up and any complications developed during the control period will be noted using the patient's file information. Then, all these complications that are detected to develop will be scored separately using the CCI and CDC complication scales.
- Using the free online tool www.assessurgery.com, the Comprehensive Complications Index (CCI) score for the total burden of complications will be calculated for each patient.
- Each patient's most major complication will be determined and graded according to the Clavien-Dindo (CDC) classification (as described below).
Grade I: Any deviation from the normal postoperative course requiring only the following drugs: antiemetics, antipyretics, diuretics Grade II: Pharmacological therapy (with drugs not necessary for CDC I complications), blood transfusion, total parenteral nutrition Grade IIIa: Surgical, endoscopic or radiological intervention not under general anesthesia Grade IIIb: Surgical, endoscopic or radiological intervention under general anesthesia Grade IVa: single organ dysfunction requiring intensive care unit management Grade IVb: multiple organ dysfunction requiring intensive care unit management Grade V: Death
All the data obtained, CCI and CDC, will be compared among themselves in terms of reliability, demographic data obtained from the pre-operative file data, stone characteristics and data related to the operation will be compared, as well as their relationship with the length of hospital stay.
- Conditions
- Complications, Postoperative
- Keywords
- Comprehensive Complications Index, Percutaneous Nephrolithotomy, Complication
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: within 2 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications, PostoperativeStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 644 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Collaborators
- Zonguldak Bulent Ecevit University, Ankara University, Inonu University, Istanbul University, Acibadem University, Eskisehir Osmangazi University, Başakşehir Çam & Sakura City Hospital, Koç University, Izmir Metropolitan Municipality Esrefpasa Hospital, Alanya Alaaddin Keykubat University, Cukurova University, Ondokuz Mayıs University, Dokuz Eylul University, Samsun Education and Research Hospital, Gazi University, Hacettepe University, Abant Izzet Baysal University, Ankara Training and Research Hospital, Hitit University, Baskent University
- Responsible party
- Principal investigator, Yiloren Tanidir, Marmara University
- Investigators
- Reha GİRGİN, Assist.Prof., Study director, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351632
- Sponsor's protocol ID
- 2022/06-7
- Status last verified
- Apr 2022
- First submitted
- 22 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation and Evaluation of Reliability of Comprehensive Complication Index (CCI) for Recording Percutaneous Nephrolithotomy Complications
- ClinicalTrials.gov ID
- NCT05351632
- Acronym / sponsor ID
- 2022/06-7
- Conditions
- Complications, Postoperative
- Keywords
- Comprehensive Complications Index, Percutaneous Nephrolithotomy, Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 644 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Collaborators
- Zonguldak Bulent Ecevit University, Ankara University, Inonu University, Istanbul University, Acibadem University, Eskisehir Osmangazi University, Başakşehir Çam & Sakura City Hospital, Koç University, Izmir Metropolitan Municipality Esrefpasa Hospital, Alanya Alaaddin Keykubat University, Cukurova University, Ondokuz Mayıs University, Dokuz Eylul University, Samsun Education and Research Hospital, Gazi University, Hacettepe University, Abant Izzet Baysal University, Ankara Training and Research Hospital, Hitit University, Baskent University
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Percutaneous kidney stone surgery (PNL) will be performed due to kidney stones, and 644 patients will be included in the study according to the power analysis*. Demographic data of the patients, stone characteristics and data related to stone burden, data related to the operation will be noted by looking at the hospital files. Patients who have undergone surgery can be discharged after an average of 3 days and can be called for routine control after an average of 2 months. All complications developed during the inpatient follow-up and any complications developed during the control period will be noted using the patient's file information. Then, all these complications that are detected to develop will be scored separately using the CCI and CDC complication scales.
- Using the free online tool www.assessurgery.com, the Comprehensive Complications Index (CCI) score for the total burden of complications will be calculated for each patient.
- Each patient's most major complication will be determined and graded according to the Clavien-Dindo (CDC) classification (as described below).
Grade I: Any deviation from the normal postoperative course requiring only the following drugs: antiemetics, antipyretics, diuretics Grade II: Pharmacological therapy (with drugs not necessary for CDC I complications), blood transfusion, total parenteral nutrition Grade IIIa: Surgical, endoscopic or radiological intervention not under general anesthesia Grade IIIb: Surgical, endoscopic or radiological intervention under general anesthesia Grade IVa: single organ dysfunction requiring intensive care unit management Grade IVb: multiple organ dysfunction requiring intensive care unit management Grade V: Death
All the data obtained, CCI and CDC, will be compared among themselves in terms of reliability, demographic data obtained from the pre-operative file data, stone characteristics and data related to the operation will be compared, as well as their relationship with the length of hospital stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient group over 18 years of age with kidney stones and no contraindications for PCNL
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Comprehensive Complication Index
Time frame: within 2 months post-procedure
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.
Clavien-Dindo-Classification score
Time frame: within 2 months post-procedure
The Clavien-Dindo-Classification (CDC), first described in 2004, is the most popular classification system for assessing perioperative morbidity and mortality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reha GİRGİN, Assist.Prof. study director
Zonguldak Bulent Ecevit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complications, Postoperative, run by Marmara University at 1 site in Turkey (Türkiye).
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 3 inclusion and 7 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 28 Apr 2022. 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 Turkey (Türkiye). 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?
Contact Reha GİRGİN, Assist.Prof. (05378865912, mujdereha7477@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Comprehensive Complication Index (time frame: within 2 months post-procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2022.