Complication,PostoperativeNCT05593783
The Use of the "Comprehensive Complication Index" for Urinary Lithiasis Surgery.
An observational study of Complication,Postoperative and Lithiasis, Urinary, run by Sismanoglio General Hospital at 1 site in Greece.
Trial summary
The study will be prospective non-interventional and will include patients with kidney stones who are to undergo one of the following three techniques: retrograde nephrolithotripsy, percutaneous nephrolithotripsy and extracorporeal nephrolithotripsy depending on the size of the stone. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complication,Postoperative, Lithiasis, Urinary
- What is being tested?
- lithotripsy
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteGreece
- Study dates
- 21 Oct 2022to 30 Jun 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with lithiasis
Who may be able to join
- Patients with urinary lithiasis undergoing ureterolithotripsy, percutaneous nephrolithotripsy or extracorporeal shockwave lithotripsy.
Who cannot join
- 1. Non-acceptance by the patient of his participation or inability to understand the purposes and procedures of the study.
- 2. Recent similar operation that the patient has undergone (interval of less than one month).
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Sismanoglio General Hospital
Athens, Marousi, 15126
Charalambos Deliveliotis, 2132058, ourologiki@sismanoglio.gr
About this study
Official title: The Use of the "Comprehensive Complication Index" as a Recording System of Postoperative Complications After Percutaneous, Retrograde and Extracorporeal Lithotripsy for Renal Lithiasis.
The study will be prospective non-interventional and will include patients with kidney stones who are to undergo one of the following three techniques: retrograde nephrolithotripsy, percutaneous nephrolithotripsy and extracorporeal nephrolithotripsy depending on the size of the stone. Data regarding post operative descriptions will be recorded and comprehensive complication index will be used for the assesment of the burden.
Read the detailed description
The study will be prospective non-interventional and will include patients with kidney stones who are to undergo one of the following three techniques: retrograde nephrolithotripsy, percutaneous nephrolithotripsy and extracorporeal nephrolithotripsy depending on the size of the stone. The study will take place at the 2nd Urology Clinic of the University of Athens, at the Sismanoglio Hospital of Athens. It will include patients diagnosed with kidney stones after plain X-ray and/or CT scan. Percutaneous nephrolithotripsy will be performed on stones > 2 cm, while extracorporeal or retrograde nephrolithotripsy on stones < 2 cm. Patient demographics (age, gender, body mass index, comorbidities, anticoagulant use), stone-related data (maximum stone size, anatomic location of stone, number of stones, presence of hydronephrosis preoperatively, presence of piglet catheter preoperatively, positive urine culture, preoperative chemoprophylaxis ) as well as information about the operation (type of anesthesia, operation time, hospitalization time) will be reported. Finally, all possible complications will be recorded intraoperatively, immediately postoperatively and up to 30 days after the day of surgery. This will be followed by a statistical analysis of the resulting data and a comparison between the CDC and CCI systems using the SPSS statistical program. To describe continuous variables, the mean/standard deviation will be used if it is a normal distribution, or the median and range if it is a non-normal distribution. The Shapiro-Wilk test will be used to investigate the distribution of the data. The absolute number and the corresponding percentage will be used to describe the qualitative variables. For the comparison of continuous variables, the parametric t-test will be used if the data follow a normal distribution, or the Mann-Whitney U test if they do not follow a normal distribution. Chi-square and Fisher's exact test will be used to compare qualitative variables. Exclusion criteria from this study are:
- Non-acceptance by the patient of his participation or inability to understand the purposes and procedures of the study.
- Recent similar operation that the patient has undergone (interval of less than one month).
- Conditions
- Complication,Postoperative, Lithiasis, Urinary
- Being tested
- lithotripsy
- Keywords
- clavien dindo, urinary lithiasis, endourology, complications
- Medical subject headings
- Postoperative Complications, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lithotripsyProcedure or surgery
Also called percutaneous nephrolithotomy, extracorporeal shockwave lithotripsy
lithotripsy
| Study group | Role | What they receive |
|---|---|---|
| patients with lithiasis treated with ureterolithotripsy | patients with lithiasis treated with ureterolithotripsy Receives: Procedure: lithotripsy | |
| patients with lithiasis treated with percutaneous nephrolithotomy | patients with lithiasis treated with percutaneous nephrolithotomy Receives: Procedure: lithotripsy | |
| patients with lithiasis treated with extracorporeal shockwave lithotripsy | patients with lithiasis treated with extracorporeal shockwave lithotripsy Receives: Procedure: lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
comprehensive complication index score
reporting postoperative complications with clavien dindo and comprehensive complication index and comparison of those two.
Measured: 1,5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start21 Oct 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication,PostoperativeStudies of the same condition, open and under way.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sismanoglio General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stamatios Katsimperis, Sismanoglio General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593783
- Sponsor's protocol ID
- 67127
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2022
- Last updated
- 25 Oct 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 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the "Comprehensive Complication Index" as a Recording System of Postoperative Complications After Percutaneous, Retrograde and Extracorporeal Lithotripsy for Renal Lithiasis.
- ClinicalTrials.gov ID
- NCT05593783
- Acronym / sponsor ID
- 67127
- Conditions
- Complication,Postoperative, Lithiasis, Urinary
- Keywords
- clavien dindo, urinary lithiasis, endourology, complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Sismanoglio General HospitalUniversity, hospital or other
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 25 Oct 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.
The study will be prospective non-interventional and will include patients with kidney stones who are to undergo one of the following three techniques: retrograde nephrolithotripsy, percutaneous nephrolithotripsy and extracorporeal nephrolithotripsy depending on the size of the stone. Data regarding post operative descriptions will be recorded and comprehensive complication index will be used for the assesment of the burden.
Detailed description
The study will be prospective non-interventional and will include patients with kidney stones who are to undergo one of the following three techniques: retrograde nephrolithotripsy, percutaneous nephrolithotripsy and extracorporeal nephrolithotripsy depending on the size of the stone. The study will take place at the 2nd Urology Clinic of the University of Athens, at the Sismanoglio Hospital of Athens. It will include patients diagnosed with kidney stones after plain X-ray and/or CT scan. Percutaneous nephrolithotripsy will be performed on stones > 2 cm, while extracorporeal or retrograde nephrolithotripsy on stones < 2 cm. Patient demographics (age, gender, body mass index, comorbidities, anticoagulant use), stone-related data (maximum stone size, anatomic location of stone, number of stones, presence of hydronephrosis preoperatively, presence of piglet catheter preoperatively, positive urine culture, preoperative chemoprophylaxis ) as well as information about the operation (type of anesthesia, operation time, hospitalization time) will be reported. Finally, all possible complications will be recorded intraoperatively, immediately postoperatively and up to 30 days after the day of surgery. This will be followed by a statistical analysis of the resulting data and a comparison between the CDC and CCI systems using the SPSS statistical program. To describe continuous variables, the mean/standard deviation will be used if it is a normal distribution, or the median and range if it is a non-normal distribution. The Shapiro-Wilk test will be used to investigate the distribution of the data. The absolute number and the corresponding percentage will be used to describe the qualitative variables. For the comparison of continuous variables, the parametric t-test will be used if the data follow a normal distribution, or the Mann-Whitney U test if they do not follow a normal distribution. Chi-square and Fisher's exact test will be used to compare qualitative variables. Exclusion criteria from this study are:
- Non-acceptance by the patient of his participation or inability to understand the purposes and procedures of the study.
- Recent similar operation that the patient has undergone (interval of less than one month).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with lithiasis treated with ureterolithotripsy | – | Procedure: lithotripsypatients with lithiasis treated with ureterolithotripsy |
| patients with lithiasis treated with percutaneous nephrolithotomy | – | Procedure: lithotripsypatients with lithiasis treated with percutaneous nephrolithotomy |
| patients with lithiasis treated with extracorporeal shockwave lithotripsy | – | Procedure: lithotripsypatients with lithiasis treated with extracorporeal shockwave lithotripsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with lithiasis
Key inclusion criteria (1 listed)
- Patients with urinary lithiasis undergoing ureterolithotripsy, percutaneous nephrolithotripsy or extracorporeal shockwave lithotripsy.
Key exclusion criteria (2 listed)
- 1. Non-acceptance by the patient of his participation or inability to understand the purposes and procedures of the study.
- 2. Recent similar operation that the patient has undergone (interval of less than one month).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lithotripsyAlso: percutaneous nephrolithotomy, extracorporeal shockwave lithotripsylithotripsy | Procedure or surgery | patients with lithiasis treated with extracorporeal shockwave lithotripsy, patients with lithiasis treated with percutaneous nephrolithotomy, patients with lithiasis treated with ureterolithotripsy |
Primary outcome
comprehensive complication index score
Time frame: 1,5 year
reporting postoperative complications with clavien dindo and comprehensive complication index and comparison of those two.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 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.
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 Complication,Postoperative and Lithiasis, Urinary, run by Sismanoglio General Hospital at 1 site in Greece.
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 1 inclusion and 2 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 25 Oct 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 Greece. 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 Charalambos M Deliveliotos, MD (23102058369, ourologiki@sismanoglio.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comprehensive complication index score (time frame: 1,5 year). 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 25 Oct 2022.