Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05593783 |
| Other study ID # |
67127 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 21, 2022 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
October 2022 |
| Source |
Sismanoglio General Hospital |
| Contact |
Charalambos M Deliveliotos, MD |
| Phone |
23102058369 |
| Email |
ourologiki[@]sismanoglio.gr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. Data regarding post operative descriptions will be recorded and comprehensive
complication index will be used for the assesment of the burden.
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:
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).
