|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
15 April 2024 |
|
Main ID: |
ISRCTN55546280 |
|
Date of registration:
|
16/02/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
The role of surgical treatment on lower pole renal stones
|
|
Scientific title:
|
A prospective randomized comparison among shock wave lithotripsy, percutaneous lithotripsy and retrograde intrarenal surgery for lower calyceal stones less than 2 cm: a multicenter experience |
|
Date of first enrolment:
|
01/01/2010 |
|
Target sample size:
|
176 |
|
Recruitment status: |
Completed |
|
URL:
|
https://www.isrctn.com/ISRCTN55546280 |
|
Study type:
|
Interventional |
|
Study design:
|
Multicenter randomized unblinded clinical trial (Treatment)
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Austria
|
England
|
Italy
|
Russian Federation
|
United Kingdom
| | | |
|
Contacts
|
|
Name:
|
Giorgio
Bozzini |
|
Address:
|
via Gerenzano 2
21053
Castellanza
Italy |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. Consecutive patients with a single LP stone with a diameter of 1 to 2 cm as measured at CT scan, that received the indication of active removal according to EAU Guidelines
2. Age between 18 and 75 years
Exclusion criteria: 1. Presence of coagulation disorders
2. Age under 18 or over 75 years
3. Presence of acute infection (fever more than 38° C or total leucocyte count more than 15000/dl)
4. Presence of solitary kidney
5. Coexisting ureteric disease (tumour or stricture)
6. Pregnancy
7. Presence of cardiovascular or pulmonary comorbidities
8. Multiple stones
9. Steep infundibolar-pelvic angle (< 30°)
10. Longer calyx more than 10 mm
11. Narrow infundibulum (less than 5 mm) as demonstrated by contrast enhanced CT
12. Patients who refuse to give consent to the study
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Renal lower calyceal stones
Urological and Genital Diseases
|
|
Intervention(s)
|
Patients will be randomized into three groups:
Group A: SWL
Group B: RIRS
Group C: PCNL
The randomization allocation sequence will be produced with the online free Random Allocation Software (M. Saghaei, MD). The principal investigator for each center will enroll and assign participants to groups. The randomization will be stratified by center. Each center will use their own equipment to perform treatments, but the procedures will be standardized and were supervised by an experienced surgeon in the field of stone management.
SWL will be performed with ultrasound or x-ray guided targeting of the stone with a frequency of 100 impulses/min and a maximum of 2500 shock waves (SW) per session. Patients will be observed for at least two hours after the SWL and then discharged as an outpatient procedure.
RIRS will be performed with a flexible ureteroscope and a 30 W Holmium YAG Laser device. Before the sheath insertion, an ureteric dilatation will be performed when required. Bigger fragments will be removed with a stone retrieval basket. After the procedure a double J stent will be inserted in all patients and its removal will be planned after 4 weeks if the patient will be stone free.
PCNL will be performed with a rigid nephroscope 20.8 to 24 Fr. and a 30 W Holmium YAG Laser device. PCNL will be performed with the patient either in prone or modified supine position according to the operator’s preference. The kidney puncture will be performed under fluoroscopic and/or US guidance. Calyx will be cleaned removing bigger fragments with a stone retrieval basket. Each patient will have a nephrostomy tube placement after the procedure removed after two days if urine is clear.
A stone analysis will be performed in all cases, when fragments available. Patients affected by uric ac
|
|
Primary Outcome(s)
|
|
Stone-free rate (SFR), defined as a negative CT scan or an asymptomatic patient with stone fragments less than 3 mm and a negative urine culture, measured at 3 months
|
|
Secondary Outcome(s)
|
|
Peri- and post-operative complications of procedures, classified using the validated Dindo-modified Clavien System, during the hospitalization and until 3 months
|
|
Secondary ID(s)
|
|
2009-001328-14
|
|
77/gb/2009
|
|
Source(s) of Monetary Support
|
|
European Association of Urology
|
|
Ethics review
|
Status:
Approval date:
Contact:
Old ethics approval format; ASL Milano 2, 12/03/2009, ref: 2009/2388/DU
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
31/12/2014 |
|
URL:
|
|
|
|