| CTRI Number |
CTRI/2025/04/085267 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two surgical modalities for treating kidney stones in children |
|
Scientific Title of Study
|
A Prospective Randomized Controlled Trial Comparing Mini Percutaneous
Nephrolithotomy Vs Retrograde Intra Renal Surgery in Moderate Sized (10-20mm) Pediatric Renal Stones
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arshad Khan |
| Designation |
Senior Resident MCh Urology |
| Affiliation |
PGIMER , CHANDIGARH |
| Address |
Advanced Urology Centre (26) First Floor, Level 2 Nehru Hospital,
Post graduate institute of medical education and research(PGIMER)
CHANDIGARH,160012
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9827207186 |
| Fax |
|
| Email |
dr.arshad.dots@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudheer Kumar Devana |
| Designation |
Additional Professor |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Advanced Urology Centre (26) First Floor, Level 2 Nehru Hospital,
Post graduate institute of medical education and research
Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855509868 |
| Fax |
|
| Email |
drsudheer1983@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arshad Khan |
| Designation |
Senior Resident MCh Urology |
| Affiliation |
PGIMER CHANDIGARH |
| Address |
Advanced Urology Centre (26) First Floor, Level 2 Nehru Hospital,
Post graduate institute of medical education and research(PGIMER)
CHANDIGARH,160012
Chandigarh
CHANDIGARH
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9827207186 |
| Fax |
|
| Email |
dr.arshad.dots@gmail.com |
|
|
Source of Monetary or Material Support
|
| Urology department (AUC-26) Level II , First Floor, Nehru Hospital Post graduate institute of
medical education and research Chandigarh, Sector-12 160012 |
|
|
Primary Sponsor
|
| Name |
Post graduate institute of medical education and research Chandigarh |
| Address |
Madhya Marg Nehru Hospital Level II , First Floor Post Graduate
Institute of Medical Education and Research Chandigarh, Sector 12
160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arshad Khan |
Nehru Hospital (Post Graduate Institute of Medical Education and Research) |
Advanced Urology
Centre (26), Urology
Office , LEVEL II, Nehru
Hospital, Post Graduate
Institute of Medical
Education and
Research,Madhya
Marg,
CHANDIGARH,160012
Chandigarh
CHANDIGARH
Chandigarh
CHANDIGARH |
9827207186
dr.arshad.dots@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mini PCNL |
After general anaesthesisa , a uretric catheter wll be placed into the renal pelvis after placing the child in lithotomy position.In children less than 5 years old a 4 Fr uretric catheter and in children more than 5 years old a 5 Fr uretric catheter will be placed using 0.018 inch toremo guide wire.In prone position under fluoroscopy target calyx was punctured using 18 gauge diamond tip trocar needle.Then a straight tip 0.032 inch toremo guide wire will be placed in PCS. tract dilated upto 17.5 Fr using fascial and metal dilators gradually.Karl storz 12Fr mini PCNL nephroscope used to clear stones.Holmium YAG laser used to dust or fragmaent the stones.Residual stones are cleared using alligater forcep or by vacuum cleaning effect.After confirming endoscopic and fluoroscopic stone clearance decision to place 12 fr nephrostomy and DJ stent to be taken by operating urologist.Operative details like type of puncture , lasing time , total operative time , post operative complications and hospital stay will be recorded. |
| Comparator Agent |
RIRS |
After general anaesthesia the child will be placed in lithotomy position. 0.032 inch guide wire placed in ipsilateral ureter and using 4.5/6 Fr semirigid uretroscope , uretroscopy done.If ureter is capacious enough to allow uretric access sheath(UAS) ,it is placed just below pelvi uretric junction.If ureter is not capacious than appropriate size DJ stent is placed to dilate it , after 2 to 3 weeks of stent placement a repaet RIRS will be attemted.A fibreoptic/digital flexible uretrorenoscope will be introduced into the UAS till the pelvicalyceal system and renal calculus visualised.If placement of UAS fails , direct placement of flexible uretrorenoscope over guide wire attempted and if successful procedare performed without UAS.How ever if placing flexible uretrorenoscope fails even after DJ stent placement then over all procedure will be converted to mini PCNL.
RIRS will be performed using manual 50 ml syringe pumps a line irrigation. The stone will be ablated using Holmium YAG laser using 200 micron laser fiber(30 W , QUANTA LITHO).The stone is dusted/fragmented and residue removed using basket.Total procedure time and lasing time noted seoarately.At end of procedure appropriate size DJ stent and per urethral catheter placed in all children. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
a) Parents of children who opt for either mini PCNL or RIRS
b) Parents willing to give the consent to be a part of the study.
|
|
| ExclusionCriteria |
| Details |
a) Children who were considered for ESWL
b) Active urinary tract infection (UTI)
c) Renal malformation like horseshoe kidney, ectopic kidney, mal rotated kidney
d) Presence of spine abnormalities like scoliosis/ kyphosis
h) Presence of associated ureteric calculus
i) Bilateral stone surgery is planned simultaneously
e) Uncorrected coagulopathy
f) Presence of ureteric stricture
g) Presence of urethral stricture |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare stone free rate in mini PCNL and RIRS in management of moderate sized renal stones (10-20mm) in children at 1 month following surgery. |
1 month after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare 30-day major clavien dindo (class II-V) complication rate following mini PCNL and RIRS in management of moderate sized renal stones (10-20mm) in children.
2) To compare other variables like operative time (OT) and hospital stay mini PCNL and RIRS in management of moderate sized renal stones (10-20mm) in children.
3) To compare emergency readmission rate till 30 day following surgery in mini PCNL and RIRS groups.
|
1 month after surgery. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a prospective double blinded , parallel group , single center randomized controlled trial comparing mini pecutaneous nephrolithoyomy (Mini PCNL) vs retrograde intra renal surgery ((RIRS) in moderate sized (10-20mm) pediatric renal stones with primary objective to compare stone free rate following 1month after surgery in each arm of Mini PCNL and RIRS .The secondary objective is to compare 30 day major clavien dindo ( class I and V) complications , operative time , duration of hospital stay , emergency readmision rate till 30 day following surgery. |