| CTRI Number |
CTRI/2024/12/078523 [Registered on: 24/12/2024] Trial Registered Prospectively |
| Last Modified On: |
16/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Efficacy of Retrograde Intrarenal Surgery versus Supine Percutaneous Nephrolithotomy for 1–2 cm Kidney Stones |
|
Scientific Title of Study
|
Comparative analysis of Efficacy of Retrograde Intrarenal Surgery (RIRS) versus Supine Percutaneous Nephrolithotomy (PCNL) for Renal Pelvic Stone 1-2 cm: Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arvind Kumar |
| Designation |
Academic Senior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Department of Urology
AIIMS Patna
Patna
BIHAR
801505
India |
| Phone |
8057657441 |
| Fax |
|
| Email |
arvind5892@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamlesh Gunjan |
| Designation |
Associate Professor and Head |
| Affiliation |
AIIMS Patna |
| Address |
Department of Urology
AIIMS Patna
Patna
BIHAR
801505
India |
| Phone |
8130412247 |
| Fax |
|
| Email |
drkamleshg@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Kumar |
| Designation |
Academic Senior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Department of Urology
AIIMS Patna
Patna
BIHAR
801505
India |
| Phone |
8057657441 |
| Fax |
|
| Email |
arvind5892@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Patna,Phulwarisharif, Patna, Bihar-801507, India |
|
|
Primary Sponsor
|
| Name |
AIIMS PATNA |
| Address |
Phulwarisharif, Patna, Bihar-801507, India |
| 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 Arvind Kumar |
AIIMS Patna |
Department of Urology, AIIMS Patna
OPD block,
room no. 345
Phulwarisharif, Patna, Bihar-801507, India
Patna
BIHAR |
8057657441
arvind5892@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,All India Institute of Medical Sciences Patna |
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 |
Retrograde Intrarenal Surgery (RIRS) |
Retrograde Intrarenal Surgery (RIRS) is a minimally invasive procedure to remove kidney stones using a flexible fiberoptic endoscope and laser.In post operative period stone free rate will be noted for comparison. |
| Comparator Agent |
Supine Percutaneous Nephrolithotomy (PCNL) |
Supine Percutaneous Nephrolithotomy (PCNL) is a minimally invasive procedure to remove kidney stones. The patient lies on their back, and a small incision is made to insert a nephroscope. Stones are fragmented using energy sources like ultrasound or laser, then removed. In post operative period stone free rate will be noted for comparison. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with symptomatic renal stones (causing pain, bleeding, or obstruction) confirmed by imaging (CT scan, ultrasound)
2.Stone size 1-2 cm in diameter on largest dimension
3.Age 18 years or older
4.Able to provide informed consent and willing to undergo randomization
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.Active uncontrolled bleeding disorder
3.Uncontrolled systemic infection/urinary tract infection
4.Previous open renal surgery on the affected kidney
5.Physical attributes that significantly hinder access during RIRS or PCNL (e.g., severe ureteral angulation)
6.Inability to tolerate general anaesthesia (for Supine PCNL)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the stone-free rates of retrograde intrarenal surgery versus supine PCNL |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Average duration each surgery.
2.Fall in haematocrit.
3.VAS for pain.
4.Hospital Stay
5.Complication grading according to Clavien Dindo classification. |
post operative day 1,
Post operative at the time of dischage |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/12/2024 |
| 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="6"
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
|
Aim: The aim of this study is to compare SFR of Retrograde Intrarenal Surgery (RIRS) and Supine Percutaneous Nephrolithotomy (PCNL). Purpose: 1. This study fills a gap in the current literature by directly comparing Retrograde Intrarenal Surgery (RIRS) and Supine Percutaneous Nephrolithotomy (PCNL) for the management of renal pelvic stones measuring 1-2 cm. 2. Prior research has primarily concentrated on either of the two techniques individually or in diverse groups of patients, but none have thoroughly examined both treatments within this stone size category using a randomised controlled trial (RCT) design Research hypothesis: RIRS have no difference in SFR to Supine PCNL for managing renal stones 1-2 cm.
Objectives: 1. Primary objective: To compare the stone-free rates achieved by Retrograde Intrarenal Surgery (RIRS) and Supine Percutaneous Nephrolithotomy (PCNL) for treating kidney stones 1-2 cm in maximum diameter 2. Secondary objective(s): 1.Average duration each surgery. 2.Fall in haematocrit. 3.VAS for pain. 4.Hospital Stay - Complications according to Clavien Dindo clasiification.
|