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CTRI Number  CTRI/2024/07/071618 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
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 to compare stone free rate using suction versus conventional ureteral access sheath in retrograde intrarenal surgery for nephrolithiasis 
Scientific Title of Study   Comparative efficacy of suction versus conventional ureteral access sheath in achieving stone free status in retrograde intrarenal surgery: A 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 Robal Lacoul 
Designation  MCh Resident 
Affiliation  Maharajgunj Medical Campus, Institute of Medicine, Tribhuvan University 
Address  Department of Urology and Kidney transplant surgery, Maharajgunj Medical Campus,Institue of Medicine, Kathmandu

Not Applicable
N/A
44600
Other 
Phone  9849193029  
Fax    
Email  drlacoul@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pawan Raj Chalise 
Designation  Associate Professor and Guide 
Affiliation  Maharajgunj Medical Campus, Institute of Medicine 
Address  Department of Urology and Kidney transplant surgery, Maharajgunj Medical Campus,Institue of Medicine, Kathmandu

Not Applicable
N/A
44600
Other 
Phone  9851067980  
Fax    
Email  pawan_rc@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Pawan Raj Chalise 
Designation  Associate Professor and Guide 
Affiliation  Maharajgunj Medical Campus, Institute of Medicine 
Address  Department of Urology and Kidney transplant surgery, Maharajgunj Medical Campus,Institue of Medicine, Kathmandu

Not Applicable
N/A
44600
Other 
Phone  9851067980  
Fax    
Email  pawan_rc@yahoo.com  
 
Source of Monetary or Material Support  
Department of Urology and Kidney transplant surgery, Maharajgunj Medical Campus,Institue of Medicine, Kathmandu, Postal code: 44600 
 
Primary Sponsor  
Name  Dr Robal Lacoul 
Address  Department of Urology and Kidney transplant surgery, Maharajgunj Medical Campus,Institue of Medicine, Kathmandu,Postalcode: 44600 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Pawan Raj Chalise  Institute of Medicine, Maharajgunj Medical Campus, Tribhuvan University 
 
Countries of Recruitment     Nepal  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Robal Lacoul  Maharajgunj Medical Campus, Institute of Medicine  Department of Urology and Kidney transplant surgery, Kathmandu

 		 9849193029

drlacoul@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Insitutional Review Committee, Institute of Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional ureteric access sheath (cUAS)  i)Use of 10/12 Fr conventional ureteric access sheath (U-FLEX, allwin® Medical Devices) into the ureter till renal pelvis ii)7.5Fr digital flexible digital ureteroscope (bioradmedisysTM, India) advanced over the cUAS iii)Stones fragmented using Thulium fiber laser (TFL) (Quanta System S.p.A., Italy) with a 200 μm laser fiber with energy setting of 400-500mJ; frequency 15-30Hz; 12–16W iv)6Fr double-J stent (DEVON®, India) routinely placed 
Comparator Agent  Suction ureteric access sheath (sUAS)  i)Use of 10/12Fr suction ureteral access sheath (V-UAS, ClearPetra®, Well Lead Medical, China) into the ureter till renal pelvis ii)7.5Fr digital flexible digital ureteroscope (bioradmedisysTM, India) advanced over the cUAS iii)Negative suction pressure set to 3–8 kPa iv)Stones fragmented using Thulium fiber laser (TFL) (Quanta System S.p.A., Italy) with a 200 μm laser fiber with energy setting of 400-500mJ; frequency 15-30Hz; 12–16W v)6Fr double-J stent (DEVON®, India) routinely placed 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All patients with symptomatic renal stones undergoing retrograde intrarenal surgery (RIRS) with renal stone less than 2cm in any location 
 
ExclusionCriteria 
Details  i)Age less than 18yrs
ii)Congenital anomalous kidney (Horseshoe kidney, Ectopic kidney, Crossed fused renal ectopia)
iii)History of previous ureteric injury and ureteric reconstruction or known ureteric anomalies (Duplex collecting system)
iv)Undergoing endoscopic combined intra renal surgery
v)Need for conversion to PCNL intra-operatively
vi)Bilateral same sitting RIRS
vii)Previous ureteric injury or known ureteric anomalies or past ureteric reconstruction
viii)Patients with known chronic renal failure on renal replacement therapy
ix)Need to abandon surgery intra-operatively due to non-technical reasons 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
to compare stone free rate between use of conventional and suction ureteric access sheath  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
to compare complications  2 weeks 
to compare need of re-intervention  1 month 
to compare operative time  1 day 
to compare stone free status   1 day 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/08/2024 
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 Yet Recruiting 
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  

Retrograde Intrarenal Surgery (RIRS) is first-line surgical treatment with good stone-free rate (SFR) for renal stones ≤20mm. Newer suction ureteral access sheath has been reported to have additional advantage of improved SFR with decreased complications as compared to conventional RIRS. This study aims to identify if suction RIRS is safe and efficacious in the treatment of nephrolithiasis.

This is a hospital based comparative study. All the patients undergoing RIRS at department of urology and kidney transplant surgery will be eligible for study. Patients will be divided into suction and conventional RIRS by simple random sampling and comparison of various intraoperative and post-operative parameters will be done to assess the safety and efficacy of suction RIRS.

 
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