| CTRI Number |
CTRI/2023/03/050827 [Registered on: 20/03/2023] Trial Registered Prospectively |
| Last Modified On: |
18/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical Trial to compare
dusting versus fragmentation
using Thulium Fibre Laser in
flexible ureteroscopy |
|
Scientific Title of Study
|
Prospective Randomised
Controlled Trial to compare
dusting versus fragmentation
using Thulium Fibre Laser in
RIRS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nishanth S |
| Designation |
Urology Resident |
| Affiliation |
Muljibhai Patel Urological Hospital |
| Address |
Urology Resident, Muljibhai Patel urological hospital.
Dr Virendra Desai road.
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
09632394780 |
| Fax |
|
| Email |
nishanthinmmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arvind Ganpule |
| Designation |
Consultant urologist and Vice Chairman |
| Affiliation |
Muljibhai Patel Urological Hospital |
| Address |
Muljibhai Patel urological hospital.
Dr Virendra Desai road.
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9824188685 |
| Fax |
|
| Email |
doctorarvind1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nishanth S |
| Designation |
Urology Resident |
| Affiliation |
Muljibhai Patel Urological Hospital |
| Address |
Urology Resident, Muljibhai Patel urological hospital.
Dr Virendra Desai road.
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
09632394780 |
| Fax |
|
| Email |
nishanthinmmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Muljibhai Patel Urological Hospital, Nadiad |
|
|
Primary Sponsor
|
| Name |
Muljibhai Patel Urological hospital |
| Address |
Dr Virendra Desai Road
Nadiad |
| 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 |
| Nishanth S |
Muljibhai Patel Urological Hospital |
Operation theatre, Urology division.
Kheda
GUJARAT |
9632394780
nishanthinmmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muljibhai Patel Society For Research in Nephro-Urology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dusting and fragmentation both are compared |
The present study was conducted to compare two techniques of thulium
laser lithotripsy (dusting and spontaneous passage with fragmentation)
during fURS for renal stones.
Duration is till whole stone is cleared. |
| Intervention |
RIRS |
The present study was conducted to compare two techniques of thulium laser lithotripsy (dusting and spontaneous passage with fragmentation) during fURS for renal stones. Duration is till whole stone is cleared. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Renal stone 1-1.5 cm in size.
Upper ureteral stone less than 1.5 cm in size. |
|
| ExclusionCriteria |
| Details |
Active UTI.
Incomplete procedure due to technical error/malfunction.
Previous endoscopic intervention.
Ineligible patient for RIRS.
Patient not consenting |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stone free rate |
at Post op day 1 and at 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean operating time.
Hospital stay duration.
Complication rate.
Need for secondary procedures. |
During surgery and at 1 month of follow up |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
21/03/2023 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Thulium laser lithotripters allow the urologist to control laser settings (energy and frequency) to adjust the power that is delivered at the tip of the laser fibre.
Low energy, high frequency lithotripsy results in tiny fragment sizes that can pass spontaneously, and this technique has been termed ‘dusting’.
On the other hand, higher energy levels with lower frequencies results in fragments that require active retrieval with baskets and this technique has been termed ‘fragmentation’.
The widespread use of thulium laser lithotripsy has created debates about the best laser lithotripter settings.
A few studies have compared fragmentation and active retrieval with dusting and spontaneous passage for renal stones, and the laser settings were not mentioned in one of them.
The present study was conducted to compare two techniques of thulium laser lithotripsy (dusting and spontaneous passage with fragmentation) during fURS for renal stones. |