| CTRI Number |
CTRI/2024/06/068616 [Registered on: 10/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study for different LASERs used for breaking renal stone. |
|
Scientific Title of Study
|
A study of efficacy of Thulium fiber laser vs holmium laser for stone lithotripsy during mini-Percutaneous Nephrolithotomy: Randomized Control 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 |
Venkata Srinadh Gaddam |
| Designation |
Senior resident |
| Affiliation |
Kasturba hospital, manipal |
| Address |
Department of urology,
Kasturba hospital,
manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9494678076 |
| Fax |
|
| Email |
dr.gvsrinadh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunil Pillai Bhaskara |
| Designation |
Professor |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of Urology,
Kasturba Hospital,
Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
08202922242 |
| Fax |
|
| Email |
sunil.pillai@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Arun Kumar Chawla |
| Designation |
Professor |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of Urology,
Kasturba Hospital,
Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
08202922242 |
| Fax |
|
| Email |
arun.chawla@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Urology,
Kasturba Hospital,
Manipal, Udupi |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospital Manipal |
| Address |
Department of Urology,
Kasturba Hospital,
Manipal, Udupi, Karnataka
India - 576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Venkata Srinadh Gaddam |
Kasturba Hospital, Manipal |
Department of Urology,
Kasturba Hospital,
Manipal, Udupi
Udupi
KARNATAKA |
9494678076
dr.gvsrinadh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL 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 |
pcnl with holmium laser |
patients randomized under this arm will undergo pcnl with holmium fiber laser once only for a period of time which is at surgeons discretion. |
| Comparator Agent |
pcnl with holmium laser |
patients randomized under this arm will undergo pcnl with holmium laser once only for a period of time which is at surgeons discretion. |
| Intervention |
pcnl with thulium fiber laser |
patients randomized under this arm will undergo pcnl with thulium fiber laser once only for a period of time which is at surgeons discretion. |
| Comparator Agent |
pcnl with thulium fiber laser |
patients randomized under this arm will undergo pcnl with thulium fiber laser once only for a period of time which is at surgeons discretion. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are undergoing PCNL with stone size ≤ 3cm & who are consenting for the study at the Department of Urology, kasturba Hospital, Manipal |
|
| ExclusionCriteria |
| Details |
Patients opting RIRS, ESWL, Stone size more than three cms and having contra-indications for PCNL like Pregnancy, Infected HUN, Uncorrected Coagulopathy and patients not willing to participate in study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate safety of thulium fiber laser (TFL) and holmium laser for lithotripsy in the miniaturized percutaneous nephrolithotomy (Mini PCNL) for renal stones less than 3cms in terms of stone clearance and complications |
0 - at surgery and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
10/06/2024 |
| 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="1"
Days="1" |
|
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
|
Outcome : To evaluate the effectiveness and safety of thulium fiber laser (TFL) with holmium laser lithotripsy in the miniaturized percutaneous nephrolithotomy (Mini PCNL) for renal stones ≤ 3cms.
The present study will be conducted prospectively in KMCH, Manipal, MAHE, in the Department of Urology. A total of 128 patients will be included, who have renal stones ≤3 cm by CT scan. The type of stone was categorized according to Guy’s stone score. Stone volume was calculated in cubic millimeters by the computed tomography scan software. For multiple stones, all individual stone volumes were added up. Mini PCNL will be performed by the standard method. All the procedures will be done under general anesthesia, in prone position and the puncture by the standard bullseye technique under fluoroscopy guidance and the tract dilatation upto 15-18Fr. The stone will be fragmented using either Ho: YAG or TFL. Randomization will be done using online research randomizer tool (https://www.randomizer.org/). The patients will be assigned to each of the two treatment groups (group I and II). Group I is of patients who will undergo Mini PCNL with stone lithotripsy using Ho: YAG laser and Group II is of patients who will undergo Mini PCNL with stone lithotripsy using a TFL. Ho: YAG laser lithotripsy by a 35-watt machine (Auriga XL 30W, Quanta Systems, Italy). For Ho: YAG laser, the settings range from 0.8–1.2 J energy to 10–15 Hz of frequency. The power levels ranged from 8 to 18 watts. TFL lithotripsy by a 60-watt machine (Urolase SP, IPG Photonics, Russia). The TFL settings range from 0.5 to 1.5 J and 6–15 Hz; total power ranged from 6 to 15 watts. Both lasers will be used with fixed energy settings of 10 watts. The Lasing time will be noted for TFL and Ho: YAG laser. At the end of the procedure, stone clearance will be confirmed nephroscopically and fluoroscopically. The operative time for both the procedures will be noted. The Lasing time will be assessed for both groups. The Lasing time is calculated from the start of laser energy on the stone and till the complete stone was disintegrated. Postoperative care: On follow-up, NCCT KUB will be done after 4 weeks to confirm stone-free status. Residual fragments ≥ 4 mm was considered as significant. |