| CTRI Number |
CTRI/2021/05/033628 [Registered on: 17/05/2021] Trial Registered Prospectively |
| Last Modified On: |
13/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of miniperc with suction and miniperc without suction for treatment of Kidney Stones |
|
Scientific Title of Study
|
Prospective, randomized, study comparing miniperc with suction and miniperc without suction for treatment of Kidney Stones |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ravnidra sabnis |
| Designation |
Head of the department |
| Affiliation |
MPUH |
| Address |
Department of Urology,
MPUH Nadiad,
VV Desai Road,
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9426422002 |
| Fax |
|
| Email |
rbsabnis@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravidra Sabnis |
| Designation |
HOD |
| Affiliation |
MPUH |
| Address |
Dept of Urology,
MPUH Nadiad,
VV Desai road,
Nadiad
Kheda
GUJARAT
38700
India |
| Phone |
9426422002 |
| Fax |
|
| Email |
rbsabnis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rb Sabnis |
| Designation |
Head of the department |
| Affiliation |
MPUH |
| Address |
Dept of Urology,
MPUH Nadiad,
VV Desai road,
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9426422002 |
| Fax |
|
| Email |
rbsabnis@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
muljibhai urology hospital |
| Address |
MPUH
VV Desai Road |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Aditya Parikh |
MPUH |
Department of Urology,
MPUH, Nadiad,
VV Desai Road
387001
Kheda
GUJARAT |
09825061790
adityaparikh26@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: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Addition of suction sheath to miniperc |
The intervention will be for duration of the surgery only.Addition of suction sheath to miniperc is believed to increase speed and stone clearance rate |
| Comparator Agent |
Standarad miniperc with a miniperc sheath |
This is the standarad of care and is well established procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All PCNL for stones <2.5 cm in maximum dimension will be included in the study |
|
| ExclusionCriteria |
| Details |
BMI> 35
Paediatric population
bleeding diathesis
Any patient with a urinary tract infection was treated before the procedure with intravenous antibiotics till urine culture was sterile.
Female subjects who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test;
Presence of abnormal upper tract anatomy that makes access difficult
Presence of untreated UTI
Inability to give consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fragementation rate and operative time |
Intraoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Stone free rate
2. Complication rate
3. Total energy used
|
Intraopearatively, day 0, day of discharge, 1 month 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)
|
17/05/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Miniperc is a standarad of care for renal stones that are small to medium in size. The addition of suction to miniperc is established to be safe. However a randomised trial comparing the two modalities with respect to operative time is lacking. this trial fills in that missing link |