| CTRI Number |
CTRI/2023/03/050494 [Registered on: 09/03/2023] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Trial comparing infectious complications with and without the use of suction in mini PCNL for kidney stones |
|
Scientific Title of Study
|
A randomised controlled trial comparing infectious complications using mini perc with and without suction for renal stones less than 3 cm in size |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Desai |
| Designation |
Urologist |
| Affiliation |
Muljibhai Patel Urological Hospital |
| Address |
Ground Floor
Uro Office
Urology Department
Muljibhai Patel Urological Hospital,
Off VV Desai Road,
Nadiad.
Gujarat. India.
Kheda
GUJARAT
387001
India |
| Phone |
|
| Fax |
|
| Email |
mrdesai@mpuh.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niramya Pathak |
| Designation |
Urologist |
| Affiliation |
Muljibhai Patel Urological Hospital |
| Address |
Urology OPD
First Floor
Urology Department
Muljibhai Patel Urological Hospital,
Off VV Desai Road,
Nadiad.
Gujarat. India.
Kheda
GUJARAT
387001
India |
| Phone |
|
| Fax |
|
| Email |
niramya.pathak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niramya Pathak |
| Designation |
Urologist |
| Affiliation |
Muljibhai Patel Urological Hospital |
| Address |
Urology OPD
First Floor
Urology Department
Muljibhai Patel Urological Hospital,
Off VV Desai Road,
Nadiad.
Gujarat. India.
Kheda
GUJARAT
387001
India |
| Phone |
|
| Fax |
|
| Email |
niramya.pathak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Muljibhai Patel Urological Hospital |
|
|
Primary Sponsor
|
| Name |
Muljibhai Patel Urological Hospital |
| Address |
Muljibhai Patel Urological Hospital, Off VV Desai Road, Nadiad, Gujarat. 387001 |
| 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 Niramya Pathak |
Muljibhai Patel Urological Hospital |
Urology OPD. First Floor.
Urology Department
Kheda
GUJARAT |
9428503526
niramya.pathak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muljibhai Patel Society for Research in Nephro-Urology Ethics Committee |
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 |
Mini PCNL without suction |
Mini PCNL procedure is done as per standard steps wwithout any suction
Duration of study is 6 months |
| Intervention |
Suction with mini PCNL |
mini PCNL with and without suction for renal stones are compared. The assumption is that use of suction in mini PCNL reduces intra renal pressures and reduces the incidence of postoperative sepsis
Duration of study is 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Renal stones less than 3 cm and planned for mini PCNL |
|
| ExclusionCriteria |
| Details |
Patient not willing
Patient not consenting
Patient not fitting in inclusion criteria
Renal anatomical abnormalities
Active UTI
Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post procedure Infection (fever, sepsis) |
72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| stone free rate |
30 days |
| Post operative complications |
72 hours |
| Operating times |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/03/2023 |
| 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="6"
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
|
Tract size between 14-22 Fr is called as mini-PCNL. This was first introduced in the year 2001 and since then various modifications have been made to the equipment. Miniaturization of PCNL sheath decreases morbidity to the patient. There is a decrease in blood loss with maintained stone-free rates along with a lesser need for blood transfusion. There is greater manoeuvrability of the miniaturised sheath in the pelvicalyceal system as well as less requirement of placement of nephrostomy tube in mini-PCNL. There is an additional benefit that the smaller dust particles are also extracted leaving behind little chance of a residual fragments. The use of suction sheath in Mini-PCNL was introduced with the rationale that it decreases intra-renal pressure, makes stone extraction more efficient and provides better vision due to lesser “dust-storm†formation Superperc was a terminology that was initially used with a 10-14 Fr suction sheath but the subsequent generation sheaths are available up to 21 Fr and the use of the term is not restricted to sheath size For large size of stone there have been studies that have proved the superiority of using suction sheath by decreasing operating time and increasing the stone-free rate. There is evidence to support the use of suction sheath in the presence of pyonephrosis. However there is a gap in the knowledge when it comes to use of a suction sheath in medium sized stones To add to the existing knowledge and bridge the gap of a randomised control trial comparing miniperc with and without a suction sheath for medium size stones, in this study, we compare Mini-PCNL with and without a suction sheath in renal calculi upto 3 cm in size.
|