| CTRI Number |
CTRI/2024/07/071294 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison for keeping DJ tent and ureteral catheter post PCNL surgery |
|
Scientific Title of Study
|
Comparison of double-J stenting versus ureteral catheters in percutaneous nephrolithotomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suhan Khamar |
| Designation |
2nd year Post Doctoral Trainee |
| Affiliation |
IPGMER and SSKMH |
| Address |
Department of Urology, IPGMER and SSKMH,
244, A.J.C. Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9429876581 |
| Fax |
|
| Email |
suhan.khamar72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kumar Rajiv Ranjan |
| Designation |
Assistant Professor |
| Affiliation |
IPGMER and SSKMH |
| Address |
Department of Urology, IPGMER and SSKMH,
244, A.J.C. Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9429876581 |
| Fax |
|
| Email |
dr.ranjanrajiv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suhan Khamar |
| Designation |
2nd year Post Doctoral Trainee |
| Affiliation |
IPGMER and SSKMH |
| Address |
Department of Urology, IPGMER and SSKMH,
244, A.J.C. Bose Road, Kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9429876581 |
| Fax |
|
| Email |
suhan.khamar72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Urology,
IPGMER and SSKMH,
244 AJC bose road
Kolkata-700020
State: West Bengal
Country: India |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Not Apllicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 Suhan Khamar |
SSKM Hospital |
Room number 7 and 10 ground floor and OT 4 7th floor,
Department of urology
Kolkata
WEST BENGAL |
9429876581
suhan.khamar72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Reasearch oversight 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 |
DJ stenting post PCNL |
After the completion of PCNL (Per Cutaneous Nephrolithotomy) surgery for renal calculus, patient is left with DJ stent in situ. The standard care in todays practice
The DJ is left in situ for 2-6 weeks |
| Intervention |
Ureteral catheter post PCNL surgery |
After the completion of PCNL (per Cutaneous Nephrolithotomy) surgery for renal calculus, patient is left with U-Cath (ureteral catheter) in situ, our study intervention
U-cath is removed on POD 2 |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ages above 12 years undergoing PCNL in department of Urology in IPGMER, KOLKATA.
Cumulative stone diameter ≤ 4 cm
No ureteral obstruction
Up to two access sites
Those consented to be part of study |
|
| ExclusionCriteria |
| Details |
Patient who did not gave consent for the study
Patients below age of 12 years
Cumulative stone diameter more than 4 cm
Presence of ureteral obstruction
More than 2 access sites |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine if ureteral Catheters have significantly reduced stent related complications when compared with double J stenting |
Day 1
Day 2
2 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine if ureteral catheters have comparable rates of complications for urinary extravasation and need for blood transfusion with double J stents |
Day 1
Day 2
2 Weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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 4 |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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="4"
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
|
This randomised control trial (open label) aims at comparing the placement of uretral catheters in patient post PCNL (intervention) with those in whom double J stents have been placed (the accepted standard). The study primarily aims to determine if the stent related symptoms are significantly less in ureteral catheter arm and secondarily to determine if there is any significant increase in other post operative complications (urinary extravasation, bleeding) |