| CTRI Number |
CTRI/2024/01/061137 [Registered on: 05/01/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Create a objective Pentafecta scoring to quantify the results of miniPCNL surgeries and to create a benchmark. |
|
Scientific Title of Study
|
Defining Pentafecta outcomes of miniPCNL (less than or equal to 22Fr) for renal stone (less than or equal to 3cms). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddhant Kumar |
| Designation |
Senior Resident |
| Affiliation |
KMC, Manipal |
| Address |
Room no 14, Urology OPD, Department of Urology, Kasturba
hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7042132361 |
| Fax |
|
| Email |
kumar.siddhant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Chawla |
| Designation |
Professor and HOU, Department of Urology |
| Affiliation |
KMC, Manipal |
| Address |
Room no 14, Urology OPD, Department of Urology, Kasturba
hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9008002440 |
| Fax |
|
| Email |
urologyarun@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Chawla |
| Designation |
Professor and HOU, Department of Urology |
| Affiliation |
KMC, Manipal |
| Address |
Room no 14, Urology OPD, Department of Urology, Kasturba
hospital, Manipal
KARNATAKA
576104
India |
| Phone |
9008002440 |
| Fax |
|
| Email |
urologyarun@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
KMC, Manipal |
| Address |
Kasturba Medical College, Manipal, MAHE, 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 Siddhant Kumar |
Kasturba Hospital, Manipal |
In-patient Ward,
Department of Urology and Renal Transplant,
Kasturba Hospital,
Manipal, Karnataka 576104
Udupi
KARNATAKA |
7042132361
kumar.siddhant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC AND KH IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing mini PCNL with stone size 1-3cms
Age more than 18 years
Willing to consent for study |
|
| ExclusionCriteria |
| Details |
Patients who opted for RIRS, ESWL.
Stone size > 3cms
Age less than 18 years
Contraindications for PCNL like pregnancy, bleeding diathesis, untreated urinary tract infection, tumor in the presumptive access tract area, and potential malignant kidney tumors |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary : To standardize miniPCNL results on a quantifiable scale using a “Pentafecta of miniPCNLâ€
(i) Clinically Insignificant Stone Residue : <4mm seen on NCCT KUB done at 4 weeks.
(ii) Modified Clavein dindo classification for complications (with significant being > or equal to Grade II)
(iii) Tubeless/Totally Tubeless
(iv) eGFR values : Pre-op, on Post-op day 1 and Post-op value at 4 weeks.
(v) Ancillary procedure – within 1 month |
4 weeks or one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing various methods of lithotripsy in achieving Pentafecta |
4 weeks or one month |
|
|
Target Sample Size
|
Total Sample Size="281"
Sample Size from India="281"
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)
|
12/01/2024 |
| 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="6"
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
|
Patients will be operated under general anaesthesia. Patients will be first placed in the lithotomy position for the placement of ureteric catheter and per-urethral catheter after which they will be turned prone. Calyx will be punctured by initial puncture needle under fluoroscopic guidance. • A flexible 0.035†terumo guidewire was then inserted into the renal collecting system, preferably in the ureter or else in the upper pole calyx/second favorable calyx. The access needle was removed, and the skin and fascia were incised. Tract dilatation will be done up to maximum of 22 French. Stones will be fragmented by holmium/thulium laser. Post lithotripsy, patients would be divided into three groups: DJ stented, Totally tubeless PCNL or with overnight Ureteric catheter. Patients will be considered for Totally tubeless or with overnight Ureteric Catheter only in cases with no PCS injury, mild hematuria and no residual fragments on fluoroscopy. Patients with larger stone burden/ PCS injury will be chosen for tubeless PCNL (Double J stent). Amplatz sheath will be removed after observing any hematuria or tract bleeding. Intra-operative data will be recorded based on: Number of tracts Puncture Site Tract Dilatation Energy Used External drainage Post-op stone free status will be evaluated as per the standard of care, by follow-up NCCT KUB for residual stones at 4 weeks. “Zero Stone Residue†(<1mm) Clinically insignificant residual fragments(<4mm) [CIRF] Clinically significant residual fragments(>4mm) [CSRF] Complications will be classified according to Modified Clavien Dindo Classification. eGFR will be calculated using the Cockroft-Gault formula using POD-1 and 1 month post op S.Creatinine levels (these blood tests are part of the routine work up of the patient and no extra tests are being done for the sake of the study).
Outcomes would be measured and used to compare. |