| CTRI Number |
CTRI/2020/07/026933 [Registered on: 31/07/2020] Trial Registered Prospectively |
| Last Modified On: |
30/07/2020 |
| 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
|
OUTCOME OF RENAL STONE SURGERY WITH VERSUS WITHOUT TUBE INSERTION AFTER SURGERY |
|
Scientific Title of Study
|
ASSESSMENT OF EFFICACY, SAFETY AND POSTOPERATIVE OUTCOME OF STANDARD PERCUTANEOUS NEPHROLITHOTOMY VERSUS TUBELESS PERCUTANEOUS NEPHROLITHOTOMY IN CASES OF NEPHROLITHIASIS:A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuj Dumra |
| Designation |
DNB Urology Resident |
| Affiliation |
SSSIHMS Puttaparthi |
| Address |
Department of Urology
SSSIHMS
Puttaparthi
Ananthpur
Andhra pradesh
Puttaparthi Anantpur Andhra Pradesh
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
8177000009 |
| Fax |
|
| Email |
anujdumra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Chandrasekhar Rao |
| Designation |
Senior Consultant |
| Affiliation |
SSSIHMS Puttaparthi |
| Address |
Department of Urology
SSSIHMS
Puttaparthi
Ananthpur
Andhra pradesh
Puttaparthi Anantpur Andhra Pradesh
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
|
| Fax |
|
| Email |
chandra_uro62@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuj Dumra |
| Designation |
DNB Urology Resident |
| Affiliation |
SSSIHMS Puttaparthi |
| Address |
Department of Urology
SSSIHMS
Puttaparthi
Ananthpur
Andhra pradesh
Puttaparthi Anantpur Andhra Pradesh
Anantapur
ANDHRA PRADESH
515134
India |
| Phone |
8177000009 |
| Fax |
|
| Email |
anujdumra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sathya Sai Institute of Higher Medical sciences
Puttaparthi
Anantapur
Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
SSSIHMS Puttaparthi |
| Address |
Puttaparthi Ananthpur Andhra Pradesh (515134) |
| 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 |
| Anuj Dumra |
SSSIHMS |
Puttaparthi
Anantpur
Anantapur
ANDHRA PRADESH |
8177000009
anujdumra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SATYA SAI INSTITUTE OF HIGHER MEDICAL SCIENCES ETHICAL 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 (Percutaneous nephrolithotomy) |
Standard PCNL( with nephrostomy tube deployment post procedure) Versus Tubeless PCNL (no nephrostomy tube deployment)with 1:1 randomisation for study and control intervention
no fixed duration of procedures
no fixed frequency
equal numbers with minimum 50 in each group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Stone size more than 2 cm (any Guy’s stone score grade)
2. Single percutaneous tract
3. Complete stone clearance as assessed by intraoperative nephroscopy and fluoroscopy. |
|
| ExclusionCriteria |
| Details |
1.​Age less than 18 years and more than 50 years
2.​Residual calculi
3.​Significant bleeding at the end of procedure
4.​More than one percutaneous tract
5.​Preoperative deranged renal function tests
6.​History of previous surgery on ipsilateral urinary tract |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative pain and analgesia requirement |
Every 6 hours after surgery upto period of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare
Operative time
Fall in haemoglobin and blood transfusion requirement
Duration of urine leak
Duration of hospital stay
Complications between two techniques |
12 MONTHS |
|
|
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 1 |
|
Date of First Enrollment (India)
|
03/08/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Present study is a single institute, prospective study, with intention to compare and evaluate the effectiveness and safety of standard percutaneous nephrolithomy (PCNL) versus tubeless PCNL in the Department of Urology, Sri Sathya Sai Institute of Higher Medical Sciences – Prasanthigram, Anantapur, Andhra Pradesh. A minimum of 100 cases of renal stone disease that are willing to undergo PCNL will be included after taking written informed consent. Patients will be divided randomly into two groups involving minimum of 50 patients in each group. Group A patients will undergo Tubeless PCNL procedure and Group B patients will undergo Standard PCNL. The routine evaluation of patients enrolled in the study will be done as per the structured proforma. The efficacy and safety of the operative procedure will be analyzed based on postoperative pain score, analgesia requirement, fall in haemoglobin, blood transfusion requirement, duration of hematuria, duration of urine leak, duration of hospital stay and any other postoperative complications.The purpose of this study is to objectively compare the standard and tubeless PCNL depending on different variables and at the end of the study to provide guidance regarding preference of choice among the two methods in cases of nephrolithiasis. |