| CTRI Number |
CTRI/2024/09/074041 [Registered on: 19/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study outcome of supine percutaneous nephrolithotomy (PCNL) in renal stone patients |
|
Scientific Title of Study
|
Supine percutaneous nephrolithotomy (PCNL) in renal stone patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saurabh kumar |
| Designation |
M.Ch. urology resident |
| Affiliation |
Gandhi medical college |
| Address |
Department of urology
Gandhi medical college, Sultania road, Bhopal, Madhya pradesh
Department of urology
Gandhi medical college, Sultania road, Bhopal, Madhya pradesh
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7992369432 |
| Fax |
|
| Email |
saurabh.allen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Amit jain |
| Designation |
Associate professor |
| Affiliation |
Gandhi medical college |
| Address |
Department of urology
Gandhi medical college, Sultania road, Bhopal, Madhya pradesh
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8527025331 |
| Fax |
|
| Email |
amit9205@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Saurabh kumar |
| Designation |
M.Ch. Urology resident |
| Affiliation |
Gandhi medical college |
| Address |
Department of urology
Gandhi medical college, Sultania road, Bhopal, Madhya pradesh
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7992369432 |
| Fax |
|
| Email |
saurabh.allen@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi medical college, sultania road, Bhopal, Madhya pradesh, India, PIN 462001 |
|
|
Primary Sponsor
|
| Name |
Gandhi medical college |
| Address |
Department of urology
Gandhi medical college, sultania road, Bhopal, Madhya pradesh, India, PIN 462001 |
| Type of Sponsor |
Government 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 Saurabh kumar |
Gandhi medical college and hospital |
Department of urology, 4th floor, H-2 block
Bhopal
MADHYA PRADESH |
7992369432
saurabh.allen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Office of the chief executive officer and dean society, Gandhi medical college, sultania road, Bhopal |
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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients of renal stones requiring PCNL according to standard guidelines. |
|
| ExclusionCriteria |
| Details |
Patients with coagulopathy
Patients with abnormal anatomy of collecting system. Patient not fit for surgery and not willing to give consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To conclude the overall feasibility of supine PCNL. |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess complications associated with supine PCNL. To compare the outcome with the available data. |
1 year 6 months |
|
|
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)
|
30/09/2024 |
| 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 Applicable |
| 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
|
Percutaneous nephrolithotomy (PCNL) is considered the best treatment option for large and complex renal stones, which are difficult to manage by using other treatment modalities like ureteroscopy and shock wave lithotripsy (SWL) and retrograde intra renal surgery (RIRS). This minimally invasive surgical intervention has a high stone clearance rate with low morbidity. Traditionally PCNL is being done in prone position but it has evolved many a fold and was originally described in supine position by Valdivia et al. In this position the direction of the tract is posterior and thus preserves a low pressure in the renal pelvis, and thereby reduces the risk of fluid absorption and allows spontaneous clearance of fragments by gravity directed flow of fluid. Later on some new positions were described after doing some modification in the original Valdivia. Currently, PCNL is the treatment of choice for large renal stones, staghorn calculi, or in stones occurring in kidneys with abnormal anatomy. The morbidity of the PCNL in prone position been well documented. However, the supine approach’s safety and efficacy and potential advantages likely explain the increasing use of the supine position for stone management over the last ten years . Nevertheless, despite previously reported advantages, it has been pointed out that the supine position has its flaws, such as prolonged operative time in the case of larger stones. At present, current guidelines do not support one approach over the other. Therefore, controversy still exists regarding which position is safer and more effective for PCNL. In this study we aim to investigate the feasibility and outcome of the supine PCNL position by analyzing preoperative, intraoperative and post operative data and conclude outcomes of this position. |