| CTRI Number |
CTRI/2024/04/065508 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing efficacy of supine and prone PCNL in kidney stone patients |
|
Scientific Title of Study
|
A comparative study between Supine and Prone 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 |
Dr Devendra Singh Mehra |
| Designation |
Senior Resident |
| Affiliation |
RIMS,Imphal |
| Address |
Urology Department,RIMS Hospital,Imphal,Manipur
Imphal West MANIPUR 795001 India |
| Phone |
8433263215 |
| Fax |
|
| Email |
mehradevendra39@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Akoijam Kaku Singh |
| Designation |
Professor |
| Affiliation |
RIMS,Imphal |
| Address |
Urology Department,RIMS Hospital,Imphal,Manipur
Imphal West MANIPUR 795001 India |
| Phone |
8974057025 |
| Fax |
|
| Email |
drkakurims@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Khumukcham Somarendra |
| Designation |
Assistant Professor |
| Affiliation |
RIMS,Imphal |
| Address |
Urology Department,RIMS Hospital,Imphal,Manipur
Imphal West MANIPUR 795001 India |
| Phone |
9612165705 |
| Fax |
|
| Email |
drsomensingh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Devendra Singh Mehra |
| Address |
Urology Department,RIMS Hospital,Imphal,Manipur |
| Type of Sponsor |
Other [Self] |
|
|
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 Devendra Singh Mehra |
RIMS Hospital |
Urology department,First floor Room Number-3Lamphelpat,Imphal.Manipur Imphal West MANIPUR |
8433263215
mehradevendra39@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS |
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 |
| Comparator Agent |
prone percutaneous nephrolithotomy |
Patients presenting with renal stone disease in Urology OPD in RIMS Hospital,Imphal from September,2022 to August,2024(2 years) |
| Intervention |
Supine Percutaneous nephrolithotomy |
September, 2022 to August, 2024.(2 years) |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with lower calyceal and pelvic renal stone upto size 2cm. |
|
| ExclusionCriteria |
| Details |
1.Patients not willing to give consent to participate in the study.
2.Paediatric age group (<12year )
3.Bilateral stone disease.
4.Previous history of PCNL or pyelolithotomy.
5.Uncontrolled cougulopathy.
6.Abnormal renal anatomy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Operative time
2.Post op hemoglobin drop
3. Number of blood transfusions
4.Type of complications after procedure (if any)
|
zero day(intra-operative). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Need for Relook PCNL
2.Duration of Hospital Stay
3.Stone Free Rate at 4 weeks
|
At 1 week and 4 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 3 |
|
Date of First Enrollment (India)
|
23/04/2024 |
| 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="2" Months="0" 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
|
Urolithiasis is a global disease with a
prevalence rate of about 12% in Indian population and out of which 50% may end up with loss of
renal functions. PCNL (Percutaneous nephrolithotomy) stands as a gold standard surgical
treatment for renal calculus disease. It has gradually replaced conventional
open surgery for the removal of any size renal stone, specially large and
complex one.
Since its first description by Fernstrom and
Johansson in 1976, PCNL has traditionally been done with the patient prone,
combining a high success rate and acceptable low morbidity.
The prone position has certain advantages like wide field of
working area, easiness to puncture the calyx, shorter track length, ease of
tract dilation, ease to do multiple punctures etc.But is associated with many
problems like circulatory and ventilatory compromise because of compression on
the chest especially in the obese patient; cervical spine injuries, tracheal compression
and ocular injury during turning the patient; more fluid because of antigravity
drainage of fluid.
Concurrent RIRS (Retrograde intrarenal surgery) is difficult in
prone position. So there was a hunt in search of a new position which can
ameliorate the disadvantages of traditional prone position.First original
supine position was described by Valdivia et al. In this position the direction
of the tract is downward and thus preserves a low pressure in the renal pelvis,
and thereby reduces the risk of fluid absorption and allows spontaneous
clearance/washout of fragments by gravity directed flow of fluid.The main
limitation of this position is that the flank is not fully exposed, which makes
initial puncture more difficult.
In 2007 The Galdakao-modified supine Valdivia position was
described by Ibarluzea et al. for supine PCNL.
The
aim is to compare the surgical outcomes between prone and supine PCNL.
This study will be done in patients
who will be undergoing PCNL in urology department at RIMSH, Imphal, Manipur.
Study variables will include age, gender,BMI,post operative haemoglobin
drop,need for blood transfusion,mean operative time, number of patients
developing complications,mean hospital stay,need for relook PCNL and stone free
rate.
Patient will be evaluated with
history, physical examination, urine analysis, urine culture and sensitivity,
complete blood count, renal function tests, X-ray KUB, USG KUB, and Plain and
contrast enhanced computed tomography / IVP.It is a convenience non-probability sampling method where sample
is collected from a group of people easy to reach or contact.After that patient who will be undergoing
PCNL will be divided into two groups (Group A& Group B) which will be dicided by the cornerned operating surgeon.. Group A will
undergo prone PCNL and Group B will undergo supine PCNL after obtaining
anesthetic fitness for the procedure. P-value <0.05 will be taken as
statistically significant. |