| CTRI Number |
CTRI/2024/06/068895 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| 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
|
Safety of modified surgery in removal of kidney stones |
|
Scientific Title of Study
|
Safety and efficacy of mini percutaneous nephrolithotomy using suction sheath versus conventional sheath: A randomised 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 |
Rabindra Tamang |
| Designation |
MCh resident |
| Affiliation |
Maharajgunj Medical Campus, Institute of Medicine |
| Address |
Department of urology and kidney transplant surgery, Maharajgunj Medical Campus, Institute of Medicine, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal
44600
Other |
| Phone |
9842340090 |
| Fax |
|
| Email |
drrabindrayt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prem Raj Gyawali |
| Designation |
Professor |
| Affiliation |
Maharajgunj Medical Campus, Institute of Medicine |
| Address |
Department of urology and kidney transplant surgery, Maharajgunj Medical Campus, Institute of Medicine, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal
44600
Other |
| Phone |
9851033233 |
| Fax |
|
| Email |
premgyawali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rabindra Tamang |
| Designation |
MCh resident |
| Affiliation |
Maharajgunj Medical Campus, Institute of Medicine |
| Address |
Department of Urology and Kidney Transplant Surgery, Maharajgunj Medical Campus, Institute of Medicine, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal
44600
Other |
| Phone |
9842340090 |
| Fax |
|
| Email |
drrabindrayt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Urology and Kidney Transplant Surgery, Maharajgunj Medical Campus, Institute of Medicine, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal
Postal code: 44600 |
|
|
Primary Sponsor
|
| Name |
Rabindra Tamang |
| Address |
Maharajgunj Medical Campus, Institute of Medicine, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Nepal |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rabindra Tamang |
Tribhuvan University Teaching Hospital |
Department of Urology and Kidney Transplant Surgery, Institute of Medicine, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal
|
9842340090
drrabindrayt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Committe (IRC) of Institute of Medicine, Tribhuvan University |
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 |
Mini percutaneous nephrolithotomy using conventional sheath |
After dilatation of percutaneous tract, conventional Amplatz sheath of 16Fr will be placed in tract and stone will be fragmented using Pneumatic lithotripsy.
Total duration of intervention: operative time - approximately 30 minutes to 2.5 hours |
| Intervention |
Mini percutaneous nephrolithotomy using suction sheath |
After dilatation of percutaneous tract, mPCNL using suction sheath, 14/16Fr ClearPetra® nephrostomy sheath will be placed at percutaneous access port and connected to negative vacuum aspiration machine (200mmHg).
Total duration of intervention: operative time - approximately 30 minutes to 2.5 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing mPCNL in the Department of Urology and Kidney Transplant Surgery, TUTH |
|
| ExclusionCriteria |
| Details |
Age less than 18 years male and female patients
Patients with congenital anomalies of kidney like horse shoe kidney, duplex system or with diverticular disease
History of open intervention in ipsilateral kidney
Patients undergoing bilateral mPCNL or simultaneous retrograde intrarenal surgery (RIRS) or ureteroscopic lithotripsy
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Stone free rates |
6 weeks after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Operative time
2 Complications |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="0"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
21/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/06/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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
|
Mini percutaneous nephrolithotomy (mPCNL) is
standard treatment for nephrolithiasis with greater advantages of comparable
stone free rates and decreased complications as compared to standard PCNL. Application
of suctioning systems in mPCNL has been found to further enhance the stone free
rates and decrease the postoperative complications. In addition to this, as far as the literature search in Nepal is concerned, no
randomized control trial has been published yet. This
study aims to identify if mPCNL using suction sheath is safe and efficacious in
the treatment of nephrolithiasis.
This is a hospital based randomised
study. All the patients undergoing mPCNL at department of urology and kidney
transplant surgery will be eligible for study. Patients will be divided into mPCNL
using suction sheath and conventional sheath by simple random sampling and
comparison of various intraoperative and post-operative parameters will be done
to assess the safety and efficacy |