| CTRI Number |
CTRI/2025/07/092092 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on the role of preventive antibiotics in reducing infections after kidney stone removal surgery |
|
Scientific Title of Study
|
Evaluation of prophylactic antibiotic usage in prevention of postoperative infection in patients undergoing 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 |
Vasavi kesana |
| Designation |
post graduate |
| Affiliation |
sri manakula vinayagar medical college and hospital |
| Address |
Room no 59 surgery opd department of surgery sri manakula vinayagar medical college and hospital, kalitheerthalkuppam, Madagadipet, puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7207563661 |
| Fax |
|
| Email |
vasavikesana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANTO |
| Designation |
PROFESSOR |
| Affiliation |
Sri Manakula vinayagar medical college and hospital |
| Address |
Room no 59 surgery opd department of surgery sri manakula vinayagar medical college and hospital, kalitheerthalkuppam, Madagadipet, puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9941470970 |
| Fax |
|
| Email |
drantomed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANTO |
| Designation |
PROFESSOR |
| Affiliation |
Sri Manakula vinayagar medical college and hospital |
| Address |
Room no 59 surgery opd department of surgery sri manakula vinayagar medical college and hospital, kalitheerthalkuppam, Madagadipet, puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9941470970 |
| Fax |
|
| Email |
drantomed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri manakula vinayagar medical college and hospital, kalitheerthalkuppam, Madagadipet, 605107 puducherry, India |
|
|
Primary Sponsor
|
| Name |
vVASAVI KESANA |
| Address |
Room no 59 surgery opd department of surgery sri manakula vinayagar medical college and hospital, kalitheerthalkuppam, Madagadipet, puducherry ,605107, India |
| 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 |
| Vasavi kesana |
Sri manakula vinayagar medical college and hospital |
Sri manakula vinayagar medical college and hospital, kalitheerthalkuppam, Madagadipet, puducherry
Pondicherry
PONDICHERRY |
07207563661
vasavikesana@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N20||Calculus of kidney and ureter, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Single preoperative dosage of Injection Amikacin |
To compare the effectiveness of single dose versus multidose prophylactic amikacin regimen in preventing postoperative infections among patients undergoing percutaneous nephrolithotomy |
| Intervention |
Three preoperative dosage of Injection amikacin |
To compare the effectiveness of single dose versus multidose prophylactic amikacin regimen in preventing postoperative infections among patients undergoing percutaneous nephrolithotomy
Total duration of 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age more than 18 years
2) Patients of male and female sex
3) Upper urinary tract stones of any size for which PCNL was recommended
4) Preoperative urine culture negative patients |
|
| ExclusionCriteria |
| Details |
) Antibiotic use within 2 weeks before randomization
2) contraindiaction to Injection amikacin
3)patients who are unable to tolerate surgery and anesthesia
4) patients who are having spinal deformity
5) pregnant or lactating female patients |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study is aimed to analyze the effectiveness of prophylactic antibiotics usage in prevention of postoperative infection rate in patients undergoing percutaneous nephrolithotomy |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
27/08/2025 |
| 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)
|
Open to Recruitment |
| 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
|
Postoperative infections are a common complication following Percutaneous Nephrolithotomy (PCNL), even in patients with negative preoperative urine cultures. While prophylactic antibiotics are routinely used to prevent such infections, there is ongoing debate over the optimal regimen, particularly between single-dose and multi-dose protocols. This randomized controlled trial aims to compare the effectiveness of single-dose versus multi-dose prophylactic Amikacin in preventing postoperative infections in PCNL patients with sterile urine cultures. By focusing on this specific patient subgroup and incorporating robust randomization and blinding methods, the study seeks to generate evidence-based recommendations that enhance patient outcomes while supporting antibiotic stewardship. The results may contribute to standardizing prophylactic antibiotic protocols for PCNL procedures. |