| CTRI Number |
CTRI/2026/01/100456 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of outcomes between Single-Dose Versus Three-Day Antibiotic dose in Lower Urinary Tract Endoscopic urological Procedures |
|
Scientific Title of Study
|
Comparison of Single-Dose Versus Three-Day Antibiotic Prophylaxis in Lower Urinary Tract Endourological Procedures: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srujan S Dharap |
| Designation |
Senior resident, academic |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Urology AIIMS Bhubaneswar
Department of urology, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
7350575383 |
| Fax |
|
| Email |
srujandharap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
kalandi Barik |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Urology AIIMS Bhubaneswar
Department of urology, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
7350575383 |
| Fax |
|
| Email |
urol_kalandi@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Srujan S Dharap |
| Designation |
Senior resident, academic |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Urology AIIMS Bhubaneswar
Department of urology, AIIMS Bhubaneswar
ORISSA
751019
India |
| Phone |
7350575383 |
| Fax |
|
| Email |
srujandharap@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
Department of Urology AIIMS Bhubaneswar, Odisha- India 751019 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Srujan S Dharap |
AIIMS Bhubaneswar |
AIIMS Bhubaneswar sijua-patrapada 751019
Khordha
ORISSA |
7350575383
srujandharap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for Faculty research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Cefuroxime |
single dose of pre operative cefuroxime 1.5 Gram will be given to the intervention group |
| Comparator Agent |
Injection Cefuroxime + Oral cefuroxime |
a single pre operative injection cefuroxime 1.5 Grams followed by post operative Injection cefuroxime 1.5 grams for post operative day 0 and oral cefuroxime 500 mg BD dose for later 2 days . ( Total 3 days of Cefuroxime - antibiotic ) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing elective TURP, TURBT, OIU, BNI, or CLT
Preoperative sterile urine culture (within 7 days prior to surgery)
Willing and able to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Evidence of preoperative UTI or positive urine culture
2. Immunocompromised status (e.g., HIV with CD4 <200, post-transplant, on immunosuppressants)
3. Chronic kidney disease (Stage IV or above)
4. Known allergy to cefuroxime or beta-lactam antibiotics
5. Patients requiring intraoperative or postoperative antibiotic escalation for other complications
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the rates of significant bacteriuria on POD 3 urine cultures in both groups |
To compare the rates of significant bacteriuria on POD 3 urine cultures in both groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Re-admission rate within 30 days for urinary sepsis or related complications |
within 30 days postop |
| incidence of asymptomatic bacteriuria |
within 30 days post op |
| adverse drug reaction |
after giving antibitic, till hospital stay |
| emergence of antibiotic resistant organisms |
in post operative cultures |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
19/01/2026 |
| 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
|
we plan To compare between 3 day postoperative dose of antibiotics vs single dose antibiotic in lower urinary tract surgeries. It is in practice to use 3 - 5 days of antibiotics for most of the urological procedures. Our goal is to find out the real world data and outcomes after using both the regimens. We will be including people undergoing Lower urinary tract surgeries with negative urine cultures within one week prior to surgery. we will use cefuroxime as antibiotic prophylaxis for all these patients as per institutional protocol. we will get done urine culture on day 3, and follow up the patient till 30 days of postoperative period to look for any symptomatic UTI. study duration would be around 18 months. we willl use computer based block randomization. |