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CTRI Number  CTRI/2024/03/063953 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 08/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Outcome of guideline directed pre-operative prophylactic single dose/day vs extended prophylactic antibotics for urological surgeries 
Scientific Title of Study   Outcome of guideline directed pre-operative prophylactic single dose/day vs extended prophylactic antibotics for urological surgeries A Randomized controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajath S Shetty 
Designation  Senior Resident  
Affiliation  AIIMS New Delhi 
Address  c4 ward department of urology, AIIMS New Delhi

North
DELHI
110029
India 
Phone  8867626477  
Fax    
Email  rajath.shetty10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rishi Nayyar 
Designation  Additional professor 
Affiliation  AIIMS New Delhi 
Address  c4 ward department of urology, AIIMS New Delhi

North
DELHI
110029
India 
Phone  8867626477  
Fax    
Email  nayyarrishi2020@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajath S Shetty 
Designation  Senior Resident  
Affiliation  AIIMS New Delhi 
Address  c4 ward department of urology, AIIMS New Delhi

North
DELHI
110029
India 
Phone  8867626477  
Fax    
Email  rajath.shetty10@gmail.com  
 
Source of Monetary or Material Support  
AIIMS New Delhi AIIMS new dehli, Ansari nagar new delhi 110029 
 
Primary Sponsor  
Name  Rajath S Shetty 
Address  senior resident, department of urology AIIMS New Delhi 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajath S Shetty   AIIMS New delhi  C4 ward Department of urology AIIMS, Ansari nagar
New Delhi
DELHI 
8867626477

rajath.shetty10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Ethics Commitee gor post graduate research AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Antibiotics   Extended spectrum of antibiotics is given post surgery  
Intervention  Antibiotics   single dose of antibiotics preoperatively or continued for one day post surgery 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients undergoing elective urological surgeries under general anesthesia. Age ≥5 to ≤ 75 years.
 
 
ExclusionCriteria 
Details  Patient refusing to consent to study or is unwilling to participate or with multiple comorbidities 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
30-day rate of clinical UTI after urological procedures with single dose/day preoperative antibiotic against extended antibiotic therapy  At baseline, at 1 week after surgey and 30 days post surgey 
 
Secondary Outcome  
Outcome  TimePoints 
1-week rate of clinical UTI, 1-week and 30-day bacteriuria rates, 1-week and 30-day asymptomatic bacteriuria rates, 1-week and 30-day septicemia rates
 
1 week, 30 days 
 
Target Sample Size   Total Sample Size="337"
Sample Size from India="337" 
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 4 
Date of First Enrollment (India)   18/03/2024 
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 Yet Recruiting 
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  

Post-procedural genito-urinary tract infection (UTI) is a frequent occurrence in the clinical setting with associated morbidity, cost of treatment and possible long-term sequelae. Most urological procedures are either Class 1 or 2 procedures with recommended single-shot antibiotic prophylaxis for most. Urological surgeries differ from other surgeries in that (a) Flora that causes surgical site infections is markedly different from cutaneous flora, with more pre-disposition of gram-negative enterobacteriaceae (b) Use of continuous high pressure irrigation in endo-urological surgeries to distend the endoscopic surgical field, resulting in pyelovenous and pyelolymphatic backflow predisposing to development of bacteremia and endotoxiemia, and (c) Frequent use of foreign bodies like stents, catheter or nephrostomy before and after the surgery. As a result, the general recommendations for surgical site infections are not directly applicable to endourological surgery [1].  Even though, most guidelines recommend only a single dose/day of antibiotic prophylaxis for most endourological cases, the use of antibiotics in the peri-operative period is extremely diverse with wide differences between different regions, different hospitals, and even different consultants in same surgical unit. In real-world practice, peri-operative antibiotics use is heavily driven by apprehension of gram-negative bacteremia, endotoxemia and sepsis. Such use stands against the larger community goal of minimizing use of antibiotics wherever feasible. Therefore, there is huge need to reduce this clinical gap between guidelines and actual clinical practice(1). This study seeks to find out if there is any difference between the guideline directed preoperative prophylactic single dose/day vs extended prophylactic antibiotic course for urological surgeries in a prospective randomized manner.

 
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