| 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
|
|
|
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
|
|
|
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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