A two arm parallel study to evaluate whether single dose of prophylactic antibiotics before surgery is necessary in patients with negative urine culture undergoing endo-urological procedures like Ureteroscopy, Transurethral resection of bladder tumor, Transurethral resection of prostate.

Efficacy of Single-Dose Vs No Dose Pre surgical Prophylactic Antibiotics in Patients with Sterile Urine Undergoing Clean-Contaminated Endo-Urological Procedures: A Prospective Randomized Controlled Trial - NIL

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/06/088631

Enrollment

Registered

2025-06-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N399- Disorder of urinary system, unspecified

Interventions

Intervention1: Intravenous prophylactic antibiotic administration. : Single-dose of prophylactic antibiotic (Antibiotic to be used as per hospital policy) administered intravenously 30-60 minutes bef

Eligibility

Inclusion criteria

Inclusion criteria: Scheduled to undergo one of the following endo-urological procedures: Transurethral resection of bladder tumor (TURBT) Ureteroscopy with or without lithotripsy Percutaneous nephrolithotomy (PCNL) Transurethral resection of prostate (TURP) Direct Vision Internal Urethrotomy (DVIU) Documented sterile urine with negative urine culture (no growth) obtained within 7 days before surgery Able to provide written informed consent Willing to comply with follow-up schedule

Exclusion criteria

Exclusion criteria: Positive urine culture within 7 days before surgery Current antibiotic use or antibiotic use within 7 days before surgery Known hypersensitivity to the study antibiotic Active systemic infection Immunocompromised status Presence of indwelling urinary catheter or nephrostomy tube History of urinary tract infection within the past 30 days Pregnancy or breastfeeding Participation in another interventional clinical trial within the past 30 days Patients requiring additional procedures during the same surgery that may increase infection risk Severe renal or hepatic impairment Presence of pus in urinary tract Infective or Matrix stone

Design outcomes

Primary

Measure	Time frame
To determine whether single pre-surgical prophylactic antibiotic administration reduces the incidence of post- operative infectious complications in patients with sterile urine undergoing clean-contaminated endo- urological procedures.Timepoint: Prior to surgery Day 1 Post surgery Day 2 Post surgery Discharge day Day 30	—

Secondary

Measure	Time frame
To compare the rates of specific infectious complications (UTI, urosepsis, wound infection) between groups To assess the impact of no usage of prophylactic antibiotic use on hospital length of stay To evaluate the incidence of antibiotic-related adverse events To conduct an economic evaluation of prophylactic antibiotic use in this patient population To identify potential risk factors for post-operative infections despite sterile preoperative urine Timepoint: Prior to surgery Day 1 Post surgery Day 2 Post surgery Discharge day Day 30	—

Measure

Time frame

To compare the rates of specific infectious complications (UTI, urosepsis, wound infection) between groups To assess the impact of no usage of prophylactic antibiotic use on hospital length of stay To evaluate the incidence of antibiotic-related adverse events To conduct an economic evaluation of prophylactic antibiotic use in this patient population To identify potential risk factors for post-operative infections despite sterile preoperative urine Timepoint: Prior to surgery Day 1 Post surgery Day 2 Post surgery Discharge day Day 30

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Countries

India

Contacts

Public ContactDharmender Singh Lather

Indus International Hospital

rajan927@yahoo.com9781259923

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026