Randomized Controlled Trial of Different Antibiotic Duration Prior to Prostate Enucleation Surgery

Phase 3Not Yet RecruitingNCT07209150

Ohio State University250 enrolled

Overview

To compare the risk of infectious complications (UTI, pyelonephritis, sepsis, hospital admission, ED visits) for patients with an indwelling urinary catheter (urethral or suprapubic) or CIC receiving 3 or 7 days of peri-operative antibiotic prophylaxis at time of Holmium Laser Enucleation of the Prostate

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

250

Conditions

BPH With Urinary Obstruction Antibiotic Prophylaxis

Interventions

antibiotic prophylaxisDRUG

we will compare varying durations of antibiotic prophylaxis prior to prostate enucleation surgery

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. Candidate for HoLEP surgery 2. Must be 18 years or older. 3. The patient must be able to understand and willing to provide informed consent as described in this study protocol. Exclusion Criteria: * 1\. Under the age of 18 2. Refuse to provide informed consent 3. Anticipated need for perineal urethrostomy 4. History of multi-drug resistant organism on urine culture that is not susceptible to any oral agents

Outcomes

Primary Outcomes

Infectious complications

UTI, pyelonephritis, sepsis, hospital admission, ED visits

Time frame: 0-90 days postoperatively

Secondary Outcomes

healthcare utilization

hospital admission or ED visits occurring post HoLEP

Time frame: 0-90days

Central Contacts

Matthew Lee, MD

CONTACT

614-293-8155 matthew.lee@osumc.edu

Data from ClinicalTrials.gov

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