Clinical trial NCT06510790: Risk Factors for Bacterial Stent Colonization in Patients With a Double J Ureteral Stent
Official title: Risk Factors for Bacterial Stent Colonization in Patients With a Double J Ureteral Stent: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Colonization in Double J Ureteral Stent
Keywords: Colonization
Double J stent
Risk factors
Urinary tract infection
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients coming to TUTH OPD and ER for urological surgery were assessed for the placement of a DJS (polyurethane). Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures. All patients received prophylactic antibiotic therapy with levofloxacin for 2 to 3 days at the time of DJS insertion. The DJS was in situ until the duration allocated according to the procedure. The DJS was removed in 2 weeks postoperatively.

Brief summary: The goal of this prospective study is to identify the risk factors associated with bacterial colonization of DJS and report the common microorganisms isolated and drug susceptibility pattern.

Detailed description: This was a hospital-based prospective observational study performed at a tertiary academic center from March 2022 to August 2023.

All patients coming to TUTH OPD and ER for urological surgery were assessed for the placement of a DJS (polyurethane). Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures. All patients received prophylactic antibiotic therapy with levofloxacin for 2 to 3 days at the time of DJS insertion. The DJS was in situ until the duration allocated according to the procedure. The DJS was removed in 2 weeks postoperatively with aseptic precaution under local anesthesia (2% lignocaine jelly) with the help of a 30-degree Karl Storze scope with cystoscope sheath 19/21 and alligator forceps following the standard technique. The equipment was sterilized with a 2.45% Cidex solution for 12 minutes prior to all DJS removal. Then the patient was positioned in the lithotomy position, with proper cleaning of the external genitalia with povidone-iodine 10%, complete separation of the labia in the female, and proper cleaning of the prepuce and glans in the male. Then sterile xylocaine jelly 2% was instilled in the urethra, a cystoscope was inserted into the bladder, alligator forceps were inserted, and a DJS was removed. After removal of the DJS with sterile technique, the tips of both ends (renal end and bladder end) of the stent were cut with surgical blade number 10 and collected in a plastic screw-capped container, and sent for bacterial evaluation.

The report of the culture and sensitivity pattern were collected and treated according to the sensitivity pattern with appropriate antibiotics correlating with the symptoms. Colonization is defined as the growth of microorganisms in the tip culture of either end or both ends of DJS. All the demographic data with other study variables were recorded in proforma. Any amount of preoperative urine albumin from trace amounts and above (+,++, etc.) was considered in this study.

Eligibility criteria: Inclusion Criteria:

- Patients undergoing DJ stent placement

Exclusion Criteria:

* Positive urine culture before stenting
* Taking antibiotics during DJS removal
* Presence of yeasts in urine culture
* Declining informed consent

Primary outcomes:
measure: Risk factors associated with bacterial colonization of DJS.
timeFrame: 4 weeks
Secondary outcomes:
measure: The common microorganisms isolated from DJS in culture along with their drug susceptibility pattern.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Institute of Medicine
state: Bagmati
Study officials:
References: