Risk Factors for Bacterial Stent Colonization in Patients With a Double J Ureteral Stent

Completed

• Conditions: Bacterial Colonization in Double J Ureteral Stent
• Interventions: Device: Double J stent

• Registration Number: NCT06510790
• Lead Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.

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.

Study Timeline

• Study Start: 2022-03-01
• Primary Completion: 2023-06-15
• Study Completion: 2023-08-15
• Status Verified: 2024-07
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-18
• Last Update Submitted: 2024-07-18
• Study First Posted: 2024-07-19
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing DJ stent	Double J stent	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

Primary Outcome Measures

Name	Time	Method
Risk factors associated with bacterial colonization of DJS.	4 weeks	Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures.

Secondary Outcome Measures

Name	Time	Method
The common microorganisms isolated from DJS in culture along with their drug susceptibility pattern.	4 weeks	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. Any amount of preoperative urine albumin from trace amounts and above (+,++, etc.) was considered in this study.

Trial Locations

Locations (1)

Institute of Medicine; 🇳🇵 Kathmandu, Bagmati, Nepal