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Completed

NCT Number: NCT06510790

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Double J stent

Device

Double J ureteral catheter has been used to prevent upper urinary tract obstructions or strictures and to facilitate stone clearance after procedures such as percutaneous nephrolithotomy (PCNL), retrograde intrarenal surgery (RIRS), and ureteroscopic lithotripsy (URSL).

Other names: Ureteral stent

Primary outcomes

  1. Risk factors associated with bacterial colonization of DJS.

    Time frame: 4 weeks

    Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures.

Secondary outcomes

  1. The common microorganisms isolated from DJS in culture along with their drug susceptibility pattern.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tribhuvan University Teaching Hospital, Institute Of Medicine.

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2024
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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