Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510790
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
Risk Factors for Bacterial Stent Colonization in Patients With a Double J Ureteral Stent
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Risk Factors for Bacterial Stent Colonization in Patients With a Double J Ureteral Stent a Prospective Study
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1921 and alligator forceps following the standard technique The equipment was sterilized with a 245 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
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 1921 and alligator forceps following the standard technique The equipment was sterilized with a 245 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None