Bacterial Colonization in Double J Ureteral StentNCT06510790
Risk Factors for Bacterial Stent Colonization in Patients With a Double J Ureteral Stent
An observational study of Bacterial Colonization in Double J Ureteral Stent, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacterial Colonization in Double J Ureteral Stent
- What is being tested?
- Double J stent
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteNepal
- Study dates
- 1 Mar 2022to 15 Aug 2023
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients undergoing DJ stent placement
Who cannot join
- Positive urine culture before stenting
- Taking antibiotics during DJS removal
- Presence of yeasts in urine culture
- Declining informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Bacterial Stent Colonization in Patients With a Double J Ureteral Stent: a Prospective Study
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.
Read the 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.
- Being tested
- Double J stent
- Keywords
- Colonization, Double J stent, Risk factors, Urinary tract infection
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double J stentDevice
Also called Ureteral stent
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing DJ 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 Receives: Device: Double J stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk factors associated with bacterial colonization of DJS.
Patients fulfilling inclusion criteria were admitted and underwent DJS placement after their respective procedures.
Measured: 4 weeks
Secondary outcomes (1)
The common microorganisms isolated from DJS in culture along with their drug susceptibility pattern.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Mar 2022
- Primary completion15 Jun 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Colonization in Double J Ureteral StentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ishwor Thapaliya, Tribhuvan University Teaching Hospital, Institute Of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510790
- Sponsor's protocol ID
- 510 (6-11)
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Individual Participant Data (IPD) to be shared for registration on ClinicalTrials.gov will include demographic details (age, sex), preoperative characteristics (hemoglobin levels, albuminuria), procedural information (stent type, duration), microbiological findings (bacterial species, drug sensitivity), and clinical outcomes (complications, mortality). These data will facilitate analysis of risk factors for bacterial colonization in patients with double J ureteral stents and guide future research and clinical practice.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Bacterial Stent Colonization in Patients With a Double J Ureteral Stent: a Prospective Study
- ClinicalTrials.gov ID
- NCT06510790
- Acronym / sponsor ID
- 510 (6-11)
- Keywords
- Colonization, Double J stent, Risk factors, Urinary tract infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tribhuvan University Teaching Hospital, Institute Of Medicine.University, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing DJ stent | – | Device: Double J stentAll 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients undergoing DJ stent placement
Key exclusion criteria (4 listed)
- Positive urine culture before stenting
- Taking antibiotics during DJS removal
- Presence of yeasts in urine culture
- Declining informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double J stentAlso: Ureteral stentDouble 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). | Device | Patients undergoing DJ stent |
Primary outcome
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.
1 secondary outcome
The common microorganisms isolated from DJS in culture along with their drug susceptibility pattern.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Individual participant dataSharing planned: Yes. The Individual Participant Data (IPD) to be shared for registration on ClinicalTrials.gov will include demographic details (age, sex), preoperative characteristics (hemoglobin levels, albuminuria), procedural information (stent type, duration), microbiological findings (bacterial species, drug sensitivity), and clinical outcomes (complications, mortality). These data will facilitate analysis of risk factors for bacterial colonization in patients with double J ureteral stents and guide future research and clinical practice.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Colonization in Double J Ureteral Stent, run by Tribhuvan University Teaching Hospital, Institute Of Medicine. at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors associated with bacterial colonization of DJS. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.