- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05911945
Failed Insertion of Ureteral Access Sheath During Flexible Ureterorenoscopy
Failed Insertion of Ureteral Access Sheath During Flexible Ureterorenoscopy: A Randomized Controlled Trial Comparing Second Session Flexible Ureterorenoscopy or Same Session Mini Percutaneous Nephrolithotomy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with renal calculi between 1 - 2 cm in diameter who were admitted to a tertiary health institution were evaluated prospectively. Patients who were unsuitable for shock wave lithotripsy (SWL) treatment or who did not benefit from SWL sessions were included in the study. Randomization was performed using a random number table with a central computerized system. Before the procedure, the patients were asked to complete the Turkish language validated form of the Short Form - 36 (SF - 36) questionnaire.
A total of 48 patients in whom ureteral access sheath insertion has failed during initial flexible ureterorenoscopy (f-URS) session were randomly divided into 2 groups. Group 1 underwent a JJ stent insertion and procedure terminated, while group 2 underwent mini percutaneous nephrolithotomy (mPNL) operation in the same session after prone positioning. Group 1 underwent f-URS 4-6 weeks later. One month after the operation, stone-free status was evaluated with computed tomography (CT) and detection of residual fragments of any size was defined as failure. The patients were asked to fill out the SF-36 questionnaire one month after the last surgery. Operative and postoperative data, SF-36 results, success, and complications were compared between the groups. The operation time included the time from initiation of cystoscopy to removal of amplatz for the mPNL group. For the F-URS group, it was calculated as the sum of the times between cystoscopy and fluoroscopy control of the JJ stent in both sessions.
Surgical technique All surgeries were performed by the same team of experienced surgeons in with high expertise in endourology. A guidewire was placed in the ureter in the lithotomy position. Ureterorenoscopy was performed with an 8 Fr ureterorenoscope for active dilatation. An 11 - 13 Fr or 9.5 / 11.5 Fr UAS was attempted to be placed under fluoroscopy by the surgeon of the procedure. In cases where the UAS could not inserted, a 26 cm, 4.8 Fr JJ stent was placed under fluoroscopy in the f-URS group, and the procedure was terminated. In the mPNL group, same session mPNL procedure was performed.
After initial JJ stent placement, patients in group 1 underwent a second f-URS session, 4 - 6 weeks later. After the JJ stent was removed, an 11 - 13 Fr UAS was placed in the ureter. Digital flexible ureterorenoscope was used as the flexible ureteroscope. Stone fragmentation was performed in dusting mode using a Ho:YAG laser with a 272 µ probe. After fragmentation, a 26 cm 4.8 Fr JJ stent was inserted into the ureter. The JJ stent was removed at 4 - 6 weeks postoperatively.
For patients in group 2, after placing a 5 Fr ureteral open-ended catheter, patients were positioned in prone position and access was performed to the appropriate calyx with an 18-gauge percutaneous access needle using the triangulation technique accompanied by fluoroscopy, in the first session. After the guidewire was introduced into the pelvicalyceal system, sequential dilatation was applied with Amplatz dilatators, and a 21 Fr metallic sheath was placed. Stones were fragmented with a yttrium-aluminum-garnet (Ho:YAG) Laser lithotripter. At the end of the procedure, a 14 Fr nephrostomy catheter was placed in according to the residual stone, hemorrhage, and perforation status. In other cases, the procedure was concluded as totally tubeless. Postoperative routine intravenous analgesia was not applied to all patients.
Study sample size analysis was computed using the G*Power program (effect size 0.5, alfa error 0.05, power 0.80). Statistical analysis was performed with 'Statistical Package for the Social Sciences' (SPSS) 25 program. The normality assessment of the distribution of the data was analyzed with the Shapiro-Wilk test and Q - Q plot. For continuous covariates, normality and homogeneity of each variable were evaluated and Student's or Welch's t-test was performed. Mann - Whitney U test was used for skewed data. Quantitative data were presented as mean ± standard deviation or median (IQR) values. Chi-square test or Fisher exact test (where the 20% of expected cell counts were less than 5) was used to compare qualitative data. The normality of the differences in SF - 36 data before and after the procedure was evaluated with the Skewness test and Q - Q plot. Paired-sample t - test was used to compare SF - 36 data before and after the procedure. The data were analyzed at 95% confidence level and the values with P < .05 were noted statistically significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sultangazi
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Istanbul, Sultangazi, Turkey, 34265
- Haseki Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with renal calculi between 1 - 2 cm in diameter
- Patients who were unsuitable for SWL treatment or who did not benefit from SWL sessions
Exclusion Criteria:
- Patients with kidney anomalies, (malrotated and horseshoe kidneys, kidneys with duplicated systems)
- Pregnant patients
- Patients younger than 18 years of age
- Patients who did not consent for inclusion in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Flexible Ureterorenoscopy
Underwent a JJ stent insertion and underwent f-URS 4-6 weeks later (Group 1).
|
A guidewire was placed in the ureter in the lithotomy position.
Ureterorenoscopy was performed with an 8 Fr ureterorenoscope for active dilatation.
An 11 - 13 Fr or 9.5 / 11.5 Fr UAS was attempted to be placed under fluoroscopy by the surgeon of the procedure.
In cases where the UAS could not inserted, a 26 cm, 4.8 Fr JJ stent was placed under fluoroscopy and the procedure was terminated.
Patients underwent a second f-URS session, 4 - 6 weeks later.
After the JJ stent was removed, an 11 - 13 Fr UAS was placed in the ureter.
Digital flexible ureterorenoscope was used as the flexible ureteroscope.
Stone fragmentation was performed in dusting mode using a Ho:YAG laser with a 272 µ probe.
After fragmentation, a 26 cm 4.8 Fr JJ stent was inserted into the ureter.
The JJ stent was removed at 4 - 6 weeks postoperatively.
|
Active Comparator: Mini Percutaneous Nephrolithotomy
Underwent mPNL operation in the same session after prone positioning (Group 2).
|
A guidewire was placed in the ureter in the lithotomy position.
Ureterorenoscopy was performed with an 8 Fr ureterorenoscope for active dilatation.
An 11 - 13 Fr or 9.5 / 11.5 Fr UAS was attempted to be placed under fluoroscopy by the surgeon of the procedure.
In cases where the UAS could not inserted, patients were positioned in prone position and access was performed to the appropriate calyx with an 18-gauge percutaneous access needle using the triangulation technique accompanied by fluoroscopy, in the same session.
After the guidewire was introduced into the pelvicalyceal system, sequential dilatation was applied with Amplatz dilatators, and a 21 Fr metallic sheath was placed.
Stones were fragmented with a yttrium-aluminum-garnet (Ho:YAG) Laser lithotripter.
At the end of the procedure, a 14 Fr nephrostomy catheter was placed in according to the residual stone, hemorrhage, and perforation status.
In other cases, the procedure was concluded as totally tubeless.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Short Form-36 parameters
Time Frame: Before surgery - 1 month after surgery
|
In order to evaluate the quality of life of the patients, pre- and postoperative SF-36 form values will be compared.
|
Before surgery - 1 month after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The success of the surgery
Time Frame: Before surgery - 1 month after surgery
|
Stone-free rates of the patients will be evaluated by computed tomography after surgery.
|
Before surgery - 1 month after surgery
|
Collaborators and Investigators
Investigators
- Study Director: Mehmet Akbulut, Assoc. Prof, Haseki Training and Research Hospital
Publications and helpful links
General Publications
- Perez-Fentes DA, Gude F, Blanco B, Freire CG. Percutaneous nephrolithotomy: short- and long-term effects on health-related quality of life. J Endourol. 2015 Jan;29(1):13-7. doi: 10.1089/end.2014.0081.
- Jiang K, Zhang P, Xu B, Luo G, Hu J, Zhu J, Sun F. Percutaneous Nephrolithotomy vs. Retrograde Intrarenal Surgery for Renal Stones Larger than 2cm in Patients with a Solitary Kidney: A Systematic Review and a Meta-Analysis. Urol J. 2020 Jul 28;17(5):442-448. doi: 10.22037/uj.v16i7.5609.
- Bensalah K, Tuncel A, Gupta A, Raman JD, Pearle MS, Lotan Y. Determinants of quality of life for patients with kidney stones. J Urol. 2008 Jun;179(6):2238-43; discussion 2243. doi: 10.1016/j.juro.2008.01.116. Epub 2008 Apr 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 256040791
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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