Failed Insertion of Ureteral Access Sheath During Flexible Ureterorenoscopy
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ClinicalTrials.gov Identifier: NCT05911945 |
Recruitment Status :
Completed
First Posted : June 22, 2023
Last Update Posted : June 23, 2023
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Condition or disease | Intervention/treatment | Phase |
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Kidney Calculi | Procedure: Flexible Ureterorenoscopy Procedure: Mini Percutaneous Nephrolithotomy | Not Applicable |
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Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Failed Insertion of Ureteral Access Sheath During Flexible Ureterorenoscopy: A Randomized Controlled Trial Comparing Second Session Flexible Ureterorenoscopy or Same Session Mini Percutaneous Nephrolithotomy |
Actual Study Start Date : | September 10, 2020 |
Actual Primary Completion Date : | September 10, 2021 |
Actual Study Completion Date : | December 1, 2021 |
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Arm | Intervention/treatment |
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Active Comparator: Flexible Ureterorenoscopy
Underwent a JJ stent insertion and underwent f-URS 4-6 weeks later (Group 1).
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Procedure: Flexible Ureterorenoscopy
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).
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Procedure: Mini Percutaneous Nephrolithotomy
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. |
- 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.
- 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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05911945
Turkey | |
Haseki Training and Research Hospital | |
Istanbul, Sultangazi, Turkey, 34265 |
Study Director: | Mehmet Akbulut, Assoc. Prof | Haseki Training and Research Hospital |
Responsible Party: | Ufuk Çağlar, M.D, Haseki Training and Research Hospital |
ClinicalTrials.gov Identifier: | NCT05911945 |
Other Study ID Numbers: |
256040791 |
First Posted: | June 22, 2023 Key Record Dates |
Last Update Posted: | June 23, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
kidney calculi percutaneous nephrolithotomy retrograde intrarenal surgery quality of life |
Kidney Calculi Nephrolithiasis Calculi Pathological Conditions, Anatomical Kidney Diseases Urologic Diseases |
Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Urolithiasis Urinary Calculi Male Urogenital Diseases |