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| Name | Class |
|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Xinchang County Hospital of Traditional Chinese Medicine | UNKNOWN |
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Nephrolithiasis is the most common chronic kidney condition and affecting approximately one in every 10-17 people in the world[1,2]. Flexible ureteroscopy (f-URS) has become one of the most common treatments for ureteral and renal stones with minimal complications. The development of ureteral access sheath (UAS) is a significant advance in flexible ureteroscopic management of urinary stones. The UAS has two major advantages: 1) facilitating multiple entries into the renal collecting system without causing recurrent trauma to the ureter and permit expeditious basketing of multiple stone fragments, 2) improving the irrigation with better fluid outflow, thereby reducing the renal pelvic pressure (RPP) and risk of infectious complications.
The tip bendable suction ureteral access sheath (S-UAS) is a novel UAS that has good flexibility and deformability at the tip, which can passively bend (bend >90°) with the bending of f-URS and can connect to a vacuum suction device. Preliminary study showed that S-UAS can follow f-URS to cross the UPJ and into the renal pelvis and calices. S-UAS close to the stone can achieve complete stone-free status in RIRS. However, further clinical studies and comparisons with available techniques are required. This prospective, single-blinded, single-center, randomized control trial will evaluate the stone free rates, operative time, postoperative complications following RIRS with S-UAS. To the best of our knowledge, this is the first study to compare the clinical benefits of RIRS with S-UAS and traditional UAS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tip bendable suction ureteral access sheath (S-UAS) group | Experimental | Patients will use S-UAS during flexible ureteroscopy. |
|
| Traditional ureteral access sheath group | No Intervention | Patients will use traditional UAS during flexible ureteroscopy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tip bendable suction ureteral access sheath | Procedure | Patient use tip bendable suction ureteral access sheath during flexible ureteroscopy to see if flexible ureteroscopy with S-UAS offers the better treatment outcomes in terms of clinical effectiveness and post-operative complications. |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate stone-free rate | No residual stone, or no stone fragments larger than 2 mm on KUB and ultrasound at postoperative day 1 are defined as stone free. | Postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Stone-free rate at 3 months | No residual stone, or no stone fragments larger than 2 mm on CT scan at postoperative 3 month are defined as stone free. | Postoperative 3 month |
| Duration of hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510230 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39070176 | Derived | Zhu W, Liu S, Cao J, Wang H, Liang H, Jiang K, Cui Y, Chai CA, Sahinler EB, Aquino A, Mazzon G, Zhong W, Zhao Z, Zhang L, Ding J, Wang Q, Wang Y, Chen KW, Liu Y, Choong S, Sarica K, Zeng G. Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study. EClinicalMedicine. 2024 Jul 5;74:102724. doi: 10.1016/j.eclinm.2024.102724. eCollection 2024 Aug. |
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| Prof. Dr. Ilhan Varank Education and Training Hospital | UNKNOWN |
| Jose R. Reyes Memorial Medical Center | OTHER_GOV |
| Guizhou Provincial People's Hospital | OTHER |
| University of Malaya | OTHER |
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|
| From date of operation until the date of discharge, assessed up to 2 weeks. |
| Further interventions received up to 3 months post randomization | Postoperative 3 month |
| Complications up to 3 months post randomization | Postoperative 3 month |
| Change of Quality of life Score (prior to surgery and at month 3 after randomization) | Postoperative 3 month |
| Operative time | The duration from the insertion of the endoscope into the urethra to the completion of stent placement. | From start of operation until the end of operation, assessed up to 2 weeks. |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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