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This study was withdrawn prior to enrollment initiation due to the publication of similar studies with the same research objectives.
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Urolithiasis is a common disease in urology. With the continuous progress of science and technology, the treatment of kidney lithiasis has undergone revolutionary changes, and the previously commonly used open surgical lithotomy method has been gradually eliminated, and replaced with less traumatic treatment methods. Percutaneous nephroscopy can theoretically treat the vast majority of kidney stones, especially in the treatment of kidney stones > 2 cm, it is widely used. With the development of ureteroscopy technology, the adaptation of ureteroscopy for the treatment of kidney stones has been expanding, and people have gradually paid attention to it with less damage and higher safety. This study aims to evaluate whether the efficacy and safety of soft ureteral lithotomy in the treatment of 2-4cm kidney stones is equal to that of percutaneous nephrolithotomy through prospective randomized controlled clinical trials, so as to provide more choices for physicians and patients, and provide theoretical basis for the standardization of clinical practice and the rationality of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flexible ureteroscopic lithotripsy | Experimental |
| |
| percutaneous nephrolithotomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flexible ureteroscopic lithotripsy | Procedure | This group of patients underwent flexible ureteroscopic lithotripsy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stone free-rate (SFR) | Stone-free status is defined as the absence of any residual stone fragments or the presence of clinically meaningless residual stone fragments in the kidney, defined as ≤4mm, asymptomatic, non-obstructive, and non-infectious stone particles. | All patients underwent a 2mm plain CT scan 1 month after surgery to assess final SFR. |
| Measure | Description | Time Frame |
|---|---|---|
| Time of operation | Time of operation:From transurethral surgery to indwelling fistula or catheter. | From transurethral surgery to indwelling fistula or catheter, assessed up to 6 hours. |
| Length of stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yanbowang | Ch’ang-ch’un | Jilin | 130000 | China |
There is a plan to make IPD and related data dictionaries available.
starting 6 months after publication
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| percutaneous nephrolithotomy | Procedure | This group of patients underwent percutaneous nephrolithotomy. |
|
Length of stay: from leaving the operating room to discharge
| From leaving the operating room to discharge,assessed up to 1 month. |
| Postoperative complication | Postoperative complication:Any surgery-related adverse events that occurred during or less than one month after surgery | Any surgery-related adverse events that occurred during or less than one month after surgery. |
| Hospitalization costs | Hospitalization costs: Total costs during hospitalization | From admission to discharge,assessed up to 1 month. |
| 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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| ID | Term |
|---|---|
| D000074642 | Nephrolithotomy, Percutaneous |
| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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