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Regarding to the distribution of nephrostomy tube (NT) size usage by country. There was a clear distinction between countries that used solely the small bore (SB) NT (Chile and Australia) and those that used solely the large bore (LB) NT (Czech Republic and Japan). There is also a trend toward SB NT in North America (~75% in USA and Canada) and toward LB NT in South America (~80% in Argentina and Mexico). In Europe the trend is equal (~50% in Germany, France, Greece and UK). Based on previous data and in view of conflicting data about postoperative complication including extravasation, bleeding and hemoglobin change and pain between previous studies, we will conduct this randomised trial comparing SB and LB NT following PNL.
Our aim to evaluate the safety of small versus large bore NT reporting complications using the Clavien-Dindo system with categorisation of PNL-specific complications
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| large-bore nephrostomy tube (LBNT) | Active Comparator | large-bore 22 french nephrostomy tube (LBNT) |
|
| small-bore nephrostomy tube (SBNT) | Active Comparator | small-bore 14 french nephrostomy tube (SBNT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| large-bore nephrostomy tube (LBNT) | Procedure | large-bore 22 french nephrostomy tube (LBNT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of hemoglobin reduction difference between groups | measured in gram/liter | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain score | Assessed by Visual Analogue Scale (VAS) points from 0 to 10 | 8 months |
| postoperative patient satisfaction | measured by The Freiburg Index of Patient Satisfaction (FIPS score) from 1 to 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology and Nephrology Center | Al Mansurah | Aldakahlia | 35516 | Egypt |
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| D010146 | Pain |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| small-bore nephrostomy tube (SBNT) | Procedure | small-bore 14 french nephrostomy tube (SBNT) |
|
|
| 8 months |
| overall postoperative complication | assesed by Clavien-Dindo system | 8 months |
| D052801 | Male Urogenital Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |