Pain Clinical Trial
Official title:
Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube? Randomised Controlled Trial
Verified date | October 2019 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 220 |
Est. completion date | February 1, 2020 |
Est. primary completion date | February 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Staghorn calculi 2. Renal pelvis stones =>2 cm 3. Lower pole stones= >1.5 cm 4. upper ureteral calculi =>1.5 cm 5. SWL-resistant stones Exclusion Criteria: 1. Age <18 years or Pregnancy 2. Tubeless PNL 3. Need for 3 percutaneous tracts intraoperative 4. Morbid obesity (BMI >40) 5. Refuse to complete study requirements 6. Tumour in the presumptive access tract area or Potential malignant kidney tumour |
Country | Name | City | State |
---|---|---|---|
Egypt | Urology and Nephrology Center | Mansoura | Aldakahlia |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of hemoglobin reduction difference between groups | measured in gram/liter | 8 months | |
Secondary | postoperative pain score | Assessed by Visual Analogue Scale (VAS) points from 0 to 10 | 8 months | |
Secondary | postoperative patient satisfaction | measured by The Freiburg Index of Patient Satisfaction (FIPS score) from 1 to 6 | 8 months | |
Secondary | overall postoperative complication | assesed by Clavien-Dindo system | 8 months |
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