Nephrolithotomy, Nephrostomy Tube (NT), Pain, Percutaneous Nephrolithotomy (PNL), Urolithiasis
Conditions
Keywords
Percutaneous nephrolithotomy (PNL), Nephrostomy tube (NT), Pain, Patient satisfaction
Brief summary
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
Interventions
PROCEDURElarge-bore nephrostomy tube (LBNT)
large-bore 22 french nephrostomy tube (LBNT)
PROCEDUREsmall-bore nephrostomy tube (SBNT)
small-bore 14 french nephrostomy tube (SBNT)
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hemoglobin reduction difference between groups | 8 months | measured in gram/liter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative patient satisfaction | 8 months | measured by The Freiburg Index of Patient Satisfaction (FIPS score) from 1 to 6 |
| postoperative pain score | 8 months | Assessed by Visual Analogue Scale (VAS) points from 0 to 10 |
| overall postoperative complication | 8 months | assesed by Clavien-Dindo system |
Countries
Egypt
Outcome results
None listed