Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube?
1 other identifier
interventional
220
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedNovember 6, 2019
October 1, 2019
9 months
November 4, 2019
November 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of hemoglobin reduction difference between groups
measured in gram/liter
8 months
Secondary Outcomes (3)
postoperative pain score
8 months
postoperative patient satisfaction
8 months
overall postoperative complication
8 months
Study Arms (2)
large-bore nephrostomy tube (LBNT)
ACTIVE COMPARATORlarge-bore 22 french nephrostomy tube (LBNT)
small-bore nephrostomy tube (SBNT)
ACTIVE COMPARATORsmall-bore 14 french nephrostomy tube (SBNT)
Interventions
large-bore 22 french nephrostomy tube (LBNT)
small-bore 14 french nephrostomy tube (SBNT)
Eligibility Criteria
You may qualify if:
- Staghorn calculi
- Renal pelvis stones =\>2 cm
- Lower pole stones= \>1.5 cm
- upper ureteral calculi =\>1.5 cm
- SWL-resistant stones
You may not qualify if:
- Age \<18 years or Pregnancy
- Tubeless PNL
- Need for 3 percutaneous tracts intraoperative
- Morbid obesity (BMI \>40)
- Refuse to complete study requirements
- Tumour in the presumptive access tract area or Potential malignant kidney tumour
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Urology and Nephrology Center
Al Mansurah, Aldakahlia, 35516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 4, 2019
First Posted
November 6, 2019
Study Start
May 1, 2019
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
November 6, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share