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Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube?

NCT04153474 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2019-11-06

No results posted yet for this study

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

Conditions

  • Urolithiasis
  • Nephrolithotomy
  • Percutaneous Nephrolithotomy (PNL)
  • Nephrostomy Tube (NT)
  • Pain

Interventions

PROCEDURE

large-bore nephrostomy tube (LBNT)

large-bore 22 french nephrostomy tube (LBNT)

PROCEDURE

small-bore nephrostomy tube (SBNT)

small-bore 14 french nephrostomy tube (SBNT)

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2020-02-01
Completion
2020-02-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153474 on ClinicalTrials.gov