Standard Percutaneous Nephrolithotomy Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL

Phase 3

Completed

• Conditions: Nephrolithotomy
• Interventions: Procedure: Standard Percutaneous nephrolithotomy

• Registration Number: NCT01548196
• Lead Sponsor: Duke University

Brief Summary

The purpose of the study is to assess and compare the efficacy and morbidity standard percutaneous nephrolithotomy with tubeless PNL. A total of approximately 60 patients will be enrolled. Patients will be randomized to one of four groups: standard percutaneous nephrostomy, double-J ureteral stent, open-ended ureteral catheter and no nephrostomy or ureteral stent/catheter. Primary Outcome Measures will include length of procedure and estimated blood loss. Post-operative analgesic use (both parenteral and oral), pain scores, time to ambulation, time to oral intake, and pain scores will also be recorded. Time to nephrostomy tube removal, external ureteral and Foley catheter removal and patient discharge from the hospital will also be recorded. Incidence and type of post-operative complications will also be recorded.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Study First Submitted: 2011-10-18
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-08
• Last Update Submitted: 2015-03-12
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age >18 years old
• Planned single tract percutaneous nephrolithotomy
• General anesthesia for percutaneous nephrolithotomy

Read More

Exclusion Criteria

• Age<18 years old
• Known residual calculi at the end of the procedure
• Significant hemorrhage during procedure
• Bleeding disorder (This does not include patients taking anti-coagulants as these are stopped prior to surgery.)
• Prisoners
• Inability to give informed consent
• Pregnant females
• Solitary kidney
• Transplant kidney
• Pleural effusion during procedure requiring drainage
• Perforation of renal collecting system during procedure
• Incomplete stone clearance
• Chronic pain syndrome

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
double-J ureteral stent,	Standard Percutaneous nephrolithotomy	double-J ureteral stent,
standard percutaneous nephrostomy	Standard Percutaneous nephrolithotomy	Standard PCN
open-ended ureteral catheter	Standard Percutaneous nephrolithotomy	open-ended ureteral catheter

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	until hospital discharge, about 2-3 days	measuring days of hospital stay after procedure, and the effect that the location of the puncture has on the length of hospital stay
Change in CBC and Chemistry Panel	at time of hospital discharge, about 2-3 days	Loss of blood

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States