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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Nephrolithotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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standard percutaneous nephrostomy

Standard PCN

Group Type OTHER

Standard Percutaneous nephrolithotomy

Intervention Type PROCEDURE

Percutaneous nephrolithotomy

double-J ureteral stent,

Group Type OTHER

Standard Percutaneous nephrolithotomy

Intervention Type PROCEDURE

Percutaneous nephrolithotomy

open-ended ureteral catheter

Group Type OTHER

Standard Percutaneous nephrolithotomy

Intervention Type PROCEDURE

Percutaneous nephrolithotomy

no nephrostomy or ureteral stent/catheter.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Standard Percutaneous nephrolithotomy

Percutaneous nephrolithotomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No