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

NCT01548196 | Completed Phase 3 DMC

• 1 other identifier: Pro00004138
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrolithotomy

Keywords

nephrolithotomy

Outcome Measures

Primary Outcomes (2)

• Length of hospital stay

  measuring days of hospital stay after procedure, and the effect that the location of the puncture has on the length of hospital stay

  until hospital discharge, about 2-3 days

• Change in CBC and Chemistry Panel

  Loss of blood

  at time of hospital discharge, about 2-3 days

Study Arms (4)

standard percutaneous nephrostomy

OTHER

Standard PCN

Procedure: Standard Percutaneous nephrolithotomy

double-J ureteral stent,

OTHER

double-J ureteral stent,

Procedure: Standard Percutaneous nephrolithotomy

open-ended ureteral catheter

OTHER

open-ended ureteral catheter

Procedure: Standard Percutaneous nephrolithotomy

no nephrostomy or ureteral stent/catheter.

NO INTERVENTION

no nephrostomy or ureteral stent/catheter.

Interventions

Standard Percutaneous nephrolithotomy PROCEDURE

Percutaneous nephrolithotomy

double-J ureteral stent,; open-ended ureteral catheter; standard percutaneous nephrostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Glenn Preminger, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: March 8, 2012
• Study Start: February 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 17, 2015

Record last verified: 2012-03

Locations

US (1)