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

Nephrolithotomy Clinical Trial

Official title:

A Prospective, Randomized Controlled Pilot Study Of Standard Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548196
• Other study ID #: Pro00004138
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2011
• Last updated: March 12, 2015
• Start date: February 2008
• Est. completion date: September 2011

Study information

• Verified date: March 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Institutional Review Board, USA:
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nephrolithotomy

Intervention

Procedure:
• Standard Percutaneous nephrolithotomy
Percutaneous nephrolithotomy

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Change in CBC and Chemistry Panel	Loss of blood	at time of hospital discharge, about 2-3 days	Yes