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FloSeal Tubeless Exit Versus Cope Loop Nephrostomy Versus Fascial Stitch Following Percutaneous Nephrolithotripsy

University of California Irvine (UCI) logo

University of California Irvine (UCI)

Status

Completed

Conditions

Kidney Calculi

Treatments

Procedure: Fascial Stitch
Procedure: Floseal
Procedure: Cope Loop

Study type

Interventional

Funder types

Other

Identifiers

NCT00360477
2004-3515

Details and patient eligibility

About

The patient will be asked to participate in a research project designed to determine the best way to prevent bleeding and promote patient comfort after having kidney stones removed. Two standard methods for ending the surgery are being compared to a newer method. In one standard method, the patient will have a tube draining urine from the kidney after the procedure. This tube may also prevent bleeding from the kidney. In another standard method the patient will have a tube left internally that drains urine from the kidney to the bladder and a stitch will be used to close the incision and deeper tissues in the back. In the third potential option, a tube would be left internally to drain urine from the kidney to the patient's bladder and the surgical site would be filled with a clot promoting agent (FloSeal) which is a FDA approved agent specifically formulated to stop bleeding during surgical procedures.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The patient has kidney stones that require treatment (tx) with percutaneous stone removal
  • 18 years of age or over

Exclusion criteria

  • Patient mentally impaired, have a chronic pain syndrome or disorder, or any condition that might alter the sensation of pain
  • Patient taking coumadin
  • Pre-existing percutaneous nephrostomy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

59 participants in 3 patient groups

1
Active Comparator group
Description:
Floseal
Treatment:
Procedure: Floseal
2
Active Comparator group
Description:
Cope-Loop/Nephrostomy Tube
Treatment:
Procedure: Cope Loop
3
Active Comparator group
Description:
Fascial Stitch
Treatment:
Procedure: Fascial Stitch

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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