Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Hypospadias
  • Urethrocutaneous Fistula
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 42 years
Gender
Only males

Description

Small retrospective series are in conflict about whether there is an association between caudal block and urethrocutaneous fistulas after hypospadias repair. The most common alternative to caudal blockade is a penile nerve block. The investigators will test the following hypothesis: There is no diff...

Small retrospective series are in conflict about whether there is an association between caudal block and urethrocutaneous fistulas after hypospadias repair. The most common alternative to caudal blockade is a penile nerve block. The investigators will test the following hypothesis: There is no difference in the incidence of urethrocutaneous fistula formation following single stage hypospadias repair with caudal anesthesia compared with penile nerve block. The investigators will use a prospective randomized controlled design where subjects will receive either a caudal block or a penile nerve block to provide postoperative analgesia. Meatal anatomy will be graded by the urologist in the anesthetized child according to the HOPE (Hypospadias Objective Penile Evaluation) score, a validated scoring system. Both the total score and the individual component scores will be recorded. The operating urologist will determine the presence or absence of a fistula at the postoperative visit about 12 weeks after surgery, with subsequent follow up at 6 months and again at 12 months.

Tracking Information

NCT #
NCT02861950
Collaborators
  • Stanford University
  • Dartmouth-Hitchcock Medical Center
  • Northwestern University
  • Boston Children's Hospital
  • Children's Medical Center Dallas
  • University of Mississippi Medical Center
  • University of New Mexico
  • University of Wisconsin, Madison
  • University of Iowa
  • The University of Texas Health Science Center, Houston
  • Oregon Health and Science University
  • Joe DiMaggio Children's Hospital
  • University of Michigan
  • Children's National Health System
Investigators
Principal Investigator: David M Polaner, MD University of Colorado, Denver