Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes

Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes. A Prospective Randomized Study

Although haemostasis aimed to maintain bloodless surgical field for better exposure for the surgeon, cosmetic impact, and decreased breakdown of repair, there is no trials regarding the impact of haemostasis techniques on surgeon satisfaction during surgery and patients reported outcomes.

Study Overview

• Status: Completed
• Conditions: Hypospadias; Tourniquet; Hypospadias, Coronal; Hypospadia, Repair
• Intervention / Treatment: Procedure: Tourniquet; Procedure: Non-tourniquet

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Outside U.S./Canada
    • Mansoura, Outside U.S./Canada, Egypt, 35516
      • Urology and nephrology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 3 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• distal penile hypospadias were eligible for tubularized incided plate (TIP) urethroplasty repair

Exclusion Criteria:

• coagulopathy
• sickle cell disease or sickle cell trait
• circumcised patient
• history of previous failed surgery
• severe chordee (>30 degree after degloving).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tourniquet; tubularized incided plate (TIP) urethroplasty plus tourniquet	Procedure: Tourniquet; tubularized incided plate (TIP) urethroplasty plus tourniquet
EXPERIMENTAL: Non-tourniquet; tubularized incided plate (TIP) urethroplasty plus non-tourniquet	Procedure: Non-tourniquet; tubularized incided plate (TIP) urethroplasty plus non-tourniquet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess Intraoperative blood loss	by blood loss in milliliter in used gauze piece	12 months
bipolar diathermy use	by number of bipolar diathermy usage	12 months
Surgeon satisfaction about haemostasis	Surgeon satisfaction 4-tiered questionnaire (very satisfied, satisfied, unsatisfied and very unsatisfied).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-reported satisfaction	by hypospadias objective scoring evaluation (HOSE) questionnaire	24 months
Long term complication rate	number of surgery related complication after 5 years post operative	60 months

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Mohammed Dawaba, PhD, Mansoura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2017
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 1, 2019

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 20, 2020
• First Posted (ACTUAL): January 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Tourniquet; Hypospadias
• Additional Relevant MeSH Terms: Pathologic Processes; Urogenital Abnormalities; Congenital Abnormalities; Penile Diseases; Ischemia; Hypospadias
• Other Study ID Numbers: TOURNIQUE.HYPOSPADIAS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No