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

Not Applicable

Completed

• Conditions: Hypospadias, Coronal; Hypospadias; Tourniquet; Hypospadia, Repair
• Interventions: Procedure: Tourniquet; Procedure: Non-tourniquet

• Registration Number: NCT04239066
• Lead Sponsor: Mansoura University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-12-01
• Study Completion: 2019-12-01
• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-23
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 110

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tourniquet	Tourniquet	tubularized incided plate (TIP) urethroplasty plus tourniquet
Non-tourniquet	Non-tourniquet	tubularized incided plate (TIP) urethroplasty plus non-tourniquet

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Urology and nephrology center; 🇪🇬 Mansoura, Outside U.S./Canada, Egypt