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

Mansoura University

Status: Completed

Conditions: Tourniquet; Hypospadias, Coronal; Hypospadia, Repair; Hypospadias

Treatments: Procedure: Tourniquet; Procedure: Non-tourniquet

Study type: Interventional

Funder types: Other

Identifiers

NCT04239066

TOURNIQUE.HYPOSPADIAS

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: Male

Ages: 6 to 36 months old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Tourniquet

Experimental group

Description:

tubularized incided plate (TIP) urethroplasty plus tourniquet

Treatment:

Procedure: Tourniquet

Non-tourniquet

Experimental group

Description:

tubularized incided plate (TIP) urethroplasty plus non-tourniquet

Treatment:

Procedure: Non-tourniquet