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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04239066

Enrollment

110

Registered

2020-01-23

Start date

2017-09-01

Completion date

2019-12-01

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypospadia, Repair, Hypospadias, Hypospadias, Coronal, Tourniquet

Keywords

Tourniquet, Hypospadias

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.

Interventions

PROCEDURETourniquet

tubularized incided plate (TIP) urethroplasty plus tourniquet

PROCEDURENon-tourniquet

tubularized incided plate (TIP) urethroplasty plus non-tourniquet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

6 Months to 36 Months

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026