Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes
Not Applicable
Completed
- Conditions
- Hypospadias, CoronalHypospadiasTourniquetHypospadia, Repair
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 110
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method assess Intraoperative blood loss 12 months by blood loss in milliliter in used gauze piece
Surgeon satisfaction about haemostasis 12 months Surgeon satisfaction 4-tiered questionnaire (very satisfied, satisfied, unsatisfied and very unsatisfied).
bipolar diathermy use 12 months by number of bipolar diathermy usage
- 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
Urology and nephrology center🇪🇬Mansoura, Outside U.S./Canada, Egypt