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NCT04239066 Clinical Trial

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

Hypospadias Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04239066
Other study ID # TOURNIQUE.HYPOSPADIAS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2017
Est. completion date December 1, 2019

Study information
Verified date February 2021
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date December 1, 2019
Est. primary completion date December 1, 2018
Accepts healthy volunteers No
Gender Male
Age group 6 Months to 36 Months
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Tourniquet
tubularized incided plate (TIP) urethroplasty plus tourniquet
• Non-tourniquet
tubularized incided plate (TIP) urethroplasty plus non-tourniquet

Locations
Country Name City State
Egypt Urology and nephrology center Mansoura Outside U.S./Canada

Sponsors (1)
Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary assess Intraoperative blood loss by blood loss in milliliter in used gauze piece 12 months
Primary bipolar diathermy use by number of bipolar diathermy usage 12 months
Primary Surgeon satisfaction about haemostasis Surgeon satisfaction 4-tiered questionnaire (very satisfied, satisfied, unsatisfied and very unsatisfied). 12 months
Secondary Patient-reported satisfaction by hypospadias objective scoring evaluation (HOSE) questionnaire 24 months
Secondary Long term complication rate number of surgery related complication after 5 years post operative 60 months
See also
  Status Clinical Trial Phase
Completed NCT02752308 - Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair Phase 2/Phase 3
Not yet recruiting NCT03698721 - Urothelium Tissue Engineering Using Biopsies From Transurethral Resection of Prostate
Completed NCT03677453 - Interactive Perioperative Teaching Platform (IPTP) N/A
Terminated NCT04826484 - Opioid Reduction Initiative During Outpatient Pediatric Urologic Procedures Using Exparel Phase 3
Completed NCT02103712 - Long Term Outcome of Hypospadias Repair
Suspended NCT05093166 - Clinical Trial to Assess the Safety and Efficacy of Investigational Product in Patients Due to Hypospadias Treatment Failure Phase 1/Phase 2
Withdrawn NCT01762007 - The Change of the Detrusor Thickness After Hypospadias Repair - Comparison With the Normal Control Group
Not yet recruiting NCT05569863 - Identification of Hypospadias Parameters Using Digital Photography and Artificial Intelligence
Completed NCT02495090 - Hypospadias and Exome: Identification of New Genes for Familial Hypospadias N/A
Completed NCT04668183 - Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery
Completed NCT01370798 - Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications Phase 3
Recruiting NCT06417060 - Caudal Anesthesia Versus Local Anesthesia in Hypospadias N/A
Active, not recruiting NCT02861950 - Does Caudal Block Increase the Incidence of Urethrocutaneous Fistula Formation Following Hypospadias Repair in Infants? Phase 4
Not yet recruiting NCT06410482 - Analgesia in Pediatric Hypospadias Surgeries N/A
Terminated NCT02162810 - Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair N/A
Recruiting NCT05837000 - Dexmedetomidine, Ketamine and Magnesium Sulphate in Caudal Block for Hypospadias Repair Phase 4
Recruiting NCT05319782 - Long-term Assesment of Patients Operated for Hypospadias in Their Childhood : Urinary, Aesthetical, Sexual and Psycho-social Consequences N/A
Recruiting NCT05032222 - The Role of "Hypospadias Objective Scoring Evaluation" (HOSE) and Uroflowmetry in Evaluation of Successful Hypospadias Repair
Completed NCT05144659 - Evaluation of Double Faced Transverse Preputial Onlay Island Flap for Hypospadias Repair in Pediatrics N/A
Suspended NCT05708989 - Caudal vs. Pudendal Block in Peds GU Phase 4