- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04239066
Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes
February 22, 2021 updated by: Mansoura University
Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes. A Prospective Randomized Study
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Outside U.S./Canada
-
Mansoura, Outside U.S./Canada, Egypt, 35516
- Urology and nephrology center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 3 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Tourniquet
tubularized incided plate (TIP) urethroplasty plus tourniquet
|
tubularized incided plate (TIP) urethroplasty plus tourniquet
|
EXPERIMENTAL: Non-tourniquet
tubularized incided plate (TIP) urethroplasty plus non-tourniquet
|
tubularized incided plate (TIP) urethroplasty plus non-tourniquet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
assess Intraoperative blood loss
Time Frame: 12 months
|
by blood loss in milliliter in used gauze piece
|
12 months
|
bipolar diathermy use
Time Frame: 12 months
|
by number of bipolar diathermy usage
|
12 months
|
Surgeon satisfaction about haemostasis
Time Frame: 12 months
|
Surgeon satisfaction 4-tiered questionnaire (very satisfied, satisfied, unsatisfied and very unsatisfied).
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient-reported satisfaction
Time Frame: 24 months
|
by hypospadias objective scoring evaluation (HOSE) questionnaire
|
24 months
|
Long term complication rate
Time Frame: 60 months
|
number of surgery related complication after 5 years post operative
|
60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mohammed Dawaba, PhD, Mansoura University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2017
Primary Completion (ACTUAL)
December 1, 2018
Study Completion (ACTUAL)
December 1, 2019
Study Registration Dates
First Submitted
January 20, 2020
First Submitted That Met QC Criteria
January 20, 2020
First Posted (ACTUAL)
January 23, 2020
Study Record Updates
Last Update Posted (ACTUAL)
February 24, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TOURNIQUE.HYPOSPADIAS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypospadias
-
Albany Medical CollegeEnrolling by invitation
-
Sohag UniversityCompletedCosmotic Outcome of Distal Penile Hypospidias Repair Using Stitch by Stitch Glanuloplasty Versus TIPDistal Penile HypospadiasEgypt
-
Assiut UniversityNot yet recruiting
-
dr. Muhammad Abdelhafez Mahmoud, MDCompletedChordee | Hypospadias, Penoscrotal
-
Yonsei UniversityCompletedPediatric Patients Undergoing Hypospadias SurgeryKorea, Republic of
-
Tanta UniversityUnknownPediatric | Dexmedetomidine Infusion | Hypospadias Repair SurgeryEgypt
-
Isfahan University of Medical SciencesUnknown
-
Nemours Children's ClinicCompletedHypospadias and EpispadiasUnited States
-
Mansoura UniversityCompleted164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal BlockEgypt
Clinical Trials on Tourniquet
-
Hawler Medical UniversityCompletedUse of Tourniquet in Total Knee Arthroplasty
-
Hôpital NOVORecruiting
-
Hvidovre University HospitalWithdrawn
-
Marcus MiguraMercy HealthCompletedHemorrhage | Vascular InjuryUnited States
-
Per AspenbergCompleted
-
Ataturk UniversityErzurum Nenehatun Kadın Doğum HastanesiCompleted
-
Washington University School of MedicineZimmer BiometCompleted
-
University of Southern DenmarkBevica Fonden; The Danish Rheumatism AssociationUnknownKnee OsteoarthritisDenmark
-
Stanford UniversityCompletedHealthy SubjectUnited States