HypospadiasNCT04239066
Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes
A study testing Tourniquet and Non-tourniquet in people with Hypospadias and Hypospadias, Coronal, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 6 to 36 months, men only
- Conditions the study is for
- Hypospadias, Hypospadias, Coronal, Hypospadia, Repair
- What is being tested?
- Tourniquet and Non-tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2017to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- distal penile hypospadias were eligible for tubularized incided plate (TIP) urethroplasty repair
Who cannot join
- coagulopathy
- sickle cell disease or sickle cell trait
- circumcised patient
- history of previous failed surgery
- severe chordee (>30 degree after degloving).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Urology and nephrology center
Al Mansurah, Outside U.S./Canada, 35516
About this study
Official title: 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.
- Conditions
- Hypospadias, Hypospadias, Coronal, Hypospadia, Repair, Tourniquet
- Being tested
- Tourniquet, Non-tourniquet
- Keywords
- Tourniquet, Hypospadias
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TourniquetProcedure or surgery
tubularized incided plate (TIP) urethroplasty plus tourniquet
Non-tourniquetProcedure or surgery
tubularized incided plate (TIP) urethroplasty plus non-tourniquet
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet | Experimental | tubularized incided plate (TIP) urethroplasty plus tourniquet Receives: Procedure: Tourniquet |
| Non-tourniquet | Experimental | tubularized incided plate (TIP) urethroplasty plus non-tourniquet Receives: Procedure: Non-tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess Intraoperative blood loss
by blood loss in milliliter in used gauze piece
Measured: 12 months
bipolar diathermy use
by number of bipolar diathermy usage
Measured: 12 months
Surgeon satisfaction about haemostasis
Surgeon satisfaction 4-tiered questionnaire (very satisfied, satisfied, unsatisfied and very unsatisfied).
Measured: 12 months
Secondary outcomes (2)
Patient-reported satisfaction
by hypospadias objective scoring evaluation (HOSE) questionnaire
Measured: 24 months
Long term complication rate
number of surgery related complication after 5 years post operative
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Sep 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammed Dawaba, PhD, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239066
- Sponsor's protocol ID
- TOURNIQUE.HYPOSPADIAS
- Status last verified
- Feb 2021
- First submitted
- 20 Jan 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes. A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04239066
- Acronym / sponsor ID
- TOURNIQUE.HYPOSPADIAS
- Conditions
- Hypospadias, Hypospadias, Coronal, Hypospadia, Repair, Tourniquet
- Keywords
- Tourniquet, Hypospadias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tourniquet | Experimental | Procedure: Tourniquettubularized incided plate (TIP) urethroplasty plus tourniquet |
| Non-tourniquet | Experimental | Procedure: Non-tourniquettubularized incided plate (TIP) urethroplasty plus non-tourniquet |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- distal penile hypospadias were eligible for tubularized incided plate (TIP) urethroplasty repair
Key exclusion criteria (5 listed)
- coagulopathy
- sickle cell disease or sickle cell trait
- circumcised patient
- history of previous failed surgery
- severe chordee (>30 degree after degloving).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tourniquettubularized incided plate (TIP) urethroplasty plus tourniquet | Procedure or surgery | Tourniquet |
| Non-tourniquettubularized incided plate (TIP) urethroplasty plus non-tourniquet | Procedure or surgery | Non-tourniquet |
Primary outcome
assess Intraoperative blood loss
Time frame: 12 months
by blood loss in milliliter in used gauze piece
bipolar diathermy use
Time frame: 12 months
by number of bipolar diathermy usage
Surgeon satisfaction about haemostasis
Time frame: 12 months
Surgeon satisfaction 4-tiered questionnaire (very satisfied, satisfied, unsatisfied and very unsatisfied).
2 secondary outcomes
Patient-reported satisfaction
Time frame: 24 months
Long term complication rate
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hypospadias
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Emerging Indications for Hyperbaric Oxygen Treatment
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Evaluating the Efficacy and Safety of Tranexamic Acid in Reducing Perioperative Bleeding During Recurrent Hypospadias Repair.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Dawaba, PhD study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet and Non-tourniquet in people with Hypospadias and Hypospadias, Coronal, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess Intraoperative blood loss (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.