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

Primary Purpose

Hypospadias, Hypospadias, Coronal, Hypospadia, Repair

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Tourniquet

Non-tourniquet

About this trial

This is an interventional treatment trial for Hypospadias focused on measuring Tourniquet, Hypospadias

Eligibility Criteria

6 Months - 36 Months (Child)MaleDoes not accept 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).

Sites / Locations

Urology and nephrology center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Tourniquet

Non-tourniquet

Arm Description

tubularized incided plate (TIP) urethroplasty plus tourniquet

tubularized incided plate (TIP) urethroplasty plus non-tourniquet

Outcomes

Primary Outcome Measures

assess Intraoperative blood loss

by blood loss in milliliter in used gauze piece

bipolar diathermy use

by number of bipolar diathermy usage

Surgeon satisfaction about haemostasis

Surgeon satisfaction 4-tiered questionnaire (very satisfied, satisfied, unsatisfied and very unsatisfied).

Secondary Outcome Measures

Patient-reported satisfaction

by hypospadias objective scoring evaluation (HOSE) questionnaire

Long term complication rate

number of surgery related complication after 5 years post operative

Full Information

NCT ID

NCT04239066

First Posted

January 20, 2020

Last Updated

February 22, 2021

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT04239066

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

December 1, 2018 (Actual)

Study Completion Date

December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypospadias, Hypospadias, Coronal, Hypospadia, Repair, Tourniquet

Keywords

Tourniquet, Hypospadias

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

110 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tourniquet

Arm Type

Experimental

Arm Description

tubularized incided plate (TIP) urethroplasty plus tourniquet

Arm Title

Non-tourniquet

Arm Type

Experimental

Arm Description

tubularized incided plate (TIP) urethroplasty plus non-tourniquet

Intervention Type

Procedure

Intervention Name(s)

Tourniquet

Intervention Description

tubularized incided plate (TIP) urethroplasty plus tourniquet

Intervention Type

Procedure

Intervention Name(s)

Non-tourniquet

Intervention Description

tubularized incided plate (TIP) urethroplasty plus non-tourniquet

Primary Outcome Measure Information:

Title

assess Intraoperative blood loss

Description

by blood loss in milliliter in used gauze piece

Time Frame

12 months

Title

bipolar diathermy use

Description

by number of bipolar diathermy usage

Time Frame

12 months

Title

Surgeon satisfaction about haemostasis

Description

Surgeon satisfaction 4-tiered questionnaire (very satisfied, satisfied, unsatisfied and very unsatisfied).

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Patient-reported satisfaction

Description

by hypospadias objective scoring evaluation (HOSE) questionnaire

Time Frame

24 months

Title

Long term complication rate

Description

number of surgery related complication after 5 years post operative

Time Frame

60 months

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

36 Months

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammed Dawaba, PhD

Organizational Affiliation

Mansoura University

Official's Role

Study Director

Facility Information:

Facility Name

Urology and nephrology center

City

Mansoura

State/Province

Outside U.S./Canada

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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