NCT04239066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

January 20, 2020

Last Update Submit

February 22, 2021

Conditions

HypospadiasHypospadias, CoronalHypospadia, RepairTourniquet

Keywords

TourniquetHypospadias

Outcome Measures

Primary Outcomes (3)

  • assess Intraoperative blood loss

    by blood loss in milliliter in used gauze piece

    12 months

  • bipolar diathermy use

    by number of bipolar diathermy usage

    12 months

  • Surgeon satisfaction about haemostasis

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

    12 months

Secondary Outcomes (2)

  • Patient-reported satisfaction

    24 months

  • Long term complication rate

    60 months

Study Arms (2)

Tourniquet

EXPERIMENTAL

tubularized incided plate (TIP) urethroplasty plus tourniquet

Procedure: Tourniquet

Non-tourniquet

EXPERIMENTAL

tubularized incided plate (TIP) urethroplasty plus non-tourniquet

Procedure: Non-tourniquet

Interventions

TourniquetPROCEDURE

tubularized incided plate (TIP) urethroplasty plus tourniquet

Tourniquet
Non-tourniquetPROCEDURE

tubularized incided plate (TIP) urethroplasty plus non-tourniquet

Non-tourniquet

Eligibility Criteria

Age6 Months - 36 Months
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • distal penile hypospadias were eligible for tubularized incided plate (TIP) urethroplasty repair

You may not qualify if:

  • coagulopathy
  • sickle cell disease or sickle cell trait
  • circumcised patient
  • history of previous failed surgery
  • severe chordee (\>30 degree after degloving).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and nephrology center

Al Mansurah, Outside U.S./Canada, 35516, Egypt

Location

MeSH Terms

Conditions

Hypospadias

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Mohammed Dawaba, PhD

    Mansoura University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 23, 2020

Study Start

September 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

EG(1)