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OpenTrials
Completed

NCT Number: NCT04239066

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

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.

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Key information

Conditions

Hypospadias Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Hypospadia, Repair Hypospadias, Coronal Male Urogenital Diseases Penile Diseases Tourniquet Urogenital Abnormalities Urogenital Diseases

Age range

6 month–36 month

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Urology and nephrology center

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Tourniquet

Procedure

tubularized incided plate (TIP) urethroplasty plus tourniquet

Non-tourniquet

Procedure

tubularized incided plate (TIP) urethroplasty plus non-tourniquet

Primary outcomes

  1. assess Intraoperative blood loss

    Time frame: 12 months

    by blood loss in milliliter in used gauze piece

  2. bipolar diathermy use

    Time frame: 12 months

    by number of bipolar diathermy usage

  3. Surgeon satisfaction about haemostasis

    Time frame: 12 months

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

Secondary outcomes

  1. Patient-reported satisfaction

    Time frame: 24 months

    by hypospadias objective scoring evaluation (HOSE) questionnaire

  2. Long term complication rate

    Time frame: 60 months

    number of surgery related complication after 5 years post operative

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 23, 2020
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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