Foreskin Graft Tubularized Incised Plate Urethroplasty vs Tubularized Incised Plate for Primary Hypospadias (FGTIP-TIP) (FGTIP-TIP)

July 14, 2015 updated by: Byron Pacheco Mendoza, Hospital Infantil de Mexico Federico Gomez

Foreskin Graft Tubularized Incised Plate Urethroplasty (TIP) vs Tubularized Incised Plate (TIP) for Primary Hypospadias. Randomized Clinical Trial (FGTIP-TIP)

The purpose of this study is to determine the efficacy and safety of tubularized incised plate urethroplasty versus foreskin graft tubularized incised plate urethroplasty in primary hypospadias. This study only included patients with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Urethroplasty technique more used in the world for hypospadias repair is Tubularized Incised Plate described by Snodgrass in 1994. Kolon and Gonzales described a technical modification to the TIP in 2000, which is called grafting foreskin.

There are characteristics of the glans and urethral plate favoring the development of complications. In this study the researchers include patients with primary hypospadias, with these characteristics above, and compare two surgical techniques: TIP vs FG-TIP.

The main aim is to determine the efficacy (functional and cosmetic) and safety (complications) of TIP vs FG-TIP.

The study design is a randomized clinical trial, double blind (patient and evaluator), parallel groups.

The sample size was calculated comparing two proportions, with a alpha 0.05, beta 0.2; 34 patients per group. The main outcome is complications.

Study Type

Interventional

Enrollment (Anticipated)

68

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 Contact

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

3 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Patients diagnosed with hypospadias without previous surgery
  • Hypospadias with width of urethral plate ≤ 7 mm, width of glans ≤ 14 mm, and urethral plate depth shallow o moderate.

Exclusion Criteria:

  • Patients diagnosed with hypospadias and severe psychomotor development delay
  • Patients with disorders of sexual development without gender assignment

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Foreskin Graft-Tubularized Incised Plate
Group of patients with primary hypospadias undergoing Foreskin Graft Tubularized Incised Plate Urethroplasty. The surgery involves making an incision on the midline of the urethral plate, graft inner foreskin, and create a new urethra on a urethral catheter.
Procedure: Foreskin Graft-Tubularized Incised Plate
TIP Urethroplasty with foreskin graft in primary hypospadias
Active Comparator: Tubularized Incised Plate
Group of patients with primary hypospadias undergoing Tubularized Incised Plate Urethroplasty. The surgery involves making an incision on the midline of the urethral plate, and create a new urethra on a urethral catheter.
Procedure: Tubularized Incised Plate
TIP Urethroplasty without foreskin graft in primary hypospadias

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with complications as a measure of safety
Time Frame: Fourth month after surgery
Fourth month after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of participants with fistula as a measure of safety
Time Frame: Fourth month after surgery
Fourth month after surgery
Proportion of participants with stricture as a measure of safety
Time Frame: Fourth month after surgery
Fourth month after surgery
Proportion of participants with breakdown as a measure of safety
Time Frame: Fourth month after surgery
Fourth month after surgery

Other Outcome Measures

Outcome Measure
Time Frame
Degree of Cosmetic by HOPE Score as a measure of efficacy
Time Frame: Fourth and sixth months after suregry
Fourth and sixth months after suregry
Urinary mean flow by uroflowmeter as a measure of efficacy
Time Frame: Fourth and sixth months after surgery
Fourth and sixth months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Infantil de Mexico Federico Gomez

Investigators

  • Study Chair: Mario E Rendón Macías, MD MsC, CMNXXI, IMSS
  • Study Director: Onofre Muñoz Hernández, MD MsC, Hospital Infantil de Mexico Federico Gomez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2015

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

June 25, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Estimate)

July 15, 2015

Last Update Submitted That Met QC Criteria

July 14, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIM 2015-079

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.

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