Long Term Follow-up for Hypospadias
- Conditions
- Hypospadias
- Interventions
- Procedure: clinical and paraclinical examination
- Registration Number
- NCT04142632
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
Hypospadias is a frequent malformation. The definition of hypospadias is a ventral tissues hypoplasia, with an abnormal position of the urethral meatus, a chordee of the penis and an open foreskin. It can be associate with other genital malformation; in that case it can be classified in the wider field of the disorder of sex development (DSD). There is a lot of surgical technics for those malformations.
In the pediatric surgical department, in Lyon, three technics are the most used because of their reliability and their good outcomes in short and mid term.
This is essential for investigator to have a long term evaluation, with a physical exam and paraclinical exams, after the puberty, to assess the outcomes after the changes especially at the puberty.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 300
- Male patients
- with previous hypospadias surgery,
- Birthday before December the 31th 2009.
- The surgery was performed by one operator, with the following surgical technics: Koff, Onlay and Koyanagi.
- The patients are informed by an official surgery department letter, to assure they agree to participate.
- if the patient is still an infant, the parental agreement will be necessary.
- Patient deceased
- Non- agreement from the patient or his parents
- Language difficulties
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description long term evaluation of hypospadias surgery clinical and paraclinical examination -
- Primary Outcome Measures
Name Time Method Event Free Survival Day 0 Time with no complication after the last surgery for hypospadias
- Secondary Outcome Measures
Name Time Method patient satisfaction day 0 The investigator will do an interrogation of the patient about his personal satisfaction, the response will be yes or no.
Penis size Day 0 Urinary symptoms Day 0 The investigator will do an interrogation of the patient about urinary symptoms, the response will be yes or no.
quality of the urinary flow: straight or not straight Day 0 sexual activity Day 0 The investigator will do an interrogation of the patient about sexual activity, the response will be yes or no.
occurrence of urinary infection Day 0 Pre-voiding bladder volume Day 0 post-voiding bladder volume Day 0 Flow measurement Day 0 The investigator will use an urinary flowmeter; the investigator will collect data with a curve for each patient, with time in x-axis and ml/s in y-axis.
occurrence of ejaculation Day 0 occurrence of erection Day 0 puberty clinical signs Day 0 The investigator will use the tanner's criteria during the physical examination.
Stages of genital \[G\] and pubic hair \[Ph\] development in the male. G-1, Ph-1: pre-pubertal; G-2: the testis and scrotum enlarge, and the skin of the scrotum shows some reddening and change in the texture. Sparse growth of pigmented hair usually slightly curly, mainly at the base of the penis (Ph-2); G-3: Testis and scrotum enlarge further, the penis grows mainly in length but also in breadth. The hair is darker, coarser and curlier and spreads over the junction of the pubes (Ph-3); G-4: Scrotum, testis, and penis grow further with development of the glans, and further darkening of the scrotal skin. The hair spreads covering the pubes; G-5: adult stage with spreading of the hair to the medial surface of the thighs (Ph-5).endocrine disorder Day 0 Testicular ultrasonography day 0 The investigator will ask a testicular ultrasonography which will be performed by a radiologist, the following data will be collected: testicular volume, aspect of the testicular parenchyma.
Trial Locations
- Locations (1)
Service de chirurgie uro-viscérale, thoracique et de transplantation de l'enfant Hôpital Femme Mère Enfant
🇫🇷Bron, France