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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023686-22 | EudraCT Number |
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Hypospadias is a congenital abnormality of the penis that is caused by incomplete development of the anterior urethra. This pathology is one of the most common genital anomalies in paediatric urology .The incidence is reported to be 1 out of 250 live male births and is increasing regularly. The hypospadias surgeries present a high risk of post operative complications requiring re-interventions.
A great part of the post operative complications is related to imperfect healing issues. If androgen stimulation seems to be deleterious, at the opposite, oestrogen could impact positively on the skin healing process. This point leads to the hypothesis that local transcutaneous oestrogen stimulation on the ventral and dorsal penile faces decreases the number of skin healing post-operative defects.
The objective of the study is to assess the effect of oestrogen (applied once daily for 2 months prior to surgery) on the post-operative complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| promestriene | Experimental | Children with severe hypospadias treated with promestriene 1% |
|
| Placebo | Placebo Comparator | Control group, children with severe hypospadias treated with Placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| promestriene | Drug | Promestriene cream 1%, 1g per day during 2 months, cutaneous application |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patient with postoperative urethral fistula and dehiscence | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Re-intervention related to wound healing | Number of re-interventions for fistula or dehiscence not related to stenosis, in the first year post surgery. | 1 year |
| post-surgical complications | Total number and type of post-surgical complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Mouriquand, Prof | HOPITAL FEMME MERE ENFANT CHU DE LYON | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Pédiatrique Uro-génitale, Hopital femme Mere Enfant | Bron | 69677 | France | |||
| Hôpital Mère-Enfant |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32386308 | Result | Gorduza D, Plotton I, Remontet L, Gay CL, El Jani M, Cheikhelard A, Blanc T, El Ghoneimi A, Leclair MD, Roy P, Pirot F, Mimouni Y, Gaillard S, Chatelain P, Morel Y, Kassai B, Mouriquand P. Preoperative Topical Estrogen Treatment vs Placebo in 244 Children With Midshaft and Posterior Hypospadias. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa231. doi: 10.1210/clinem/dgaa231. |
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| Placebo | Drug | Placebo of promestriene cream, 1g per day during 2 months, cutaneous application |
|
| Urethroplasty | Procedure | Onlay-tube-onlay urethroplasty performed by a physician expert of this technique (at least 5 years of practical ability) |
|
| Wrist X ray | Radiation | Wrist X ray to follow the degree of bone maturation |
|
| Blood test | Procedure | Hormonal dosage: Oestradiol, testosterone, FSH-LH and AMH |
|
| 1 year |
| Re-intervention not related to wound healing | Number of re-interventions not related to wound healing | 1 year |
| Hormone measurement | Plasmatic concentrations of Oestradiol, Testosterone, LH, FSH at inclusion and at 2 months (at the end of study treatment) | 2 months |
| Bone age evaluation | Hand and wrist radiography at inclusion and 1 year after surgery. | 14 monthes |
| Clinical tolerance of the treatment | Number and type of adverse events | 14 months |
| Nantes |
| 44093 |
| France |
| Hôpital Robert Debré | Paris | 72015 | France |
| Hôpital NECKER | Paris | 75015 | France |
| ID | Term |
|---|---|
| D007021 | Hypospadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C013657 | promestriene |
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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