Preoperative Topical Estrogen Treatment vs Placebo in 244 Children With Midshaft and Posterior Hypospadias Article Swipe
Daniela Gorduza
,
Ingrid Plotton
,
Laurent Remontet
,
Claire-Lise Gay
,
Meriem El Jani
,
Alaa Cheikhelard
,
Thomas Blanc
,
Alaa El‐Ghoneimi
,
Marc‐David Leclair
,
Pascal Roy
,
Fabrice Pirot
,
Yanis Mimouni
,
Ségolène Gaillard
,
Pierre Chatelain
,
Yves Morel
,
Behrouz Kassaï
,
Pierre Mouriquand
·
YOU?
·
· 2020
· Open Access
·
· DOI: https://doi.org/10.1210/clinem/dgaa231
YOU?
·
· 2020
· Open Access
·
· DOI: https://doi.org/10.1210/clinem/dgaa231
Purpose Urethral fistula and dehiscence are common after hypospadias surgery. Preoperative androgens have been considered to reduce these complications although this consideration is not evidence-based. Dermatologists have reported the benefits of topical estrogens on skin healing. We investigated whether the preoperative use of topical promestriene could reduce healing complications in hypospadias surgery. Our primary objective was to demonstrate a reduction of healing complications with promestriene vs placebo. Impact on reoperations and other complications, clinical tolerance, bone growth, and biological systemic effects of the treatment were also considered. Methods We conducted a prospective, randomized, placebo-controlled, double-blind, parallel group trial between 2011 and 2015 in 4 French centers. One-stage transverse preputial island flap urethroplasty (onlay urethroplasty) was selected for severe hypospadias. Promestriene or placebo was applied on the penis for 2 months prior to surgery. The primary outcome was the presence of postoperative urethral fistula or dehiscence in the first year postsurgery. For safety reasons, hormonal and anatomical screenings were performed. Results Out of 241 patients who received surgery, 122 patients were randomized to receive placebo, and 119 patients received promestriene. The primary outcome was unavailable for 11 patients. Healing complications were assessed at 16.4% (19/116) in the placebo vs 14.9% (17/114) in the promestriene arm, and the odds ratio adjusted on center was 0.93 (95% confidence interval 0.45-1.94), P = 0.86. Conclusions and relevance Although we observed an overall lower risk of complications compared to previous publications, postsurgery complications were not different between promestriene and placebo, because of a lack of power of the study or the inefficacy of promestriene.
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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1210/clinem/dgaa231
- https://academic.oup.com/jcem/article-pdf/105/7/2422/33555086/dgaa231.pdf
- OA Status
- bronze
- Cited By
- 8
- References
- 37
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W3023295544
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W3023295544Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1210/clinem/dgaa231Digital Object Identifier
- Title
-
Preoperative Topical Estrogen Treatment vs Placebo in 244 Children With Midshaft and Posterior HypospadiasWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2020Year of publication
- Publication date
-
2020-05-09Full publication date if available
- Authors
-
Daniela Gorduza, Ingrid Plotton, Laurent Remontet, Claire-Lise Gay, Meriem El Jani, Alaa Cheikhelard, Thomas Blanc, Alaa El‐Ghoneimi, Marc‐David Leclair, Pascal Roy, Fabrice Pirot, Yanis Mimouni, Ségolène Gaillard, Pierre Chatelain, Yves Morel, Behrouz Kassaï, Pierre MouriquandList of authors in order
- Landing page
-
https://doi.org/10.1210/clinem/dgaa231Publisher landing page
- PDF URL
-
https://academic.oup.com/jcem/article-pdf/105/7/2422/33555086/dgaa231.pdfDirect link to full text PDF
- Open access
-
YesWhether a free full text is available
- OA status
-
bronzeOpen access status per OpenAlex
- OA URL
-
https://academic.oup.com/jcem/article-pdf/105/7/2422/33555086/dgaa231.pdfDirect OA link when available
- Concepts
-
Medicine, Urethroplasty, Hypospadias, Placebo, Surgery, Dehiscence, Odds ratio, Randomized controlled trial, Fistula, Urethra, Internal medicine, Pathology, Alternative medicineTop concepts (fields/topics) attached by OpenAlex
- Cited by
-
8Total citation count in OpenAlex
- Citations by year (recent)
-
2025: 1, 2024: 1, 2023: 4, 2022: 1, 2021: 1Per-year citation counts (last 5 years)
- References (count)
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37Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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