Abstract 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.
Introduction Early screening of children at-risk to develop Autism Spectrum Disorder (ASD) needs to be improved to propose early interventions. This detection should allow diagnosis of ASD before the age of 3. An early screening performed at the general practitioner of the family should facilitate accessibility to diagnosis and a better collaboration between professionals. Objectives Our primary objective is to estimate the positive predictive value of an early detection kit composed of 2 questionnaires (First screening: M-CHAT-R/F™ + CSBS DP™-ITC) and a confirmation of the detection with a phone call by a neuropsychologist. Patients with confirmed positive M-CHAT-R/F™ and/or CSBS DP™-ITC scores are referred to a level 2 team for pre-diagnosis and diagnosis assessment. Methods The KitCAT study is a cohort study of 1,700 children aged 16 to 24 months seen in routine care in general or pediatric practices, or in nurseries and child care centers. Results Seven hundred and five children have already been enrolled in the study. Twenty nine patients, ie 4.1%, (with a confirmed positive M-CHAT-R/F™ and/or CSBS DP™-ITC scores) were referred to a level 2 team where a pre-diagnosis assessment was conducted by using the following test: ADI-R, ADOS 2, BLR, WPPSI-IV and Vineland II. The diagnosis of ASD (using the same test than the pre-diagnosis) was confirmed for the first two patients aged of 3. Conclusions The preliminary results confirm that the use of 2 questionnaires may optimize the reliability of the screening. A thousand children are still needed for the final analysis and further results are expected. Disclosure No significant relationships.
