- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07615439
Surgical Repair of Pediatric Concealed Penis is Generally Safe and Efficacious. Criteria for Pediatric Concealed Penis Surgical Success Are Still Poorly Standardized, so Our Study Presents a Multi-dimensional Framework Consisting of Morphometric Measurements and Subjective Psychometric Parameters. (MPPPS SPL BPL)
A Standardized Multidimensional Framework for Long-Term Outcomes Following Pediatric Concealed Penis Repair: A Prospective Cohort Study.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
This prospective cohort study was performed at General Surgery Department of Kafrelsheikh University Hospital between December 2023 and December 2024. The study included 75 pediatric patients (age ranged from 1 to 12 years) diagnosed with concealed penis. We excluded children with micropenis, hypospadius, cryptorchidism, and blood coagulation disorders. Under GA, in the supine position, a 5/0 vicryl traction suture was applied to the glans penis. A circumferential incision was made, leaving about 5 mm of collar mucosa below the coronal sulcus. In subdartos plane, the penis was completely degloved to its base at the peno-pubic angle dorsally and to the peno-scrotal angle ventrally. All dysgenetic dartos attachments were sharply excised using scissors . Hemostasis was maintained using bipolar diathermy. A two-point penile fixation technique was performed utilizing 4/0 PDS (polydioxanone) sutures, as the penile base was anchored to pubic fascia, at 2 and 10 o'clock positions . Then dermis of penile skin is sutured to Buck's fascia at the the penile base and the midshaft using 5/0 PDS sutures on both sides of the dorsal neurovascular bundle. Following the excision of redundant preputial skin, the remaining skin was approximated to collar mucosa by interrupted 6/0 Vicryl stitches . A compression dressing soaked with antibiotic cream was applied and kept for 2 days. Patients were discharged on the day of surgery, with a prescription for oral non-steroidal anti-inflammatory drug (NSAIDs), scheduled for the initial outpatient clinic visit after two days for dressing removal and the initiation of topical antibiotic cream (three times daily). A second evaluation was performed at the end of the first postoperative week to monitor early recovery and detect any immediate complications as penile edema, wound hematoma or infection. Longitudinal assessment was maintained via monthly visits for a total duration of one year. This standardized follow-up facilitated consistent collection of morphometric measurements and psychometric assessment of parental perceptions and satisfaction scores.
Evaluation A. Quantitative Morphometric Assessment: Pre and post-operative measurements of baseline penile length (BPL), and the stretched penile length (SPL) were recorded. The Concealed Index (CI), calculated as the ratio of BPL to SPL, was utilized as a standardized morphometric evaluating parameter. It was calculatedd and recorded at three intervals; preoperatively, immediately postoperatively, and at the one-year follow-up to assess both immediate gains and long-term durability.
B. Evaluation of parental perception and satisfaction: Parent-reported outcomes were evaluated at the one-year follow-up mark, using two validated psychometric parameters introduced to parents to assess their feedback and satisfaction level: The first tool was the Buried Penis Questionnaire: a pre-approved questionnaire was applied to evaluate the functional outcomes of the surgical repair as penile length improvement, maintainance of hygiene, resolution of urination difficulties and parental psychosocial burden alleviation. The second was the Modified Paediatric Penile Perception Score (MPPPS)to assess hypospadias repair outcomes, and then was modified to evaluate aesthetic outcomes of concealed penis correction. This tool evaluates three domains: penile length, appearance of penile skin, and overall penile appearance. Each domain was quantified using a 4-point scale (0-3), where 0 denotes 'very dissatisfied', 1 'dissatisfied', 2 'satisfied', and 3 'very satisfied'. Total score (0-9) provided a metric for assessing parental satisfaction with long-term surgical outcome.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Kafr ash Shaykh, Egypt, 33516
- Omar Afandy
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- children diagnosed with concealed penis, age ranged from 1 to 12 years
Exclusion Criteria:
- children with micropenis, hypospadius, cryptorchidism, and blood coagulation disorders.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The immediate postoperative period
Tidsramme: 1-2 weeks
|
number of participants with postoperative penile skin edema
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1-2 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The longterm postoperative results
Tidsramme: 1 year
|
number of participants with secondary penile retraction in the long-term
|
1 year
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Approval Number. KFSIRB200-351
Plan for individuelle deltakerdata (IPD)
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