- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Kafr ash Shaykh, Egypten, 33516
- Omar Afandy
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
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 undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The immediate postoperative period
Tidsramme: 1-2 weeks
|
number of participants with postoperative penile skin edema
|
1-2 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The longterm postoperative results
Tidsramme: 1 year
|
number of participants with secondary penile retraction in the long-term
|
1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Approval Number. KFSIRB200-351
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Skjult penis
-
University of PittsburghIkke rekrutterer endnuPenis/kirurgi | Penis/skader | Penile hud | Voksen-erhvervet begravet penisForenede Stater
-
Shaikh Zayed Hospital, LahoreRekrutteringSkjult penisPakistan
-
University of StellenboschAfsluttet
-
Hôpital d'enfants Béchir-HamzaAfsluttet
-
Centre Hospitalier Universitaire de NiceIkke rekrutterer endnu
-
Sir Run Run Shaw HospitalAfsluttet
-
Cairo UniversityUkendtPenis protese; KomplikationerEgypten
-
Institute of Cancer Research, United KingdomNational Cancer Institute (NCI); ECOG-ACRIN Cancer Research GroupRekrutteringPlanocellulært karcinom i penis, sædvanlig typeForenede Stater, Det Forenede Kongerige
-
CHA MEDITECH Co., Ltd.AfsluttetPenisforstærkning | Lille penisKorea, Republikken
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...RekrutteringPeyronies sygdom | Penis krumning | Navlestrengsblod | Randomiseret klinisk forsøg | Penis injektionsterapi | PRP injektionItalien