- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kafr ash Shaykh, Egypt, 33516
- Omar Afandy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The immediate postoperative period
Time Frame: 1-2 weeks
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number of participants with postoperative penile skin edema
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1-2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The longterm postoperative results
Time Frame: 1 year
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number of participants with secondary penile retraction in the long-term
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1 year
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Approval Number. KFSIRB200-351
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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