- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07675915
A Novel Suspensory Ligament Penodermal Fixation Technique Versus Dorsal Tunica Albuginea Fixation for Pediatric Buried Penis:
A Novel Suspensory Ligament Penodermal Fixation Technique Versus Dorsal Tunica Albuginea Fixation for Pediatric Buried Penis: A Prospective Comparative Cohort Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Buried penis is a congenital penile anomaly in which the penile shaft is hidden beneath the surrounding skin and subcutaneous tissues, despite having a normal-sized underlying structure. It is a relatively uncommon condition in children, but it is clinically significant due to its functional, hygienic, and psychological consequences. Reported incidence varies across populations. The condition is often underrecognized or misdiagnosed, particularly in early childhood .
The etiology of buried penis is multifactorial and not yet fully understood. Several mechanisms have been proposed, including deficient or inelastic penile shaft skin, abnormal fixation of dartos fascia, and inadequate attachment between the penile skin and underlying Buck's fascia. Excess prepubic fat and abnormal ventral displacement of the penis may further contribute to its buried appearance. Additionally, fibrous tethering bands between fascial layers have been implicated in anchoring the penis within surrounding tissues .
Clinically, buried penis presents with variable severity ranging from a partially visible "stumpy" penile shaft to complete concealment beneath the suprapubic or scrotal tissue. Children often present with parental concern regarding penile size, hygiene difficulties, and functional urinary problems. These may include urine spraying, recurrent balanitis, urinary tract infections, and difficulty voiding in a standing position. In more severe or prolonged cases, psychological distress and body image concerns may develop .
Buried penis should be differentiated from other penile conditions such as micropenis, webbed penis, and trapped penis, as each has distinct anatomical and pathological features. Misclassification may lead to inappropriate management strategies and suboptimal outcomes. Accurate clinical assessment is therefore essential, often relying on physical examination and careful evaluation of penile skin deficiency, fascial attachments, and surrounding adiposity. Early diagnosis is important to prevent progressive functional and psychosocial complications .
Surgical correction remains the mainstay of treatment for buried penis, especially in symptomatic or persistent cases. The primary goals of surgery are to achieve adequate penile exposure, restore normal anatomy, and improve both functional and cosmetic outcomes. Multiple surgical techniques have been described; However, no single standardized technique has been universally accepted .
Penodermal fixation sutures utilizing suspensory ligament is a technique used as a complete penile degloving and release of abnormal dartos bands in children with buried penis occurs. Fixation sutures are placed between the penile dermis and the suspensory ligament at the penile base to maintain shaft exposure and recreate normal penopubic angles. It provides stable support, decreases postoperative retraction, and improves cosmetic appearance with low recurrence rates. Recent studies support fixation-based methods as safe and effective options in pediatric buried penis repair .
Another technique is called dorsal tunica albuginea sutures, after penile degloving and release of tethering tissues, fixation sutures are placed between the dermis or subcutaneous tissue and the dorsal tunica albuginea of the penile shaft. The tunica serves as a strong anchoring structure to maintain externalization of the penis. This approach helps secure shaft skin position and reduces recurrence of concealment. It is considered effective with good functional and cosmetic results.
The aim of the work to compare the outcomes of suspensory ligament fixation to the sub-dermis and dorsal tunica albuginea fixation in terms of success rate, need for auxiliary procedures, and complication rates in the buried penis.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Youssef Abdelhamid, Resident
- Phone Number: 01127728862
- Email: yosefgoma99@gmail.com
Study Locations
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-
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Tanta, Egypt
- Tanta University
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Contact:
- Youssef Abdelhamid, Resident
- Phone Number: 01127728862
- Email: yosefgoma99@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children under the age of 18 years diagnosed
- Children with buried penis with parents seeking surgical treatment of this condition.
Exclusion Criteria:
- History of previous penile surgery.
- Patients with micro-penis.
- Patients with other congenital anomalies such as hypospadias, epispadias and cryptorchidism.
- Uncontrolled bleeding diathesis or patient who isn't fit for general anesthesia.
- Buried penis due to excessive obesity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A : ( suspensory ligament fixation)
All patients will receive a prophylactic antibiotic before beginning of the procedure. The operative area will be cleaned with 10% povidine iodine and draped in sterile manner. We will perform the procedure in the supine position. The technique consists of complete degloving of the penis with release of any tethering tissues and exposure of the suspensory ligament at the base of the penile shaft. The suspensory ligament is identified, and fixation suture is placed between the ligament and the deep subdermal layer of the suprapubic skin without involving the tunica albuginea. This suture is positioned to secure the penile base and maintain a stable penopubic angle, helping to prevent retraction. Care is taken to ensure appropriate depth and tension of the sutures to avoid over-tightening, followed by re-draping and closure of the skin. This will also be associated with placement of 2 fixation sutures at the penoscrotal junction to identify Penoscrotal angle. |
All patients will receive a prophylactic antibiotic before beginning of the procedure. The operative area will be cleaned with 10% povidine iodine and draped in sterile manner. We will perform the procedure in the supine position. The technique consists of complete degloving of the penis with release of any tethering tissues and exposure of the suspensory ligament at the base of the penile shaft. The suspensory ligament is identified, and fixation suture is placed between the ligament and the deep subdermal layer of the suprapubic skin without involving the tunica albuginea. This suture is positioned to secure the penile base and maintain a stable penopubic angle, helping to prevent retraction. Care is taken to ensure appropriate depth and tension of the sutures to avoid over-tightening, followed by re-draping and closure of the skin. This will also be associated with placement of 2 fixation sutures at the penoscrotal junction to identify Penoscrotal angle. |
|
Experimental: Group B: Tunica albuginea fixation
All patients will receive prophylactic antibiotics before the beginning of the procedure. Operative area will be cleaned with 10% povidone iodine and draped in sterile manner. We will perform the procedure in supine position, The technique consists of complete degloving of the penis and release of any tethering tissues, exposure of the base of the penile shaft. Sutures are then placed between the tunica albuginea on the dorsal aspect of the penile base and the deep dermal (subdermal) layer of the suprapubic skin in the direction of 3 and 9 o'clock to avoid the neurovascular bundle. These sutures are positioned symmetrically to secure the penile shaft in a fixed position relative to the overlying skin. Care is taken to place the sutures at an appropriate depth and tension, followed by re-draping and closure of the skin. This will also be associated with placement of 2 fixation sutures at the penoscrotal junction to identify penoscrotal angle. |
All patients will receive prophylactic antibiotics before the beginning of the procedure. Operative area will be cleaned with 10% povidone iodine and draped in sterile manner. We will perform the procedure in supine position, The technique consists of complete degloving of the penis and release of any tethering tissues, exposure of the base of the penile shaft. Sutures are then placed between the tunica albuginea on the dorsal aspect of the penile base and the deep dermal (subdermal) layer of the suprapubic skin in the direction of 3 and 9 o'clock to avoid the neurovascular bundle. These sutures are positioned symmetrically to secure the penile shaft in a fixed position relative to the overlying skin. Care is taken to place the sutures at an appropriate depth and tension, followed by re-draping and closure of the skin. This will also be associated with placement of 2 fixation sutures at the penoscrotal junction to identify penoscrotal angle. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluate recurrence of buried penis (repair of buried penis)
Time Frame: 2 weeks, 1 month, 3 months, 6 months postoperatively
|
2 weeks, 1 month, 3 months, 6 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Postoperative complications
Time Frame: 2 weeks, 1 month, 3 months, 6 months
|
2 weeks, 1 month, 3 months, 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- 36265MS102 / 5/ 26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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