A Novel Suspensory Ligament Penodermal Fixation Technique Versus Dorsal Tunica Albuginea Fixation for Pediatric Buried Penis:

NCT07675915 | Not Yet Recruiting

• 1 other identifier: 36265MS102 / 5/ 26
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Penis/Surgery; Fixation; Ligament

Keywords

Suspensory Ligament; Penodermal; Dorsal Tunica Albuginea Fixation; Pediatric Buried Penis

Outcome Measures

Primary Outcomes (1)

• Evaluate recurrence of buried penis (repair of buried penis)

  2 weeks, 1 month, 3 months, 6 months postoperatively

Secondary Outcomes (1)

• Postoperative complications

  2 weeks, 1 month, 3 months, 6 months

Study Arms (2)

Group A : ( suspensory ligament fixation)

EXPERIMENTAL

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.

Procedure: Group A: Suspensory ligament fixation

Group B: Tunica albuginea fixation

EXPERIMENTAL

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.

Procedure: Group B: Tunica albuginea fixation

Interventions

Group A: Suspensory ligament fixation PROCEDURE

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.

Group A : ( suspensory ligament fixation)

Group B: Tunica albuginea fixation PROCEDURE

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.

Group B: Tunica albuginea fixation

Eligibility Criteria

• Age: 2 Months - 16 Years
• Gender Eligibility Details: Pediatric Males
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children under the age of 18 years diagnosed
• Children with buried penis with parents seeking surgical treatment of this condition.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

Central Study Contacts

Youssef Abdelhamid, Resident

CONTACT

01127728862; yosefgoma99@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)