Concealed Penis Clinical Trial
Official title:
Gain in Stretched Penile Length After Phalloplasty With & Without Penile Traction in Children.
The goal of this Randomized Controlled Trial is to assess the gain in stretched penile length after phalloplasty with & without penile traction in children of age group 4 to 13 years presenting in hospital with the complaint of concealed penis. The main question[s] it aims to answer is: • Gain in stretched penile length after phalloplasty with and without penile traction in children.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | January 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 4 Years to 13 Years |
Eligibility | Inclusion Criteria: - Infants and children aged 4 years to 13 years of age. - Presenting with concealed penis for circumcision. Exclusion Criteria: - Congenital Buried Penis - Webbed penis - Structural abnormalities of the penis such as hypospadias, Epispadias etc. - Existing co-morbid syndromes or conditions - Unfit for general anesthesia - Known bleeding diathesis - Incomplete foreskin - Any previous penile surgery |
Country | Name | City | State |
---|---|---|---|
Pakistan | Sheikh Zayed Hospital | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
Shaikh Zayed Hospital, Lahore |
Pakistan,
Brisson P, Patel H, Chan M, Feins N. Penoplasty for buried penis in children: report of 50 cases. J Pediatr Surg. 2001 Mar;36(3):421-5. doi: 10.1053/jpsu.2001.21605. — View Citation
Hadidi AT. Buried penis: classification surgical approach. J Pediatr Surg. 2014 Feb;49(2):374-9. doi: 10.1016/j.jpedsurg.2013.09.066. Epub 2013 Nov 7. — View Citation
Hampson LA, Muncey W, Chung PH, Ma CC, Friedrich J, Wessells H, Voelzke BB. Surgical and Functional Outcomes Following Buried Penis Repair With Limited Panniculectomy and Split-thickness Skin Graft. Urology. 2017 Dec;110:234-238. doi: 10.1016/j.urology.20 — View Citation
Heston AL, Esmonde NO, Dugi DD 3rd, Berli JU. Phalloplasty: techniques and outcomes. Transl Androl Urol. 2019 Jun;8(3):254-265. doi: 10.21037/tau.2019.05.05. — View Citation
Ho TS, Gelman J. Evaluation and management of adult acquired buried penis. Transl Androl Urol. 2018 Aug;7(4):618-627. doi: 10.21037/tau.2018.05.06. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The gain in stretched penile length (SPL) | To measure the gain in stretched penile length (SPL) following phalloplasty with and without penile traction applied for 24 hours for patients undergoing surgery for concealed penis at two weeks post-operatively. | up to 2 Years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04755803 -
A Prospective Registry of Patients With Congenital Penile Anomalies
|