NCT06260241

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

December 11, 2023

Last Update Submit

February 14, 2024

Conditions

Concealed Penis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

With Traction Dressing

OTHER

Traction dressing will be applied to patients after phalloplasty for 24 hours.

Procedure: Traction Dressing

Without Traction Dressing

OTHER

No traction dressing will be applied to patients after phalloplasty for 24 hours.

Other: Without Traction Dressing

Interventions

Traction DressingPROCEDURE

Traction dressing will be applied to one group for 24 hours and simple dressing to the other group.

With Traction Dressing
Without Traction DressingOTHER

Without Traction Dressing

Without Traction Dressing

Eligibility Criteria

Age4 Years - 13 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infants and children aged 4 years to 13 years of age.
  • Presenting with concealed penis for circumcision.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheikh Zayed Hospital

Lahore, Punjab Province, Pakistan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 11226987RESULT

  • 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.

    PMID: 24528990RESULT

  • 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.2017.07.021. Epub 2017 Aug 7.

    PMID: 28797684RESULT

  • 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.

    PMID: 31380232RESULT

  • 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.

    PMID: 30211051RESULT

Study Officials

  • MUHAMMAD ALI SHEIKH, MBBS FCPS

    SHEIKH ZAYED HOSPITAL

    STUDY CHAIR

Central Study Contacts

ADEEL AHMED, MBBS MS

CONTACT

00923334958574aadeel93@hotmail.com

MUHAMMAD ALI SHEIKH, MBBS FCPS

CONTACT

00923214790094drali444@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
POST GRADUATE RESIDENT

Study Record Dates

First Submitted

December 11, 2023

First Posted

February 15, 2024

Study Start

January 1, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)