Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 117 for:    "Penile Disease"

Long Term Outcome of Hypospadias Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02103712
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : April 4, 2014
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

Brief Summary:
Hypospadias is a common congenital abnormality of the penis which affects approximately 1 boy in 250. The opening of the urethra is located on the undersurface of the penis rather than the tip,the foreskin is deficient and there is curvature of the penile shaft in more severe cases. Although the most commonly practised corrective operation ( TIP procedure) gives generally good results, recently published evidence points to a possible long term risk of stenosis ( narrowing of the reconstructed urethra). This comparative study will combine clinical assessment with non invasive measurements of urinary flow to assess the functional outcome of a large series of patients who have undergone hypospadias surgery . The study is primarily designed to answer this question : does a modification of the standard operation which incorporates a skin graft into the reconstructed urethra lead to improved urinary flow and a decreased risk of stenosis? This has not been previously studied . The findings of our study could make an important contribution to improvements in the surgical treatment of boys born with hypospadias.

Condition or disease Intervention/treatment
Hypospadias Other: Qualitative

Layout table for study information
Study Type : Observational
Actual Enrollment : 170 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Outcome of Hypospadias Repair: A Comparative Study
Study Start Date : October 2012
Actual Primary Completion Date : September 2013

Group/Cohort Intervention/treatment
Hypospadias Other: Qualitative



Primary Outcome Measures :
  1. Does a modification of the standard TIP hypospadias operation which incorporates a skin graft into the reconstructed urethra result in improved urinary flow and a (presumed)decrease in the long term risk of stenosis? [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hypospadias
Criteria

Inclusion Criteria:

- 1 Patients with hypospadias who have been treated one of the following two surgical proceduresStandard Tubularised Incised Plate (TIP) operation (Group A) or Tubularised Incised Plate (TIP) procedure incorporating a free graft of preputial skin (in a layer of foreskin) into the urethral reconstruction (Group B ) 2 The study will be confined to primary operations. Patients in whom either of the techniques was used for a secondary or 'redo' procedure will be excluded from the study.

3 The study will be confined to boys over 3 years of age who are potty trained and able to pass urine for the non invasive flow rate test .

Exclusion Criteria:

- 1 Patients whose hypospadias was corrected using some technique other than 'standard' or 'grafted' TIP repair.

2 "Redo" cases 3 Boys under 3 years at the time of the study or patients who do not have full bladder control for some other reason.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103712


Locations
Layout table for location information
United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS1 3EX
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust

Layout table for additonal information
Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02103712     History of Changes
Other Study ID Numbers: UR12/10496
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypospadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities