Clinical trial NCT03973619: Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty
Official title: Urethral Stricture Repair: A Prospective Randomized Analysis Between Jugal or Labial Graft in Buccal Mucosa Urethroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urethral Stricture
Keywords: urethral stricture
mucosa graft
jugal graft,
labial graft
success rate
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2019-06-04
Enrollment: 77
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Buccal mucosa urethroplasty is a current fashion in urethral stricture management. In our university centre (Hospital de Clínicas de Porto Alegre) is a common surgical treatment choice. This paper aims to evaluate the success rate of this treatment after randomized choice between labial and jugal (inner cheek) grafts during the past two years.

Detailed description: Free dorsal graft urethroplasty, first described by Barbagli et al, has been shown better results than ventral grafts. Fixed grafts on the corpora cavernosa results in a better mechanical support and vascular supply, with less chance to complications such as pseudodiverticula and sacculations either a better urethral phisiology.

This study aims to evaluate the current surgical management in our centre: buccal mucosa graft urethroplasty with jugal or labial replacement, comparing their group success rate and complications between the groups in patients led to surgery from October 2016 to June 2018.

Prospective analysis from urethral stricture surgical HCPA patient data by dorsal buccal mucosa graft urethroplasty. The graft choice were done by a software. Longer stricture with transoperative need for the two grafts use were excluded. Success rate were measured with a no stricture de novo or absence of complications in a six month interval.

Eligibility criteria: Inclusion Criteria:

* Urethral Stricture Diagnosis
* Indication for buccal mucosa graft urethroplasty
* Accept the Informed Consent Term (patient or responsible)

Exclusion Criteria:

* Severe urethral stricture which a two-staged procedure are required
* Long strictures which need a both types of buccal mucosa graft due its length.
* Refuse to ICT for the patient ou it responsible

Primary outcomes:
measure: Overall Success Rate
timeFrame: 6 months
measure: Labial Group Success Rate
timeFrame: 6 months
measure: Jugal Group Success Rate
timeFrame: 6 months
measure: Latex Catheter Success Rate
timeFrame: 6 months
measure: Silicon Catheter Success Rate
timeFrame: 6 months
Secondary outcomes:
measure: Stricture Etiology
timeFrame: 24 months
measure: Stricture Localization
timeFrame: 24 months
measure: Stricture Size
timeFrame: 24 months
measure: Demographic Data
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital de Clinicas de Porto Alegre
name: Brasil S Neto, Phd MD
role: PRINCIPAL_INVESTIGATOR
References:
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