Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty
Primary Purpose
Urethral Stricture
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Labial Graft
Jugal Graft
Sponsored by
About this trial
This is an interventional treatment trial for Urethral Stricture focused on measuring urethral stricture, mucosa graft, jugal graft,, labial graft, success rate
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Labial
Jugal
Arm Description
Patients who received a labial graft as replacement of urethral tissue
Patients who received a jugal (inner cheek) graft as replacement of urethral tissue
Outcomes
Primary Outcome Measures
Overall Success Rate
Absence of surgical intervention after prior surgery
Labial Group Success Rate
Absence of surgical intervention after prior surgery on patients who received a labial graft.
Jugal Group Success Rate
Absence of surgical intervention after prior surgery on patients who received a inner cheek graft.
Latex Catheter Success Rate
Absence of surgical intervention on patients who used a latex catheter indwelling after prior surgery.
Silicon Catheter Success Rate
Absence of surgical intervention on patients who used a silicon catheter indwelling after prior surgery.
Secondary Outcome Measures
Stricture Etiology
Evaluation of the etiology of the stricture (trauma, other, infectious) on patients included on Labial and Jugal Groups
Stricture Localization
Evaluation of the stricture localization (penile, bulbar/bulbomembranous or combined) on patients included on Labial and Jugal Groups
Stricture Size
Evaluation of the stricture length (cm) on patients included on Labial and Jugal Groups
Demographic Data
Evaluation of the demographic data relationship with the results (age, cystotomy, cystostomy time, tobacco use, diabetes, balanitis xerotica, UTI infection, serum creatin levels) included on Labial and Jugal groups
Full Information
NCT ID
NCT03973619
First Posted
May 15, 2019
Last Updated
August 20, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT03973619
Brief Title
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2016 (Actual)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
November 27, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethral Stricture
Keywords
urethral stricture, mucosa graft, jugal graft,, labial graft, success rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Labial
Arm Type
Active Comparator
Arm Description
Patients who received a labial graft as replacement of urethral tissue
Arm Title
Jugal
Arm Type
Active Comparator
Arm Description
Patients who received a jugal (inner cheek) graft as replacement of urethral tissue
Intervention Type
Procedure
Intervention Name(s)
Labial Graft
Intervention Description
As replacement of the damaged urethral tissue, we used a buccal mucosa graft (labial graft).
Intervention Type
Procedure
Intervention Name(s)
Jugal Graft
Intervention Description
As replacement of the damaged urethral tissue, we used a buccal mucosa graft(inner cheek - jugal graft).
Primary Outcome Measure Information:
Title
Overall Success Rate
Description
Absence of surgical intervention after prior surgery
Time Frame
6 months
Title
Labial Group Success Rate
Description
Absence of surgical intervention after prior surgery on patients who received a labial graft.
Time Frame
6 months
Title
Jugal Group Success Rate
Description
Absence of surgical intervention after prior surgery on patients who received a inner cheek graft.
Time Frame
6 months
Title
Latex Catheter Success Rate
Description
Absence of surgical intervention on patients who used a latex catheter indwelling after prior surgery.
Time Frame
6 months
Title
Silicon Catheter Success Rate
Description
Absence of surgical intervention on patients who used a silicon catheter indwelling after prior surgery.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Stricture Etiology
Description
Evaluation of the etiology of the stricture (trauma, other, infectious) on patients included on Labial and Jugal Groups
Time Frame
24 months
Title
Stricture Localization
Description
Evaluation of the stricture localization (penile, bulbar/bulbomembranous or combined) on patients included on Labial and Jugal Groups
Time Frame
24 months
Title
Stricture Size
Description
Evaluation of the stricture length (cm) on patients included on Labial and Jugal Groups
Time Frame
24 months
Title
Demographic Data
Description
Evaluation of the demographic data relationship with the results (age, cystotomy, cystostomy time, tobacco use, diabetes, balanitis xerotica, UTI infection, serum creatin levels) included on Labial and Jugal groups
Time Frame
24 months
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brasil S Neto, Phd MD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
16094007
Citation
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Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty
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