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NCT Number: NCT03973619

Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty

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.

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Key information

Conditions

Urethral Stricture Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urethral Diseases Urethral Obstruction Urogenital Diseases Urologic Diseases

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Labial Graft

Procedure

As replacement of the damaged urethral tissue, we used a buccal mucosa graft (labial graft).

Jugal Graft

Procedure

As replacement of the damaged urethral tissue, we used a buccal mucosa graft(inner cheek - jugal graft).

Primary outcomes

  1. Overall Success Rate

    Time frame: 6 months

    Absence of surgical intervention after prior surgery

  2. Labial Group Success Rate

    Time frame: 6 months

    Absence of surgical intervention after prior surgery on patients who received a labial graft.

  3. Jugal Group Success Rate

    Time frame: 6 months

    Absence of surgical intervention after prior surgery on patients who received a inner cheek graft.

  4. Latex Catheter Success Rate

    Time frame: 6 months

    Absence of surgical intervention on patients who used a latex catheter indwelling after prior surgery.

  5. Silicon Catheter Success Rate

    Time frame: 6 months

    Absence of surgical intervention on patients who used a silicon catheter indwelling after prior surgery.

Secondary outcomes

  1. Stricture Etiology

    Time frame: 24 months

    Evaluation of the etiology of the stricture (trauma, other, infectious) on patients included on Labial and Jugal Groups

  2. Stricture Localization

    Time frame: 24 months

    Evaluation of the stricture localization (penile, bulbar/bulbomembranous or combined) on patients included on Labial and Jugal Groups

  3. Stricture Size

    Time frame: 24 months

    Evaluation of the stricture length (cm) on patients included on Labial and Jugal Groups

  4. Demographic Data

    Time frame: 24 months

    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

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Federal University of Rio Grande do Sul

Registry information

Official study title

Urethral Stricture Repair: A Prospective Randomized Analysis Between Jugal or Labial Graft in Buccal Mucosa Urethroplasty

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2019
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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