Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Completed
CT.gov ID
NCT03973619
Collaborator
Federal University of Rio Grande do Sul (Other)
77
2
25.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Labial Graft
  • Procedure: Jugal Graft
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
77 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Urethral Stricture Repair: A Prospective Randomized Analysis Between Jugal or Labial Graft in Buccal Mucosa Urethroplasty
Actual Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
Jul 31, 2018
Actual Study Completion Date :
Nov 27, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Labial

Patients who received a labial graft as replacement of urethral tissue

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

Active Comparator: Jugal

Patients who received a jugal (inner cheek) graft as replacement of urethral tissue

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

Outcome Measures

Primary Outcome Measures

  1. Overall Success Rate [6 months]

    Absence of surgical intervention after prior surgery

  2. Labial Group Success Rate [6 months]

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

  3. Jugal Group Success Rate [6 months]

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

  4. Latex Catheter Success Rate [6 months]

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

  5. Silicon Catheter Success Rate [6 months]

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

Secondary Outcome Measures

  1. Stricture Etiology [24 months]

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

  2. Stricture Localization [24 months]

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

  3. Stricture Size [24 months]

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

  4. Demographic Data [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hospital de Clinicas de Porto Alegre
  • Federal University of Rio Grande do Sul

Investigators

  • Principal Investigator: Brasil S Neto, Phd MD, Hospital de Clinicas de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rafael Carvalho Ipe da Silva, Principal Investigator, MD, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT03973619
Other Study ID Numbers:
  • 170319
First Posted:
Jun 4, 2019
Last Update Posted:
Aug 24, 2020
Last Verified:
Aug 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rafael Carvalho Ipe da Silva, Principal Investigator, MD, Hospital de Clinicas de Porto Alegre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2020