Urethral Stricture: A Comparison Between Jugal or Labial Graft Urethroplasty

NCT ID: NCT03973619

Last Updated: 2020-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2018-11-27

Brief Summary

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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

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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.

Conditions

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Urethral Stricture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Labial

Patients who received a labial graft as replacement of urethral tissue

Group Type ACTIVE_COMPARATOR

Labial Graft

Intervention Type PROCEDURE

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

Jugal

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

Group Type ACTIVE_COMPARATOR

Jugal Graft

Intervention Type PROCEDURE

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

Interventions

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Labial Graft

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

Intervention Type PROCEDURE

Jugal Graft

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Rafael Carvalho Ipe da Silva

Principal Investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brasil S Neto, Phd MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clinicas de Porto Alegre

References

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Barbagli G, Palminteri E, Guazzoni G, Montorsi F, Turini D, Lazzeri M. Bulbar urethroplasty using buccal mucosa grafts placed on the ventral, dorsal or lateral surface of the urethra: are results affected by the surgical technique? J Urol. 2005 Sep;174(3):955-7; discussion 957-8. doi: 10.1097/01.ju.0000169422.46721.d7.

Reference Type BACKGROUND
PMID: 16094007 (View on PubMed)

Bracka A. A versatile two-stage hypospadias repair. Br J Plast Surg. 1995 Sep;48(6):345-52. doi: 10.1016/s0007-1226(95)90023-3.

Reference Type BACKGROUND
PMID: 7551506 (View on PubMed)

Morey AF, McAninch JW. When and how to use buccal mucosal grafts in adult bulbar urethroplasty. Urology. 1996 Aug;48(2):194-8. doi: 10.1016/S0090-4295(96)00154-9.

Reference Type BACKGROUND
PMID: 8753728 (View on PubMed)

Palminteri E, Lumen N, Berdondini E, Di Pierro GB, Cucchiarale G, Tenti G, De Nunzio C. Two-sided dorsal plus ventral oral graft bulbar urethroplasty: long-term results and predictive factors. Urology. 2015 Apr;85(4):942-7. doi: 10.1016/j.urology.2015.01.013.

Reference Type BACKGROUND
PMID: 25817122 (View on PubMed)

Pansadoro V, Emiliozzi P, Gaffi M, Scarpone P, DePaula F, Pizzo M. Buccal mucosa urethroplasty in the treatment of bulbar urethral strictures. Urology. 2003 May;61(5):1008-10. doi: 10.1016/s0090-4295(02)02585-2.

Reference Type BACKGROUND
PMID: 12736025 (View on PubMed)

Sharma AK, Chandrashekar R, Keshavamurthy R, Nelvigi GG, Kamath AJ, Sharma S, Venkatesh GK. Lingual versus buccal mucosa graft urethroplasty for anterior urethral stricture: a prospective comparative analysis. Int J Urol. 2013 Dec;20(12):1199-203. doi: 10.1111/iju.12158. Epub 2013 Apr 21.

Reference Type BACKGROUND
PMID: 23601029 (View on PubMed)

Barbagli G, Palminteri E, Lazzeri M, Guazzoni G, Turini D. Long-term outcome of urethroplasty after failed urethrotomy versus primary repair. J Urol. 2001 Jun;165(6 Pt 1):1918-9. doi: 10.1097/00005392-200106000-00018.

Reference Type BACKGROUND
PMID: 11371881 (View on PubMed)

Martinez-Pineiro JA, Martinez-Pineiro L, Tabernero A. [Substitution urethroplasties with free graft buccal mucosa]. Arch Esp Urol. 1998 Sep;51(7):645-59. Spanish.

Reference Type BACKGROUND
PMID: 9807890 (View on PubMed)

Barbagli G, Pellegrini G, Corradini F, Montorsi F, Sansalone S, Butnaru D, Lazzeri M. One-stage Penile Urethroplasty Using Oral Mucosal Graft and Glue. Eur Urol. 2016 Dec;70(6):1069-1075. doi: 10.1016/j.eururo.2016.04.025. Epub 2016 May 6.

Reference Type BACKGROUND
PMID: 27160949 (View on PubMed)

Aldaqadossi H, El Gamal S, El-Nadey M, El Gamal O, Radwan M, Gaber M. Dorsal onlay (Barbagli technique) versus dorsal inlay (Asopa technique) buccal mucosal graft urethroplasty for anterior urethral stricture: a prospective randomized study. Int J Urol. 2014 Feb;21(2):185-8. doi: 10.1111/iju.12235. Epub 2013 Aug 12.

Reference Type BACKGROUND
PMID: 23931150 (View on PubMed)

Fichtner J, Filipas D, Fisch M, Hohenfellner R, Thuroff JW. Long-term outcome of ventral buccal mucosa onlay graft urethroplasty for urethral stricture repair. Urology. 2004 Oct;64(4):648-50. doi: 10.1016/j.urology.2004.05.011.

Reference Type BACKGROUND
PMID: 15491691 (View on PubMed)

Asopa HS, Garg M, Singhal GG, Singh L, Asopa J, Nischal A. Dorsal free graft urethroplasty for urethral stricture by ventral sagittal urethrotomy approach. Urology. 2001 Nov;58(5):657-9. doi: 10.1016/s0090-4295(01)01377-2.

Reference Type BACKGROUND
PMID: 11711331 (View on PubMed)

Akyuz M, Gunes M, Koca O, Sertkaya Z, Kanberoglu H, Karaman MI. Evaluation of intraoral complications of buccal mucosa graft in augmentation urethroplasty. Turk J Urol. 2014 Sep;40(3):156-60. doi: 10.5152/tud.2014.46343.

Reference Type BACKGROUND
PMID: 26328170 (View on PubMed)

Barbagli G, Vallasciani S, Romano G, Fabbri F, Guazzoni G, Lazzeri M. Morbidity of oral mucosa graft harvesting from a single cheek. Eur Urol. 2010 Jul;58(1):33-41. doi: 10.1016/j.eururo.2010.01.012. Epub 2010 Jan 19.

Reference Type BACKGROUND
PMID: 20106587 (View on PubMed)

Elbaz J, Le Long E, Dugardin F, Sibert L, Peron JM. [Buccal mucosal graft for the treatment of urethral stricture]. Ann Chir Plast Esthet. 2012 Dec;57(6):626-9. doi: 10.1016/j.anplas.2010.09.008. Epub 2010 Oct 14. French.

Reference Type BACKGROUND
PMID: 20950921 (View on PubMed)

Other Identifiers

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170319

Identifier Type: -

Identifier Source: org_study_id

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