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Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial

BACKGROUND: Harvest of oral mucosa for urethroplasty due to urethral stricture is associated with donor-site-morbidity. We assessed functionality and safety of an authorized tissue-engineered oral mucosa graft (TEOMG) under routine practice in stricture recurrences of any etiology, location, length...

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Autores principales: Ram-Liebig, Gouya, Barbagli, Guido, Heidenreich, Axel, Fahlenkamp, Dirk, Romano, Giuseppe, Rebmann, Udo, Standhaft, Diana, van Ahlen, Hermann, Schakaki, Samer, Balsmeyer, Ulf, Spiegeler, Maria, Knispel, Helmut
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5605371/
https://www.ncbi.nlm.nih.gov/pubmed/28827035
http://dx.doi.org/10.1016/j.ebiom.2017.08.014
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author Ram-Liebig, Gouya
Barbagli, Guido
Heidenreich, Axel
Fahlenkamp, Dirk
Romano, Giuseppe
Rebmann, Udo
Standhaft, Diana
van Ahlen, Hermann
Schakaki, Samer
Balsmeyer, Ulf
Spiegeler, Maria
Knispel, Helmut
author_facet Ram-Liebig, Gouya
Barbagli, Guido
Heidenreich, Axel
Fahlenkamp, Dirk
Romano, Giuseppe
Rebmann, Udo
Standhaft, Diana
van Ahlen, Hermann
Schakaki, Samer
Balsmeyer, Ulf
Spiegeler, Maria
Knispel, Helmut
author_sort Ram-Liebig, Gouya
collection PubMed
description BACKGROUND: Harvest of oral mucosa for urethroplasty due to urethral stricture is associated with donor-site-morbidity. We assessed functionality and safety of an authorized tissue-engineered oral mucosa graft (TEOMG) under routine practice in stricture recurrences of any etiology, location, length and severity (real-world data). METHODS: 99 patients from eight centers with heterogenous urethroplasty experience levels were included in this prospective, non-interventional observational study. Primary and secondary outcomes were success rate (SR) and safety at 12 and 24 months. FINDINGS: All but one patient had ≥ 1, 77.1% (64 of 83) ≥ 2 and 31.3% (26 of 83) ≥ 4 previous surgical treatments. Pre- and postoperative mean ± SD peak flow rate (Qmax) were 8.3 ± 4.7 mL/s (n = 57) and 25.4 ± 14.7 mL/s (n = 51). SR was 67.3% (95% CI 57.6–77.0) at 12 and 58.2% (95% CI 47.7–68.7) at 24 months (conservative Kaplan Meier assessment). SR ranged between 85.7% and 0% in case of high and low surgical experience. Simple proportions of 12-month and 24-month SR for evaluable patients in all centers were 70.8% (46 of 65) and 76.9% (30 of 39). Except for one patient, no oral adverse event was reported. INTERPRETATIONS: TEOMG is safe and efficient in urethroplasty.
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spelling pubmed-56053712017-09-26 Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial Ram-Liebig, Gouya Barbagli, Guido Heidenreich, Axel Fahlenkamp, Dirk Romano, Giuseppe Rebmann, Udo Standhaft, Diana van Ahlen, Hermann Schakaki, Samer Balsmeyer, Ulf Spiegeler, Maria Knispel, Helmut EBioMedicine Research Paper BACKGROUND: Harvest of oral mucosa for urethroplasty due to urethral stricture is associated with donor-site-morbidity. We assessed functionality and safety of an authorized tissue-engineered oral mucosa graft (TEOMG) under routine practice in stricture recurrences of any etiology, location, length and severity (real-world data). METHODS: 99 patients from eight centers with heterogenous urethroplasty experience levels were included in this prospective, non-interventional observational study. Primary and secondary outcomes were success rate (SR) and safety at 12 and 24 months. FINDINGS: All but one patient had ≥ 1, 77.1% (64 of 83) ≥ 2 and 31.3% (26 of 83) ≥ 4 previous surgical treatments. Pre- and postoperative mean ± SD peak flow rate (Qmax) were 8.3 ± 4.7 mL/s (n = 57) and 25.4 ± 14.7 mL/s (n = 51). SR was 67.3% (95% CI 57.6–77.0) at 12 and 58.2% (95% CI 47.7–68.7) at 24 months (conservative Kaplan Meier assessment). SR ranged between 85.7% and 0% in case of high and low surgical experience. Simple proportions of 12-month and 24-month SR for evaluable patients in all centers were 70.8% (46 of 65) and 76.9% (30 of 39). Except for one patient, no oral adverse event was reported. INTERPRETATIONS: TEOMG is safe and efficient in urethroplasty. Elsevier 2017-08-16 /pmc/articles/PMC5605371/ /pubmed/28827035 http://dx.doi.org/10.1016/j.ebiom.2017.08.014 Text en © 2017 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Research Paper
Ram-Liebig, Gouya
Barbagli, Guido
Heidenreich, Axel
Fahlenkamp, Dirk
Romano, Giuseppe
Rebmann, Udo
Standhaft, Diana
van Ahlen, Hermann
Schakaki, Samer
Balsmeyer, Ulf
Spiegeler, Maria
Knispel, Helmut
Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial
title Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial
title_full Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial
title_fullStr Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial
title_full_unstemmed Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial
title_short Results of Use of Tissue-Engineered Autologous Oral Mucosa Graft for Urethral Reconstruction: A Multicenter, Prospective, Observational Trial
title_sort results of use of tissue-engineered autologous oral mucosa graft for urethral reconstruction: a multicenter, prospective, observational trial
topic Research Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5605371/
https://www.ncbi.nlm.nih.gov/pubmed/28827035
http://dx.doi.org/10.1016/j.ebiom.2017.08.014
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