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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...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2017
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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. |
format | Online Article Text |
id | pubmed-5605371 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
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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