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Minimal Invasive Abdominal Sacral Colpopexy and Abdominal Lateral Suspension: A Prospective, Open-Label, Multicenter, Non-Inferiority Trial

Background: Abdominal minimally invasive surgery has become increasingly prominent for the treatment of prolapse. Abdominal sacral colpopexy (ASC) is the gold standard for the treatment of advanced apical prolapse; however, alternative surgical approaches such as the abdominal lateral suspension (AL...

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Autores principales: Russo, Eleonora, Montt Guevara, Maria Magdalena, Sacinti, Koray Gorkem, Misasi, Giulia, Falcone, Maria, Morganti, Riccardo, Mereu, Liliana, Dalprà, Francesca, Tateo, Saverio, Simoncini, Tommaso
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10147058/
https://www.ncbi.nlm.nih.gov/pubmed/37109262
http://dx.doi.org/10.3390/jcm12082926
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author Russo, Eleonora
Montt Guevara, Maria Magdalena
Sacinti, Koray Gorkem
Misasi, Giulia
Falcone, Maria
Morganti, Riccardo
Mereu, Liliana
Dalprà, Francesca
Tateo, Saverio
Simoncini, Tommaso
author_facet Russo, Eleonora
Montt Guevara, Maria Magdalena
Sacinti, Koray Gorkem
Misasi, Giulia
Falcone, Maria
Morganti, Riccardo
Mereu, Liliana
Dalprà, Francesca
Tateo, Saverio
Simoncini, Tommaso
author_sort Russo, Eleonora
collection PubMed
description Background: Abdominal minimally invasive surgery has become increasingly prominent for the treatment of prolapse. Abdominal sacral colpopexy (ASC) is the gold standard for the treatment of advanced apical prolapse; however, alternative surgical approaches such as the abdominal lateral suspension (ALS) have been developed to improve patient outcomes. This study aims to determine whether ALS improves outcomes compared to ASC in multicompartmental prolapse patients. Methods: A prospective, open-label, multicenter, non-inferiority trial was conducted in 360 patients who underwent ASC or ALS for the treatment of apical prolapse. The primary outcome was anatomical and symptomatic cure of the apical compartment at 1-year follow-up; secondary outcomes included prolapse recurrence, re-operation rate, and post-operative complications. A 300-patient cohort was subdivided into 200-patients who underwent ALS and 100-patients who underwent ASC. The confidence interval method was used to calculate the p-value of non-inferiority. Results: At the 12-months follow-up, the objective cure rate of the apical defect was 92% for ALS and 94% for ASC (recurrence rates were 8% and 6%, respectively, and the p-value for non-inferiority was <0.01). The mMesh complication rates were 1% and 2% for ALS and ASC, respectively. Conclusions: This study demonstrated that the ALS technique is not inferior to the gold standard ASC for the surgical treatment of apical prolapse.
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spelling pubmed-101470582023-04-29 Minimal Invasive Abdominal Sacral Colpopexy and Abdominal Lateral Suspension: A Prospective, Open-Label, Multicenter, Non-Inferiority Trial Russo, Eleonora Montt Guevara, Maria Magdalena Sacinti, Koray Gorkem Misasi, Giulia Falcone, Maria Morganti, Riccardo Mereu, Liliana Dalprà, Francesca Tateo, Saverio Simoncini, Tommaso J Clin Med Article Background: Abdominal minimally invasive surgery has become increasingly prominent for the treatment of prolapse. Abdominal sacral colpopexy (ASC) is the gold standard for the treatment of advanced apical prolapse; however, alternative surgical approaches such as the abdominal lateral suspension (ALS) have been developed to improve patient outcomes. This study aims to determine whether ALS improves outcomes compared to ASC in multicompartmental prolapse patients. Methods: A prospective, open-label, multicenter, non-inferiority trial was conducted in 360 patients who underwent ASC or ALS for the treatment of apical prolapse. The primary outcome was anatomical and symptomatic cure of the apical compartment at 1-year follow-up; secondary outcomes included prolapse recurrence, re-operation rate, and post-operative complications. A 300-patient cohort was subdivided into 200-patients who underwent ALS and 100-patients who underwent ASC. The confidence interval method was used to calculate the p-value of non-inferiority. Results: At the 12-months follow-up, the objective cure rate of the apical defect was 92% for ALS and 94% for ASC (recurrence rates were 8% and 6%, respectively, and the p-value for non-inferiority was <0.01). The mMesh complication rates were 1% and 2% for ALS and ASC, respectively. Conclusions: This study demonstrated that the ALS technique is not inferior to the gold standard ASC for the surgical treatment of apical prolapse. MDPI 2023-04-18 /pmc/articles/PMC10147058/ /pubmed/37109262 http://dx.doi.org/10.3390/jcm12082926 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Russo, Eleonora
Montt Guevara, Maria Magdalena
Sacinti, Koray Gorkem
Misasi, Giulia
Falcone, Maria
Morganti, Riccardo
Mereu, Liliana
Dalprà, Francesca
Tateo, Saverio
Simoncini, Tommaso
Minimal Invasive Abdominal Sacral Colpopexy and Abdominal Lateral Suspension: A Prospective, Open-Label, Multicenter, Non-Inferiority Trial
title Minimal Invasive Abdominal Sacral Colpopexy and Abdominal Lateral Suspension: A Prospective, Open-Label, Multicenter, Non-Inferiority Trial
title_full Minimal Invasive Abdominal Sacral Colpopexy and Abdominal Lateral Suspension: A Prospective, Open-Label, Multicenter, Non-Inferiority Trial
title_fullStr Minimal Invasive Abdominal Sacral Colpopexy and Abdominal Lateral Suspension: A Prospective, Open-Label, Multicenter, Non-Inferiority Trial
title_full_unstemmed Minimal Invasive Abdominal Sacral Colpopexy and Abdominal Lateral Suspension: A Prospective, Open-Label, Multicenter, Non-Inferiority Trial
title_short Minimal Invasive Abdominal Sacral Colpopexy and Abdominal Lateral Suspension: A Prospective, Open-Label, Multicenter, Non-Inferiority Trial
title_sort minimal invasive abdominal sacral colpopexy and abdominal lateral suspension: a prospective, open-label, multicenter, non-inferiority trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10147058/
https://www.ncbi.nlm.nih.gov/pubmed/37109262
http://dx.doi.org/10.3390/jcm12082926
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