Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial

Purpose: Trocar site incisional hernia (TSIH) is a common complication of laparoscopic surgery. In the scientific literature there are few descriptions of methods or tools for its prevention. The aim of this report was to assess the effectiveness and safety of a prophylactic measure designed to lowe...

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Autores: Ciscar Bellés, Ana|||0000-0002-5421-0703, Sánchez-Sáez, Emma|||0000-0002-6071-6655, Vila-Tura, Marina|||0000-0002-4985-9970, Ruiz de León, Patricia, Gomez Pallarès, Marta, Troyano Escribano, Daniel, Abadal Prades, Marta, Mans, Esther|||0000-0002-1899-4774, Pereira-Rodríguez, José Antonio|||0000-0003-2457-6955, Badia, Josep M.|||0000-0003-2928-5233
Formato: artículo
Fecha de publicación:2024
País:España
Recursos:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:302358
Acesso em linha:https://ddd.uab.cat/record/302358
https://dx.doi.org/urn:doi:10.1007/s10029-024-03124-7
Access Level:acceso abierto
Palavra-chave:Trocar site incisional hernia
Port site hernia
Incidence
Prophylactic mesh
Randomized clinical trial
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spelling Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trialCiscar Bellés, Ana|||0000-0002-5421-0703Sánchez-Sáez, Emma|||0000-0002-6071-6655Vila-Tura, Marina|||0000-0002-4985-9970Ruiz de León, PatriciaGomez Pallarès, MartaTroyano Escribano, DanielAbadal Prades, MartaMans, Esther|||0000-0002-1899-4774Pereira-Rodríguez, José Antonio|||0000-0003-2457-6955Badia, Josep M.|||0000-0003-2928-5233Trocar site incisional herniaPort site herniaIncidenceProphylactic meshRandomized clinical trialPurpose: Trocar site incisional hernia (TSIH) is a common complication of laparoscopic surgery. In the scientific literature there are few descriptions of methods or tools for its prevention. The aim of this report was to assess the effectiveness and safety of a prophylactic measure designed to lower rates of TSIH. Methods: A multicenter randomized double-blinded clinical trial was performed in high-risk patients (diabetes mellitus and/or age ≥ 70 years and/or BMI ≥ 30 kg/m and/or extended incision for specimen retrieval) who underwent either elective or emergency laparoscopic cholecystectomy. Patients were assigned to prophylactic onlay polypropylene mesh fixation (intervention) or to standard trocar closure (control). The main aim was to analyze the efficacy of the intervention, taking occurrence of TSIH as the primary outcome. Clinical and radiological follow up lasted at least one year after surgery. Secondary endpoints were technique-related complications (surgical site occurrences). Results: One hundred and forty-three patients were randomized and finally 116 were analyzed (64 in the intervention arm and 52 in the control arm). Groups were homogeneous. Mean [SD] age, 65 [18] years; 86 (60.6%) were women. The cumulative TSIH incidence was lower in the intervention group although the differences did not reach statistical significance, assessed either radiologically (16 [25.4%] vs 17 [31.5%], p = 0.538) or clinically (9 [16.1%] vs 9 [20], p = 0.613). No differences in surgical site infection, hematoma or seroma were detected. Mean follow-up was 670 days (range 223-1294). Conclusion: Our results show that, when properly assessed, the overall TSIH incidence is extremely high. Although polypropylene onlay mesh placement is safe, it does not appear to be effective in reducing the TSIH incidence rate. Radiological evaluation may be more accurate. Trial registration: ClinicalTrials.org NCT03495557. Date of registration: April 12, 2018.Universitat Autònoma de Barcelona. Departament de Cirurgia 22024-01-0120242024-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/302358https://dx.doi.org/urn:doi:10.1007/s10029-024-03124-7reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:3023582026-06-06T12:50:31Z
dc.title.none.fl_str_mv Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial
title Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial
spellingShingle Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial
Ciscar Bellés, Ana|||0000-0002-5421-0703
Trocar site incisional hernia
Port site hernia
Incidence
Prophylactic mesh
Randomized clinical trial
title_short Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial
title_full Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial
title_fullStr Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial
title_full_unstemmed Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial
title_sort Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial
dc.creator.none.fl_str_mv Ciscar Bellés, Ana|||0000-0002-5421-0703
Sánchez-Sáez, Emma|||0000-0002-6071-6655
Vila-Tura, Marina|||0000-0002-4985-9970
Ruiz de León, Patricia
Gomez Pallarès, Marta
Troyano Escribano, Daniel
Abadal Prades, Marta
Mans, Esther|||0000-0002-1899-4774
Pereira-Rodríguez, José Antonio|||0000-0003-2457-6955
Badia, Josep M.|||0000-0003-2928-5233
author Ciscar Bellés, Ana|||0000-0002-5421-0703
author_facet Ciscar Bellés, Ana|||0000-0002-5421-0703
Sánchez-Sáez, Emma|||0000-0002-6071-6655
Vila-Tura, Marina|||0000-0002-4985-9970
Ruiz de León, Patricia
Gomez Pallarès, Marta
Troyano Escribano, Daniel
Abadal Prades, Marta
Mans, Esther|||0000-0002-1899-4774
Pereira-Rodríguez, José Antonio|||0000-0003-2457-6955
Badia, Josep M.|||0000-0003-2928-5233
author_role author
author2 Sánchez-Sáez, Emma|||0000-0002-6071-6655
Vila-Tura, Marina|||0000-0002-4985-9970
Ruiz de León, Patricia
Gomez Pallarès, Marta
Troyano Escribano, Daniel
Abadal Prades, Marta
Mans, Esther|||0000-0002-1899-4774
Pereira-Rodríguez, José Antonio|||0000-0003-2457-6955
Badia, Josep M.|||0000-0003-2928-5233
author2_role author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona. Departament de Cirurgia
dc.subject.none.fl_str_mv Trocar site incisional hernia
Port site hernia
Incidence
Prophylactic mesh
Randomized clinical trial
topic Trocar site incisional hernia
Port site hernia
Incidence
Prophylactic mesh
Randomized clinical trial
description Purpose: Trocar site incisional hernia (TSIH) is a common complication of laparoscopic surgery. In the scientific literature there are few descriptions of methods or tools for its prevention. The aim of this report was to assess the effectiveness and safety of a prophylactic measure designed to lower rates of TSIH. Methods: A multicenter randomized double-blinded clinical trial was performed in high-risk patients (diabetes mellitus and/or age ≥ 70 years and/or BMI ≥ 30 kg/m and/or extended incision for specimen retrieval) who underwent either elective or emergency laparoscopic cholecystectomy. Patients were assigned to prophylactic onlay polypropylene mesh fixation (intervention) or to standard trocar closure (control). The main aim was to analyze the efficacy of the intervention, taking occurrence of TSIH as the primary outcome. Clinical and radiological follow up lasted at least one year after surgery. Secondary endpoints were technique-related complications (surgical site occurrences). Results: One hundred and forty-three patients were randomized and finally 116 were analyzed (64 in the intervention arm and 52 in the control arm). Groups were homogeneous. Mean [SD] age, 65 [18] years; 86 (60.6%) were women. The cumulative TSIH incidence was lower in the intervention group although the differences did not reach statistical significance, assessed either radiologically (16 [25.4%] vs 17 [31.5%], p = 0.538) or clinically (9 [16.1%] vs 9 [20], p = 0.613). No differences in surgical site infection, hematoma or seroma were detected. Mean follow-up was 670 days (range 223-1294). Conclusion: Our results show that, when properly assessed, the overall TSIH incidence is extremely high. Although polypropylene onlay mesh placement is safe, it does not appear to be effective in reducing the TSIH incidence rate. Radiological evaluation may be more accurate. Trial registration: ClinicalTrials.org NCT03495557. Date of registration: April 12, 2018.
publishDate 2024
dc.date.none.fl_str_mv 2
2024-01-01
2024
2024-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/302358
https://dx.doi.org/urn:doi:10.1007/s10029-024-03124-7
url https://ddd.uab.cat/record/302358
https://dx.doi.org/urn:doi:10.1007/s10029-024-03124-7
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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