Research protocol for the Paraesophageal hernia symptom tool, a prospective multi-center cohort study to identify the need and threshold for surgery and assess the symptom response to surgery

Large hiatus hernias with a significant paraesophageal component (types II-IV) have a range of insidious symptoms. Management of symptomatic hernias includes conservative treatment or surgery. Currently, there is no paraesophageal hernia disease-specific symptom questionnaire. As a result, many clin...

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Autores: Menon, Nainika, Guidozzi, Nadia, Chidambaram, Swathikan, Puri, Aiysha, Sounderajah, Viknesh, Ferri, Lorenzo, Griffiths, Ewen A., Low, Donald E., Maynard, Nick, Mueller, Carmen, Pera Román, Manuel, van Berge Henegouwen, Mark I., Watson, David I., Zaininotto, Giovanni, Hanna, George B., Markar, Sheraz R.
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2023
País:España
Recursos:Universitat Pompeu Fabra
Repositório:Repositorio Digital de la UPF
OAI Identifier:oai:repositori.upf.edu:10230/59416
Acesso em linha:http://hdl.handle.net/10230/59416
http://dx.doi.org/10.1093/dote/doad028
Access Level:Acceso aberto
Palavra-chave:Hernia
Paraesophageal
Surveys and questionnaires
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spelling Research protocol for the Paraesophageal hernia symptom tool, a prospective multi-center cohort study to identify the need and threshold for surgery and assess the symptom response to surgeryMenon, NainikaGuidozzi, NadiaChidambaram, SwathikanPuri, AiyshaSounderajah, VikneshFerri, LorenzoGriffiths, Ewen A.Low, Donald E.Maynard, NickMueller, CarmenPera Román, Manuelvan Berge Henegouwen, Mark I.Watson, David I.Zaininotto, GiovanniHanna, George B.Markar, Sheraz R.HerniaParaesophagealSurveys and questionnairesLarge hiatus hernias with a significant paraesophageal component (types II-IV) have a range of insidious symptoms. Management of symptomatic hernias includes conservative treatment or surgery. Currently, there is no paraesophageal hernia disease-specific symptom questionnaire. As a result, many clinicians rely on the health-related quality of life questionnaires designed for gastro-esophageal reflux disease (GORD) to assess patients with hiatal hernias pre- and postoperatively. In view of this, a paraesophageal hernia symptom tool (POST) was designed. This POST questionnaire now requires validation and assessment of clinical utility. Twenty-one international sites will recruit patients with paraesophageal hernias to complete a series of questionnaires over a five-year period. There will be two cohorts of patients-patients with paraesophageal hernias undergoing surgery and patients managed conservatively. Patients are required to complete a validated GORD-HRQL, POST questionnaire, and satisfaction questionnaire preoperatively. Surgical cohorts will also complete questionnaires postoperatively at 4-6 weeks, 6 months, 12 months, and then annually for a total of 5 years. Conservatively managed patients will repeat questionnaires at 1 year. The first set of results will be released after 1 year with complete data published after a 5-year follow-up. The main results of the study will be patient's acceptance of the POST tool, clinical utility of the tool, assessment of the threshold for surgery, and patient symptom response to surgery. The study will validate the POST questionnaire and identify the relevance of the questionnaire in routine management of paraesophageal hernias.Oxford University Press202420242023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/59416http://dx.doi.org/10.1093/dote/doad028reponame:Repositorio Digital de la UPFinstname:Universitat Pompeu FabraInglésDis Esophagus. 2023 Sep 30;36(10):doad028© The Author(s) 2023. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.http://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repositori.upf.edu:10230/594162026-06-12T07:21:37Z
dc.title.none.fl_str_mv Research protocol for the Paraesophageal hernia symptom tool, a prospective multi-center cohort study to identify the need and threshold for surgery and assess the symptom response to surgery
title Research protocol for the Paraesophageal hernia symptom tool, a prospective multi-center cohort study to identify the need and threshold for surgery and assess the symptom response to surgery
spellingShingle Research protocol for the Paraesophageal hernia symptom tool, a prospective multi-center cohort study to identify the need and threshold for surgery and assess the symptom response to surgery
Menon, Nainika
Hernia
Paraesophageal
Surveys and questionnaires
title_short Research protocol for the Paraesophageal hernia symptom tool, a prospective multi-center cohort study to identify the need and threshold for surgery and assess the symptom response to surgery
title_full Research protocol for the Paraesophageal hernia symptom tool, a prospective multi-center cohort study to identify the need and threshold for surgery and assess the symptom response to surgery
title_fullStr Research protocol for the Paraesophageal hernia symptom tool, a prospective multi-center cohort study to identify the need and threshold for surgery and assess the symptom response to surgery
title_full_unstemmed Research protocol for the Paraesophageal hernia symptom tool, a prospective multi-center cohort study to identify the need and threshold for surgery and assess the symptom response to surgery
title_sort Research protocol for the Paraesophageal hernia symptom tool, a prospective multi-center cohort study to identify the need and threshold for surgery and assess the symptom response to surgery
dc.creator.none.fl_str_mv Menon, Nainika
Guidozzi, Nadia
Chidambaram, Swathikan
Puri, Aiysha
Sounderajah, Viknesh
Ferri, Lorenzo
Griffiths, Ewen A.
Low, Donald E.
Maynard, Nick
Mueller, Carmen
Pera Román, Manuel
van Berge Henegouwen, Mark I.
Watson, David I.
Zaininotto, Giovanni
Hanna, George B.
Markar, Sheraz R.
author Menon, Nainika
author_facet Menon, Nainika
Guidozzi, Nadia
Chidambaram, Swathikan
Puri, Aiysha
Sounderajah, Viknesh
Ferri, Lorenzo
Griffiths, Ewen A.
Low, Donald E.
Maynard, Nick
Mueller, Carmen
Pera Román, Manuel
van Berge Henegouwen, Mark I.
Watson, David I.
Zaininotto, Giovanni
Hanna, George B.
Markar, Sheraz R.
author_role author
author2 Guidozzi, Nadia
Chidambaram, Swathikan
Puri, Aiysha
Sounderajah, Viknesh
Ferri, Lorenzo
Griffiths, Ewen A.
Low, Donald E.
Maynard, Nick
Mueller, Carmen
Pera Román, Manuel
van Berge Henegouwen, Mark I.
Watson, David I.
Zaininotto, Giovanni
Hanna, George B.
Markar, Sheraz R.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Hernia
Paraesophageal
Surveys and questionnaires
topic Hernia
Paraesophageal
Surveys and questionnaires
description Large hiatus hernias with a significant paraesophageal component (types II-IV) have a range of insidious symptoms. Management of symptomatic hernias includes conservative treatment or surgery. Currently, there is no paraesophageal hernia disease-specific symptom questionnaire. As a result, many clinicians rely on the health-related quality of life questionnaires designed for gastro-esophageal reflux disease (GORD) to assess patients with hiatal hernias pre- and postoperatively. In view of this, a paraesophageal hernia symptom tool (POST) was designed. This POST questionnaire now requires validation and assessment of clinical utility. Twenty-one international sites will recruit patients with paraesophageal hernias to complete a series of questionnaires over a five-year period. There will be two cohorts of patients-patients with paraesophageal hernias undergoing surgery and patients managed conservatively. Patients are required to complete a validated GORD-HRQL, POST questionnaire, and satisfaction questionnaire preoperatively. Surgical cohorts will also complete questionnaires postoperatively at 4-6 weeks, 6 months, 12 months, and then annually for a total of 5 years. Conservatively managed patients will repeat questionnaires at 1 year. The first set of results will be released after 1 year with complete data published after a 5-year follow-up. The main results of the study will be patient's acceptance of the POST tool, clinical utility of the tool, assessment of the threshold for surgery, and patient symptom response to surgery. The study will validate the POST questionnaire and identify the relevance of the questionnaire in routine management of paraesophageal hernias.
publishDate 2023
dc.date.none.fl_str_mv 2023
2024
2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/59416
http://dx.doi.org/10.1093/dote/doad028
url http://hdl.handle.net/10230/59416
http://dx.doi.org/10.1093/dote/doad028
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Dis Esophagus. 2023 Sep 30;36(10):doad028
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Oxford University Press
publisher.none.fl_str_mv Oxford University Press
dc.source.none.fl_str_mv reponame:Repositorio Digital de la UPF
instname:Universitat Pompeu Fabra
instname_str Universitat Pompeu Fabra
reponame_str Repositorio Digital de la UPF
collection Repositorio Digital de la UPF
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,223283

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