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

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  • dc.contributor.author Menon, Nainika
  • dc.contributor.author Guidozzi, Nadia
  • dc.contributor.author Chidambaram, Swathikan
  • dc.contributor.author Puri, Aiysha
  • dc.contributor.author Sounderajah, Viknesh
  • dc.contributor.author Ferri, Lorenzo
  • dc.contributor.author Griffiths, Ewen A.
  • dc.contributor.author Low, Donald E.
  • dc.contributor.author Maynard, Nick
  • dc.contributor.author Mueller, Carmen
  • dc.contributor.author Pera Roman, Manuel Ramón
  • dc.contributor.author van Berge Henegouwen, Mark I.
  • dc.contributor.author Watson, David I.
  • dc.contributor.author Zaininotto, Giovanni
  • dc.contributor.author Hanna, George B.
  • dc.contributor.author Markar, Sheraz R.
  • dc.date.accessioned 2024-03-15T07:07:10Z
  • dc.date.available 2024-03-15T07:07:10Z
  • dc.date.issued 2023
  • dc.description.abstract 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.
  • dc.format.mimetype application/pdf
  • dc.identifier.citation Menon N, Guidozzi N, Chidambaram S, Puri A, Sounderajah V, Ferri L, Griffiths EA, Low D, Maynard N, Mueller C, Pera M, van Berge Henegouwen MI, Watson DI, Zaininotto G, Hanna GB, Markar SR. 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. Dis Esophagus. 2023 Sep 30;36(10):doad028. DOI: 10.1093/dote/doad028
  • dc.identifier.doi http://dx.doi.org/10.1093/dote/doad028
  • dc.identifier.issn 1120-8694
  • dc.identifier.uri http://hdl.handle.net/10230/59416
  • dc.language.iso eng
  • dc.publisher Oxford University Press
  • dc.relation.ispartof Dis Esophagus. 2023 Sep 30;36(10):doad028
  • dc.rights © 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.
  • dc.rights.accessRights info:eu-repo/semantics/openAccess
  • dc.rights.uri http://creativecommons.org/licenses/by/4.0/
  • dc.subject.keyword Hernia
  • dc.subject.keyword Paraesophageal
  • dc.subject.keyword Surveys and questionnaires
  • dc.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
  • dc.type info:eu-repo/semantics/article
  • dc.type.version info:eu-repo/semantics/publishedVersion

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