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PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study

INTRODUCTION: Diverticulitis is among the most common abdominal disorders. The best treatment strategy for this complicated disease as well as for recurrent stages is still under debate. Moreover, little knowledge exists regarding the effect of different therapeutic strategies on the health-related...

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Autores principales: Sohn, Maximilian, Agha, Ayman, Iesalnieks, Igors, Bremer, Susanne, Trum, Stefanie, Di Cerbo, Francesca, Nerlich, Andreas, Lotz, Natalie, Klieser, Eckhard, Hochrein, Alfred, Schredl, Philipp, Kalcheva, Dariya, Emmanuel, Klaus, Presl, Jaroslav
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7202696/
https://www.ncbi.nlm.nih.gov/pubmed/32209628
http://dx.doi.org/10.1136/bmjopen-2019-034385
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author Sohn, Maximilian
Agha, Ayman
Iesalnieks, Igors
Bremer, Susanne
Trum, Stefanie
Di Cerbo, Francesca
Nerlich, Andreas
Lotz, Natalie
Klieser, Eckhard
Hochrein, Alfred
Schredl, Philipp
Kalcheva, Dariya
Emmanuel, Klaus
Presl, Jaroslav
author_facet Sohn, Maximilian
Agha, Ayman
Iesalnieks, Igors
Bremer, Susanne
Trum, Stefanie
Di Cerbo, Francesca
Nerlich, Andreas
Lotz, Natalie
Klieser, Eckhard
Hochrein, Alfred
Schredl, Philipp
Kalcheva, Dariya
Emmanuel, Klaus
Presl, Jaroslav
author_sort Sohn, Maximilian
collection PubMed
description INTRODUCTION: Diverticulitis is among the most common abdominal disorders. The best treatment strategy for this complicated disease as well as for recurrent stages is still under debate. Moreover, little knowledge exists regarding the effect of different therapeutic strategies on the health-related quality of life (HrQoL). Therefore, the PREDIC-DIV (PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease) study aims to assess predictors of a change in HrQoL in patients after elective sigmoidectomy for diverticular disease. METHODS AND ANALYSIS: A prospective multicentre transnational observational study was started in November 2017. Patients undergoing elective sigmoid resection for diverticular disease were included. Primary outcome includes HrQoL 6 months postoperatively, staged by the Gastrointestinal Quality of Life Index (GIQLI). Secondary outcomes include HrQoL 6 months after sigmoidectomy, assessed using the Short Form 36 Questionnaire and a custom-made Visual Analogue Scale-based inventory; HrQoL after 12 and 24 months; postoperative morbidity; mortality; influence of surgical technique (conventional laparoscopic multiport operation vs robotic approach); histological grading of inflammation and morphological characteristics of the bowel wall in the resected specimen; postoperative functional changes (faecal incontinence, faecal urge, completeness of emptying, urinary incontinence, sexual function); disease-specific healthcare costs; and changes in economic productivity, measured by the iMTA Productivity Cost Questionnaire. The total follow-up will be 2 years. ETHICS AND DISSEMINATION: The protocol was approved by the medical ethical committee of the Bavarian Medical Council (report identification number: 2017-177). The study was conducted in accordance with the Declaration of Helsinki. The findings of this study will be submitted to a peer-reviewed journal (BMJ Open, Annals of Surgery, British Journal of Surgery, Diseases of the Colon and the Rectum). Abstracts will be submitted to relevant national and international conferences. TRIAL REGISTRATION NUMBER: The study is registered with the ClinicalTrials.gov register as NCT03527706; Pre-results.
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spelling pubmed-72026962020-05-13 PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study Sohn, Maximilian Agha, Ayman Iesalnieks, Igors Bremer, Susanne Trum, Stefanie Di Cerbo, Francesca Nerlich, Andreas Lotz, Natalie Klieser, Eckhard Hochrein, Alfred Schredl, Philipp Kalcheva, Dariya Emmanuel, Klaus Presl, Jaroslav BMJ Open Surgery INTRODUCTION: Diverticulitis is among the most common abdominal disorders. The best treatment strategy for this complicated disease as well as for recurrent stages is still under debate. Moreover, little knowledge exists regarding the effect of different therapeutic strategies on the health-related quality of life (HrQoL). Therefore, the PREDIC-DIV (PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease) study aims to assess predictors of a change in HrQoL in patients after elective sigmoidectomy for diverticular disease. METHODS AND ANALYSIS: A prospective multicentre transnational observational study was started in November 2017. Patients undergoing elective sigmoid resection for diverticular disease were included. Primary outcome includes HrQoL 6 months postoperatively, staged by the Gastrointestinal Quality of Life Index (GIQLI). Secondary outcomes include HrQoL 6 months after sigmoidectomy, assessed using the Short Form 36 Questionnaire and a custom-made Visual Analogue Scale-based inventory; HrQoL after 12 and 24 months; postoperative morbidity; mortality; influence of surgical technique (conventional laparoscopic multiport operation vs robotic approach); histological grading of inflammation and morphological characteristics of the bowel wall in the resected specimen; postoperative functional changes (faecal incontinence, faecal urge, completeness of emptying, urinary incontinence, sexual function); disease-specific healthcare costs; and changes in economic productivity, measured by the iMTA Productivity Cost Questionnaire. The total follow-up will be 2 years. ETHICS AND DISSEMINATION: The protocol was approved by the medical ethical committee of the Bavarian Medical Council (report identification number: 2017-177). The study was conducted in accordance with the Declaration of Helsinki. The findings of this study will be submitted to a peer-reviewed journal (BMJ Open, Annals of Surgery, British Journal of Surgery, Diseases of the Colon and the Rectum). Abstracts will be submitted to relevant national and international conferences. TRIAL REGISTRATION NUMBER: The study is registered with the ClinicalTrials.gov register as NCT03527706; Pre-results. BMJ Publishing Group 2020-03-23 /pmc/articles/PMC7202696/ /pubmed/32209628 http://dx.doi.org/10.1136/bmjopen-2019-034385 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Surgery
Sohn, Maximilian
Agha, Ayman
Iesalnieks, Igors
Bremer, Susanne
Trum, Stefanie
Di Cerbo, Francesca
Nerlich, Andreas
Lotz, Natalie
Klieser, Eckhard
Hochrein, Alfred
Schredl, Philipp
Kalcheva, Dariya
Emmanuel, Klaus
Presl, Jaroslav
PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study
title PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study
title_full PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study
title_fullStr PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study
title_full_unstemmed PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study
title_short PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study
title_sort predictors for health-related quality of life after elective sigmoidectomy for diverticular disease: the predic-div study protocol of a prospective multicentric transnational observational study
topic Surgery
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7202696/
https://www.ncbi.nlm.nih.gov/pubmed/32209628
http://dx.doi.org/10.1136/bmjopen-2019-034385
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