Cargando…

Preoptimisation in patients with acute obstructive colon cancer (PREOCC) – a prospective registration study protocol

BACKGROUND: Postoperative mortality and morbidity rates are high in patients with obstructing colon cancer (OCC). Different treatment options have been evaluated over the years, mainly for left sided OCC. Optimising the preoperative health condition in elective colorectal cancer (CRC) treatment show...

Descripción completa

Detalles Bibliográficos
Autores principales: Boeding, Jeske R. E., Gobardhan, Paul D., Rijken, Arjen M., Seerden, Tom C. J., Verhoef, Cornelis, Schreinemakers, Jennifer M. J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10214621/
https://www.ncbi.nlm.nih.gov/pubmed/37231376
http://dx.doi.org/10.1186/s12876-023-02799-z
_version_ 1785047879607386112
author Boeding, Jeske R. E.
Gobardhan, Paul D.
Rijken, Arjen M.
Seerden, Tom C. J.
Verhoef, Cornelis
Schreinemakers, Jennifer M. J.
author_facet Boeding, Jeske R. E.
Gobardhan, Paul D.
Rijken, Arjen M.
Seerden, Tom C. J.
Verhoef, Cornelis
Schreinemakers, Jennifer M. J.
author_sort Boeding, Jeske R. E.
collection PubMed
description BACKGROUND: Postoperative mortality and morbidity rates are high in patients with obstructing colon cancer (OCC). Different treatment options have been evaluated over the years, mainly for left sided OCC. Optimising the preoperative health condition in elective colorectal cancer (CRC) treatment shows promising results. The aim of this study is to determine whether preoptimisation is feasible in patients with OCC, with a special interest/focus on right-sided OCC, and if, ultimately, optimisation reduces mortality and morbidity (stoma rates, major and minor complications) rates in OCC. METHODS: This is a prospective registration study including all patients presenting with OCC in our hospital. Patients with OCC, treated with curative intent, will be screened for eligibility to receive preoptimisation before surgery. The preoptimisation protocol includes; decompression of the small bowel with a NG-tube for right sided obstruction and SEMS or decompressing ileostomy or colostomy, proximal to the site of obstruction, for left sided colonic obstructions. For the additional work-up, additional nutrition by means of parenteral feeding (for patients who are dependent on a NG tube) or oral/enteral nutrition (in case the obstruction is relieved) is provided. Physiotherapy with attention to both cardio and muscle training prior surgical resection is provided. The primary endpoint is complication-free survival (CFS) at the 90 day period after hospitalisation. Secondary outcomes include pre- and postoperative complications, patient- and tumour characteristics, surgical procedures, total in hospital stay, creation of decompressing and/or permanent ileo- or colostomy and long-term (oncological) outcomes. DISCUSSION: Preoptimisation is expected to improve the preoperative health condition of patients and thereby reduce postoperative complications. TRIAL REGISTRATION: Trial Registry: NL8266 date of registration: 06-jan-2020. STUDY STATUS: Open for inclusion. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12876-023-02799-z.
format Online
Article
Text
id pubmed-10214621
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-102146212023-05-27 Preoptimisation in patients with acute obstructive colon cancer (PREOCC) – a prospective registration study protocol Boeding, Jeske R. E. Gobardhan, Paul D. Rijken, Arjen M. Seerden, Tom C. J. Verhoef, Cornelis Schreinemakers, Jennifer M. J. BMC Gastroenterol Study Protocol BACKGROUND: Postoperative mortality and morbidity rates are high in patients with obstructing colon cancer (OCC). Different treatment options have been evaluated over the years, mainly for left sided OCC. Optimising the preoperative health condition in elective colorectal cancer (CRC) treatment shows promising results. The aim of this study is to determine whether preoptimisation is feasible in patients with OCC, with a special interest/focus on right-sided OCC, and if, ultimately, optimisation reduces mortality and morbidity (stoma rates, major and minor complications) rates in OCC. METHODS: This is a prospective registration study including all patients presenting with OCC in our hospital. Patients with OCC, treated with curative intent, will be screened for eligibility to receive preoptimisation before surgery. The preoptimisation protocol includes; decompression of the small bowel with a NG-tube for right sided obstruction and SEMS or decompressing ileostomy or colostomy, proximal to the site of obstruction, for left sided colonic obstructions. For the additional work-up, additional nutrition by means of parenteral feeding (for patients who are dependent on a NG tube) or oral/enteral nutrition (in case the obstruction is relieved) is provided. Physiotherapy with attention to both cardio and muscle training prior surgical resection is provided. The primary endpoint is complication-free survival (CFS) at the 90 day period after hospitalisation. Secondary outcomes include pre- and postoperative complications, patient- and tumour characteristics, surgical procedures, total in hospital stay, creation of decompressing and/or permanent ileo- or colostomy and long-term (oncological) outcomes. DISCUSSION: Preoptimisation is expected to improve the preoperative health condition of patients and thereby reduce postoperative complications. TRIAL REGISTRATION: Trial Registry: NL8266 date of registration: 06-jan-2020. STUDY STATUS: Open for inclusion. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12876-023-02799-z. BioMed Central 2023-05-25 /pmc/articles/PMC10214621/ /pubmed/37231376 http://dx.doi.org/10.1186/s12876-023-02799-z Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Study Protocol
Boeding, Jeske R. E.
Gobardhan, Paul D.
Rijken, Arjen M.
Seerden, Tom C. J.
Verhoef, Cornelis
Schreinemakers, Jennifer M. J.
Preoptimisation in patients with acute obstructive colon cancer (PREOCC) – a prospective registration study protocol
title Preoptimisation in patients with acute obstructive colon cancer (PREOCC) – a prospective registration study protocol
title_full Preoptimisation in patients with acute obstructive colon cancer (PREOCC) – a prospective registration study protocol
title_fullStr Preoptimisation in patients with acute obstructive colon cancer (PREOCC) – a prospective registration study protocol
title_full_unstemmed Preoptimisation in patients with acute obstructive colon cancer (PREOCC) – a prospective registration study protocol
title_short Preoptimisation in patients with acute obstructive colon cancer (PREOCC) – a prospective registration study protocol
title_sort preoptimisation in patients with acute obstructive colon cancer (preocc) – a prospective registration study protocol
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10214621/
https://www.ncbi.nlm.nih.gov/pubmed/37231376
http://dx.doi.org/10.1186/s12876-023-02799-z
work_keys_str_mv AT boedingjeskere preoptimisationinpatientswithacuteobstructivecoloncancerpreoccaprospectiveregistrationstudyprotocol
AT gobardhanpauld preoptimisationinpatientswithacuteobstructivecoloncancerpreoccaprospectiveregistrationstudyprotocol
AT rijkenarjenm preoptimisationinpatientswithacuteobstructivecoloncancerpreoccaprospectiveregistrationstudyprotocol
AT seerdentomcj preoptimisationinpatientswithacuteobstructivecoloncancerpreoccaprospectiveregistrationstudyprotocol
AT verhoefcornelis preoptimisationinpatientswithacuteobstructivecoloncancerpreoccaprospectiveregistrationstudyprotocol
AT schreinemakersjennifermj preoptimisationinpatientswithacuteobstructivecoloncancerpreoccaprospectiveregistrationstudyprotocol