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

Jeske R.E. Boeding; Paul D. Gobardhan; Arjen M. Rijken; Tom C.J. Seerden; Cornelis Verhoef; Jennifer M.J. Schreinemakers

doi:10.1186/s12876-023-02799-z

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

Jeske R.E. Boeding^*, Paul D. Gobardhan, Arjen M. Rijken, Tom C.J. Seerden, Cornelis Verhoef, Jennifer M.J. Schreinemakers

^*Corresponding author for this work

Surgery

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

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.

Original language	English
Article number	186
Pages (from-to)	186
Number of pages	1
Journal	BMC Gastroenterology
Volume	23
Issue number	1
DOIs	https://doi.org/10.1186/s12876-023-02799-z
Publication status	Published - Dec 2023

Bibliographical note

Funding:
A donation received from Wetenschapsfonds, Amphia Ziekenhuis for the
preparations of this study. With the use of this funding this registration study
could be started as for additional research to set up a multicentre implementation study.

Publisher Copyright:
© 2023. The Author(s).

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This output contributes to the following UN Sustainable Development Goals (SDGs)

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Preoptimisation in patients with acute obstructive colon cancer (PREOCC) – a prospective registration study protocolFinal published version, 2.24 MBLicence: CC BY

Cite this

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title = "Preoptimisation in patients with acute obstructive colon cancer (PREOCC) - a prospective registration study protocol",

abstract = "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.",

author = "Boeding, {Jeske R.E.} and Gobardhan, {Paul D.} and Rijken, {Arjen M.} and Seerden, {Tom C.J.} and Cornelis Verhoef and Schreinemakers, {Jennifer M.J.}",

note = "Funding: A donation received from Wetenschapsfonds, Amphia Ziekenhuis for the preparations of this study. With the use of this funding this registration study could be started as for additional research to set up a multicentre implementation study. Publisher Copyright: {\textcopyright} 2023. The Author(s).",

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doi = "10.1186/s12876-023-02799-z",

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T1 - Preoptimisation in patients with acute obstructive colon cancer (PREOCC) - a prospective registration study protocol

AU - Boeding, Jeske R.E.

AU - Gobardhan, Paul D.

AU - Rijken, Arjen M.

AU - Seerden, Tom C.J.

AU - Verhoef, Cornelis

AU - Schreinemakers, Jennifer M.J.

N1 - Funding: A donation received from Wetenschapsfonds, Amphia Ziekenhuis for the preparations of this study. With the use of this funding this registration study could be started as for additional research to set up a multicentre implementation study. Publisher Copyright: © 2023. The Author(s).

PY - 2023/12

Y1 - 2023/12

N2 - 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.

AB - 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.

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SN - 1471-230X

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JO - BMC Gastroenterology

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ER -

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

Abstract

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