Protocol for the UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study)

Hana Tabusa; Jane M Blazeby; Natalie Blencowe; Mark Callaway; Ian R Daniels; Amanda Gunning; William Hollingworth; Angus G McNair; Charlotte Murkin; Thomas D Pinkney; Chris A Rogers; Neil J Smart; Barnaby C Reeves

doi:10.1111/codi.15621

Protocol for the UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study)

Hana Tabusa, Jane M Blazeby, Natalie Blencowe, Mark Callaway, Ian R Daniels, Amanda Gunning, William Hollingworth, Angus G McNair, Charlotte Murkin, Thomas D Pinkney, Chris A Rogers, Neil J Smart, Barnaby C Reeves

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Abstract

Background: Abdominal surgery sometimes necessitates creating a stoma, which can cause future complications including parastomal hernia (PSH), an incisional hernia, adjacent and related to the stoma. PSH affects approximately 40% of patients within two years of stoma formation. Complications of PSH reduce patients’ quality of life and can be severe, e.g. bowel obstruction. PSH
are difficult to manage and can recur after surgical repair. Therefore, it is very important to prevent a PSH. Surgeons create stomas in different ways and both patient and surgical factors are believed to influence the development of PSH. The CIPHER study has been designed to investigate the influence of different surgical techniques on PSH development.

Method: The CIPHER study aims to recruit 4000 patients undergoing elective or expedited surgery with the intention to form an ileostomy or colostomy, irrespective of the primary indication for the planned surgery. For each patient, surgeons describe their methods of trephine formation, mesh reinforcement of the stoma trephine, use of the stoma as specimen extraction site and closure of wounds. The primary outcome is incident PSH during follow-up defined as symptoms of PSH (custom-designed questionnaire) and anatomical PSH, ascertained by independent reading of usual care CT scans. Secondary outcomes include; surgical site infection, Comprehensive Complication Index, quality of life (EQ-5D-5L and SF-12), PSH repair and use of NHS resources.

Discussion: The CIPHER study is the first to investigate detailed surgical methods of stoma formation, in a large, representative cohort of patients with range of primary indications, both cancer and noncancer.

Original language	English
Pages (from-to)	1900-1908
Number of pages	9
Journal	Colorectal Disease
Volume	23
Issue number	7
Early online date	9 Mar 2021
DOIs	https://doi.org/10.1111/codi.15621
Publication status	Published - Jul 2021

Bibliographical note

Funding Information:
The CIPHER study is funded by the NIHR Health Technology Assessment (HTA) Programme (grant ref. 14/166/01). The development work for the questionnaire and methods for understanding surgical techniques were funded by the MRC Hub for Trials Methodology Research in Bristol (ConDuCT‐II Hub). The study sponsor is the Royal Devon and Exeter NHS Foundation Trust and the study is managed by the Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol. The CIPHER study is overseen by an independent study steering committee. The study has been designed with input from public and patient groups who fed back comments on the study protocol and reviewed patient‐facing documentation. The study is supported by Colostomy UK and the Ileostomy Association. The study is conducted in compliance with General Data Protection Regulations and Good Clinical Practice.

Funding Information:
The sponsor is the Royal Devon and Exeter NHS Foundation Trust. This study is funded by the NIHR Health Technology Assessment Programme (ref. 14/166/01). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. JMB is an NIHR Senior Investigator. JMB, NB, AMcN, BR and CR are supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at the University Hospitals Bristol and Weston National Health Service (NHS) Foundation Trust and the University of Bristol. The views expressed are those of the authors and not necessarily those of the UK NHS, NIHR or Department of Health. JMB is an NIHR Senior Investigator. NSB is a Medical Research Council Clinician Scientist.

Funding Information:
The sponsor is the Royal Devon and Exeter NHS Foundation Trust. This study is funded by the NIHR Health Technology Assessment Programme (ref. 14/166/01). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. JMB is an NIHR Senior Investigator. JMB, NB, AMcN, BR and CR are supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at the University Hospitals Bristol and Weston National Health Service (NHS) Foundation Trust and the University of Bristol. The views expressed are those of the authors and not necessarily those of the UK NHS, NIHR or Department of Health. JMB is an NIHR Senior Investigator. NSB is a Medical Research Council Clinician Scientist.

Publisher Copyright:
© 2021 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland

Research Groups and Themes

HEHP@Bristol

Keywords

cohort study
stoma
parastomal hernia

UN SDGs

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

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Tabusa, H., Blazeby, J. M., Blencowe, N., Callaway, M., Daniels, I. R., Gunning, A., Hollingworth, W., McNair, A. G., Murkin, C., Pinkney, T. D., Rogers, C. A., Smart, N. J., & Reeves, B. C. (2021). Protocol for the UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study). Colorectal Disease, 23(7), 1900-1908. https://doi.org/10.1111/codi.15621

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abstract = "Background: Abdominal surgery sometimes necessitates creating a stoma, which can cause future complications including parastomal hernia (PSH), an incisional hernia, adjacent and related to the stoma. PSH affects approximately 40% of patients within two years of stoma formation. Complications of PSH reduce patients{\textquoteright} quality of life and can be severe, e.g. bowel obstruction. PSH are difficult to manage and can recur after surgical repair. Therefore, it is very important to prevent a PSH. Surgeons create stomas in different ways and both patient and surgical factors are believed to influence the development of PSH. The CIPHER study has been designed to investigate the influence of different surgical techniques on PSH development.Method: The CIPHER study aims to recruit 4000 patients undergoing elective or expedited surgery with the intention to form an ileostomy or colostomy, irrespective of the primary indication for the planned surgery. For each patient, surgeons describe their methods of trephine formation, mesh reinforcement of the stoma trephine, use of the stoma as specimen extraction site and closure of wounds. The primary outcome is incident PSH during follow-up defined as symptoms of PSH (custom-designed questionnaire) and anatomical PSH, ascertained by independent reading of usual care CT scans. Secondary outcomes include; surgical site infection, Comprehensive Complication Index, quality of life (EQ-5D-5L and SF-12), PSH repair and use of NHS resources. Discussion: The CIPHER study is the first to investigate detailed surgical methods of stoma formation, in a large, representative cohort of patients with range of primary indications, both cancer and noncancer.",

keywords = "cohort study, stoma, parastomal hernia",

author = "Hana Tabusa and Blazeby, {Jane M} and Natalie Blencowe and Mark Callaway and Daniels, {Ian R} and Amanda Gunning and William Hollingworth and McNair, {Angus G} and Charlotte Murkin and Pinkney, {Thomas D} and Rogers, {Chris A} and Smart, {Neil J} and Reeves, {Barnaby C}",

note = "Funding Information: The CIPHER study is funded by the NIHR Health Technology Assessment (HTA) Programme (grant ref. 14/166/01). The development work for the questionnaire and methods for understanding surgical techniques were funded by the MRC Hub for Trials Methodology Research in Bristol (ConDuCT‐II Hub). The study sponsor is the Royal Devon and Exeter NHS Foundation Trust and the study is managed by the Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol. The CIPHER study is overseen by an independent study steering committee. The study has been designed with input from public and patient groups who fed back comments on the study protocol and reviewed patient‐facing documentation. The study is supported by Colostomy UK and the Ileostomy Association. The study is conducted in compliance with General Data Protection Regulations and Good Clinical Practice. Funding Information: The sponsor is the Royal Devon and Exeter NHS Foundation Trust. This study is funded by the NIHR Health Technology Assessment Programme (ref. 14/166/01). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. JMB is an NIHR Senior Investigator. JMB, NB, AMcN, BR and CR are supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at the University Hospitals Bristol and Weston National Health Service (NHS) Foundation Trust and the University of Bristol. The views expressed are those of the authors and not necessarily those of the UK NHS, NIHR or Department of Health. JMB is an NIHR Senior Investigator. NSB is a Medical Research Council Clinician Scientist. Funding Information: The sponsor is the Royal Devon and Exeter NHS Foundation Trust. This study is funded by the NIHR Health Technology Assessment Programme (ref. 14/166/01). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. JMB is an NIHR Senior Investigator. JMB, NB, AMcN, BR and CR are supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at the University Hospitals Bristol and Weston National Health Service (NHS) Foundation Trust and the University of Bristol. The views expressed are those of the authors and not necessarily those of the UK NHS, NIHR or Department of Health. JMB is an NIHR Senior Investigator. NSB is a Medical Research Council Clinician Scientist. Publisher Copyright: {\textcopyright} 2021 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland",

year = "2021",

month = jul,

doi = "10.1111/codi.15621",

language = "English",

volume = "23",

pages = "1900--1908",

journal = "Colorectal Disease",

issn = "1462-8910",

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TY - JOUR

T1 - Protocol for the UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study)

AU - Tabusa, Hana

AU - Blazeby, Jane M

AU - Blencowe, Natalie

AU - Callaway, Mark

AU - Daniels, Ian R

AU - Gunning, Amanda

AU - Hollingworth, William

AU - McNair, Angus G

AU - Murkin, Charlotte

AU - Pinkney, Thomas D

AU - Rogers, Chris A

AU - Smart, Neil J

AU - Reeves, Barnaby C

N1 - Funding Information: The CIPHER study is funded by the NIHR Health Technology Assessment (HTA) Programme (grant ref. 14/166/01). The development work for the questionnaire and methods for understanding surgical techniques were funded by the MRC Hub for Trials Methodology Research in Bristol (ConDuCT‐II Hub). The study sponsor is the Royal Devon and Exeter NHS Foundation Trust and the study is managed by the Clinical Trials and Evaluation Unit, Bristol Trials Centre, Bristol. The CIPHER study is overseen by an independent study steering committee. The study has been designed with input from public and patient groups who fed back comments on the study protocol and reviewed patient‐facing documentation. The study is supported by Colostomy UK and the Ileostomy Association. The study is conducted in compliance with General Data Protection Regulations and Good Clinical Practice. Funding Information: The sponsor is the Royal Devon and Exeter NHS Foundation Trust. This study is funded by the NIHR Health Technology Assessment Programme (ref. 14/166/01). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. JMB is an NIHR Senior Investigator. JMB, NB, AMcN, BR and CR are supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at the University Hospitals Bristol and Weston National Health Service (NHS) Foundation Trust and the University of Bristol. The views expressed are those of the authors and not necessarily those of the UK NHS, NIHR or Department of Health. JMB is an NIHR Senior Investigator. NSB is a Medical Research Council Clinician Scientist. Funding Information: The sponsor is the Royal Devon and Exeter NHS Foundation Trust. This study is funded by the NIHR Health Technology Assessment Programme (ref. 14/166/01). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. JMB is an NIHR Senior Investigator. JMB, NB, AMcN, BR and CR are supported by the National Institute for Health Research (NIHR) Biomedical Research Centre at the University Hospitals Bristol and Weston National Health Service (NHS) Foundation Trust and the University of Bristol. The views expressed are those of the authors and not necessarily those of the UK NHS, NIHR or Department of Health. JMB is an NIHR Senior Investigator. NSB is a Medical Research Council Clinician Scientist. Publisher Copyright: © 2021 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland

PY - 2021/7

Y1 - 2021/7

N2 - Background: Abdominal surgery sometimes necessitates creating a stoma, which can cause future complications including parastomal hernia (PSH), an incisional hernia, adjacent and related to the stoma. PSH affects approximately 40% of patients within two years of stoma formation. Complications of PSH reduce patients’ quality of life and can be severe, e.g. bowel obstruction. PSH are difficult to manage and can recur after surgical repair. Therefore, it is very important to prevent a PSH. Surgeons create stomas in different ways and both patient and surgical factors are believed to influence the development of PSH. The CIPHER study has been designed to investigate the influence of different surgical techniques on PSH development.Method: The CIPHER study aims to recruit 4000 patients undergoing elective or expedited surgery with the intention to form an ileostomy or colostomy, irrespective of the primary indication for the planned surgery. For each patient, surgeons describe their methods of trephine formation, mesh reinforcement of the stoma trephine, use of the stoma as specimen extraction site and closure of wounds. The primary outcome is incident PSH during follow-up defined as symptoms of PSH (custom-designed questionnaire) and anatomical PSH, ascertained by independent reading of usual care CT scans. Secondary outcomes include; surgical site infection, Comprehensive Complication Index, quality of life (EQ-5D-5L and SF-12), PSH repair and use of NHS resources. Discussion: The CIPHER study is the first to investigate detailed surgical methods of stoma formation, in a large, representative cohort of patients with range of primary indications, both cancer and noncancer.

AB - Background: Abdominal surgery sometimes necessitates creating a stoma, which can cause future complications including parastomal hernia (PSH), an incisional hernia, adjacent and related to the stoma. PSH affects approximately 40% of patients within two years of stoma formation. Complications of PSH reduce patients’ quality of life and can be severe, e.g. bowel obstruction. PSH are difficult to manage and can recur after surgical repair. Therefore, it is very important to prevent a PSH. Surgeons create stomas in different ways and both patient and surgical factors are believed to influence the development of PSH. The CIPHER study has been designed to investigate the influence of different surgical techniques on PSH development.Method: The CIPHER study aims to recruit 4000 patients undergoing elective or expedited surgery with the intention to form an ileostomy or colostomy, irrespective of the primary indication for the planned surgery. For each patient, surgeons describe their methods of trephine formation, mesh reinforcement of the stoma trephine, use of the stoma as specimen extraction site and closure of wounds. The primary outcome is incident PSH during follow-up defined as symptoms of PSH (custom-designed questionnaire) and anatomical PSH, ascertained by independent reading of usual care CT scans. Secondary outcomes include; surgical site infection, Comprehensive Complication Index, quality of life (EQ-5D-5L and SF-12), PSH repair and use of NHS resources. Discussion: The CIPHER study is the first to investigate detailed surgical methods of stoma formation, in a large, representative cohort of patients with range of primary indications, both cancer and noncancer.

KW - cohort study

KW - stoma

KW - parastomal hernia

U2 - 10.1111/codi.15621

DO - 10.1111/codi.15621

M3 - Article (Academic Journal)

C2 - 33686656

SN - 1462-8910

VL - 23

SP - 1900

EP - 1908

JO - Colorectal Disease

JF - Colorectal Disease

IS - 7

ER -

Protocol for the UK cohort study to investigate the prevention of parastomal hernia (the CIPHER study)

Abstract

Bibliographical note

Research Groups and Themes

Keywords

UN SDGs

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