Midline incisional hernia prophylaxis using synthetic mesh in an emergency or urgent gastrointestinal tract surgery: a protocol for multicentre randomised clinical trial

Amarit Tansawet; Pawin Numthavaj; Preeda Sumritpradit; Suphakarn Techapongsatorn; Gareth McKay; John Attia; Ammarin Thakkinstian

doi:10.1136/bmjopen-2020-045541

Midline incisional hernia prophylaxis using synthetic mesh in an emergency or urgent gastrointestinal tract surgery: a protocol for multicentre randomised clinical trial

Amarit Tansawet, Pawin Numthavaj, Preeda Sumritpradit, Suphakarn Techapongsatorn, Gareth McKay, John Attia, Ammarin Thakkinstian

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Abstract

INTRODUCTION: Between 5% and 30% of abdominal incisions eventually result in incisional hernias (IHs) that can lead to severe complications and impaired quality of life. Unfortunately, IH repair is often unsuccessful; therefore, hernia prophylaxis is an important issue. The efficacy of mesh augmentation has been proven for hernia prophylaxis in high-risk patients, but no randomised clinical trial has evaluated prophylactic mesh placement in emergency/urgent gastrointestinal operations.

METHODS AND ANALYSIS: A multicentre, prospective randomised, open and patient-assessor blinded endpoint design will be conducted. A total of 470 patients will be enrolled and randomly allocated to retrorectus mesh augmentation with lightweight polypropylene mesh or primary suture closure. The primary outcome is IH occurrence within 24 months of follow-up, while other clinical outcomes are secondary endpoints. A cost-effectiveness analysis will be conducted from the societal and provider perspectives.

ETHICS AND DISSEMINATION: Ethics approval was obtained from Ramathibodi Hospital (MURA2020/1478) and Vajira Hospital (COA164/2563). The protocol is on the process of submission to the local ethics committee of the other study sites. Results will be submitted for publication in a peer-reviewed journal.

TRIAL REGISTRATION NUMBER: TCTR20200924002.

Original language	English
Pages (from-to)	e045541
Journal	BMJ Open
Volume	11
Issue number	9
DOIs	https://doi.org/10.1136/bmjopen-2020-045541
Publication status	Published - 03 Sept 2021

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Midline incisional hernia prophylaxis using synthetic mesh in an emergency or urgent gastrointestinal tract surgery: a protocol for multicentre randomised clinical trial
Copyright 2021 the authors. This is an open access Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits use, distribution and reproduction for non-commercial purposes, provided the author and source are cited.
Final published version, 756 KBLicence: CC BY-NC

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title = "Midline incisional hernia prophylaxis using synthetic mesh in an emergency or urgent gastrointestinal tract surgery: a protocol for multicentre randomised clinical trial",

abstract = "INTRODUCTION: Between 5% and 30% of abdominal incisions eventually result in incisional hernias (IHs) that can lead to severe complications and impaired quality of life. Unfortunately, IH repair is often unsuccessful; therefore, hernia prophylaxis is an important issue. The efficacy of mesh augmentation has been proven for hernia prophylaxis in high-risk patients, but no randomised clinical trial has evaluated prophylactic mesh placement in emergency/urgent gastrointestinal operations.METHODS AND ANALYSIS: A multicentre, prospective randomised, open and patient-assessor blinded endpoint design will be conducted. A total of 470 patients will be enrolled and randomly allocated to retrorectus mesh augmentation with lightweight polypropylene mesh or primary suture closure. The primary outcome is IH occurrence within 24 months of follow-up, while other clinical outcomes are secondary endpoints. A cost-effectiveness analysis will be conducted from the societal and provider perspectives.ETHICS AND DISSEMINATION: Ethics approval was obtained from Ramathibodi Hospital (MURA2020/1478) and Vajira Hospital (COA164/2563). The protocol is on the process of submission to the local ethics committee of the other study sites. Results will be submitted for publication in a peer-reviewed journal.TRIAL REGISTRATION NUMBER: TCTR20200924002.",

author = "Amarit Tansawet and Pawin Numthavaj and Preeda Sumritpradit and Suphakarn Techapongsatorn and Gareth McKay and John Attia and Ammarin Thakkinstian",

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T1 - Midline incisional hernia prophylaxis using synthetic mesh in an emergency or urgent gastrointestinal tract surgery: a protocol for multicentre randomised clinical trial

AU - Tansawet, Amarit

AU - Numthavaj, Pawin

AU - Sumritpradit, Preeda

AU - Techapongsatorn, Suphakarn

AU - McKay, Gareth

AU - Attia, John

AU - Thakkinstian, Ammarin

PY - 2021/9/3

Y1 - 2021/9/3

N2 - INTRODUCTION: Between 5% and 30% of abdominal incisions eventually result in incisional hernias (IHs) that can lead to severe complications and impaired quality of life. Unfortunately, IH repair is often unsuccessful; therefore, hernia prophylaxis is an important issue. The efficacy of mesh augmentation has been proven for hernia prophylaxis in high-risk patients, but no randomised clinical trial has evaluated prophylactic mesh placement in emergency/urgent gastrointestinal operations.METHODS AND ANALYSIS: A multicentre, prospective randomised, open and patient-assessor blinded endpoint design will be conducted. A total of 470 patients will be enrolled and randomly allocated to retrorectus mesh augmentation with lightweight polypropylene mesh or primary suture closure. The primary outcome is IH occurrence within 24 months of follow-up, while other clinical outcomes are secondary endpoints. A cost-effectiveness analysis will be conducted from the societal and provider perspectives.ETHICS AND DISSEMINATION: Ethics approval was obtained from Ramathibodi Hospital (MURA2020/1478) and Vajira Hospital (COA164/2563). The protocol is on the process of submission to the local ethics committee of the other study sites. Results will be submitted for publication in a peer-reviewed journal.TRIAL REGISTRATION NUMBER: TCTR20200924002.

AB - INTRODUCTION: Between 5% and 30% of abdominal incisions eventually result in incisional hernias (IHs) that can lead to severe complications and impaired quality of life. Unfortunately, IH repair is often unsuccessful; therefore, hernia prophylaxis is an important issue. The efficacy of mesh augmentation has been proven for hernia prophylaxis in high-risk patients, but no randomised clinical trial has evaluated prophylactic mesh placement in emergency/urgent gastrointestinal operations.METHODS AND ANALYSIS: A multicentre, prospective randomised, open and patient-assessor blinded endpoint design will be conducted. A total of 470 patients will be enrolled and randomly allocated to retrorectus mesh augmentation with lightweight polypropylene mesh or primary suture closure. The primary outcome is IH occurrence within 24 months of follow-up, while other clinical outcomes are secondary endpoints. A cost-effectiveness analysis will be conducted from the societal and provider perspectives.ETHICS AND DISSEMINATION: Ethics approval was obtained from Ramathibodi Hospital (MURA2020/1478) and Vajira Hospital (COA164/2563). The protocol is on the process of submission to the local ethics committee of the other study sites. Results will be submitted for publication in a peer-reviewed journal.TRIAL REGISTRATION NUMBER: TCTR20200924002.

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M3 - Article

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SP - e045541

JO - BMJ Open

JF - BMJ Open

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Midline incisional hernia prophylaxis using synthetic mesh in an emergency or urgent gastrointestinal tract surgery: a protocol for multicentre randomised clinical trial

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