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Hughes abdominal closure versus standard mass closure to reduce incisional hernias following surgery for colorectal cancer: the HART RCT

Susan O’Connell Orcid Logo, Saiful Islam Orcid Logo, Berni Sewell Orcid Logo, Angela Farr Orcid Logo, Laura Knight Orcid Logo, Nadim Bashir Orcid Logo, Rhiannon Harries Orcid Logo, Sian Jones, Andrew Cleves Orcid Logo, Greg Fegan Orcid Logo, Alan Watkins Orcid Logo, Jared Torkington Orcid Logo

Health Technology Assessment, Volume: 26, Issue: 34, Pages: 1 - 100

Swansea University Authors: Saiful Islam Orcid Logo, Berni Sewell Orcid Logo, Angela Farr Orcid Logo, Alan Watkins Orcid Logo

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DOI (Published version): 10.3310/cmwc8368

Abstract

BackgroundIncisional hernias can cause chronic pain and complications and affect quality of life. Surgical repair requires health-care resources and has a significant associated failure rate. A prospective, multicentre, single-blinded randomised controlled trial was conducted to investigate the clin...

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Published in: Health Technology Assessment
ISSN: 1366-5278 2046-4924
Published: National Institute for Health and Care Research (NIHR) 2022
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URI: https://cronfa.swan.ac.uk/Record/cronfa60827
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fullrecord <?xml version="1.0"?><rfc1807><datestamp>2022-11-03T15:10:17.3150240</datestamp><bib-version>v2</bib-version><id>60827</id><entry>2022-08-16</entry><title>Hughes abdominal closure versus standard mass closure to reduce incisional hernias following surgery for colorectal cancer: the HART RCT</title><swanseaauthors><author><sid>4157d27b800a8357873bdfc9c71bd596</sid><ORCID>0000-0003-3182-8487</ORCID><firstname>Saiful</firstname><surname>Islam</surname><name>Saiful Islam</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>f6a4af2cfa4275d2a8ebba292fa14421</sid><ORCID>0000-0001-5471-922X</ORCID><firstname>Berni</firstname><surname>Sewell</surname><name>Berni Sewell</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>ab00dbaa888f32b41b07ef223d0e2987</sid><ORCID>0000-0002-2087-9310</ORCID><firstname>Angela</firstname><surname>Farr</surname><name>Angela Farr</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>81fc05c9333d9df41b041157437bcc2f</sid><ORCID>0000-0003-3804-1943</ORCID><firstname>Alan</firstname><surname>Watkins</surname><name>Alan Watkins</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2022-08-16</date><deptcode>HDAT</deptcode><abstract>BackgroundIncisional hernias can cause chronic pain and complications and affect quality of life. Surgical repair requires health-care resources and has a significant associated failure rate. A prospective, multicentre, single-blinded randomised controlled trial was conducted to investigate the clinical effectiveness and cost-effectiveness of the Hughes abdominal closure method compared with standard mass closure following surgery for colorectal cancer. The study randomised, in a 1&#x2009;:&#x2009;1 ratio, 802 adult patients (aged &#x2265;&#x2009;18 years) undergoing surgical resection for colorectal cancer from 28 surgical departments in UK centres.InterventionHughes abdominal closure or standard mass closure.Main outcome measuresThe primary outcome was the incidence of incisional hernias at 1 year, as assessed by clinical examination. Within-trial cost-effectiveness and cost&#x2013;utility analyses over 1 year were conducted from an NHS and a social care perspective. A key secondary outcome was quality of life, and other outcomes included the incidence of incisional hernias as detected by computed tomography scanning.ResultsThe incidence of incisional hernia at 1-year clinical examination was 50 (14.8%) in the Hughes abdominal closure arm compared with 57 (17.1%) in the standard mass closure arm (odds ratio 0.84, 95% confidence interval 0.55 to 1.27; p&#x2009;=&#x2009;0.4). In year 2, the incidence of incisional hernia was 78 (28.7%) in the Hughes abdominal closure arm compared with 84 (31.8%) in the standard mass closure arm (odds ratio 0.86, 95% confidence interval 0.59 to 1.25; p&#x2009;=&#x2009;0.43). Computed tomography scanning identified a total of 301 incisional hernias across both arms, compared with 100 identified by clinical examination at the 1-year follow-up. Computed tomography scanning missed 16 incisional hernias that were picked up by clinical examination. Hughes abdominal closure was found to be less cost-effective than standard mass closure. The mean incremental cost for patients undergoing Hughes abdominal closure was &#xA3;616.45 (95% confidence interval &#x2013;&#xA3;699.56 to &#xA3;1932.47; p&#x2009;=&#x2009;0.3580). Quality of life did not differ significantly between the study arms at any time point.LimitationsAs this was a pragmatic trial, the control arm allowed surgeon discretion in the approach to standard mass closure, introducing variability in the techniques and equipment used. Intraoperative randomisation may result in a loss of equipoise for some surgeons. Follow-up was limited to 2 years, which may not have been enough time to see a difference in the primary outcome.ConclusionsHughes abdominal closure did not significantly reduce the incidence of incisional hernias detected by clinical examination and was less cost-effective at 1 year than standard mass closure in colorectal cancer patients. Computed tomography scanning may be more effective at identifying incisional hernias than clinical examination, but the clinical benefit of this needs further research.Future workAn extended follow-up using routinely collected NHS data sets aims to report on incisional hernia rates at 2&#x2013;5 years post surgery to investigate any potential mortality benefit of the closure methods. Furthermore, the proportion of incisional hernias identified by a computed tomography scan (at 1 and 2 years post surgery), but not during clinical examination (occult hernias), proceeding to surgical repair within 3&#x2013;5 years after the initial operation will be explored.Trial registrationThis trial is registered as ISRCTN25616490.</abstract><type>Journal Article</type><journal>Health Technology Assessment</journal><volume>26</volume><journalNumber>34</journalNumber><paginationStart>1</paginationStart><paginationEnd>100</paginationEnd><publisher>National Institute for Health and Care Research (NIHR)</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>1366-5278</issnPrint><issnElectronic>2046-4924</issnElectronic><keywords/><publishedDay>1</publishedDay><publishedMonth>8</publishedMonth><publishedYear>2022</publishedYear><publishedDate>2022-08-01</publishedDate><doi>10.3310/cmwc8368</doi><url/><notes/><college>COLLEGE NANME</college><department>Health Data Science</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HDAT</DepartmentCode><institution>Swansea University</institution><apcterm>Not Required</apcterm><funders>This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme</funders><projectreference/><lastEdited>2022-11-03T15:10:17.3150240</lastEdited><Created>2022-08-16T13:25:31.7811976</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">Swansea University Medical School - Medicine</level></path><authors><author><firstname>Susan</firstname><surname>O&#x2019;Connell</surname><orcid>0000-0002-5887-2771</orcid><order>1</order></author><author><firstname>Saiful</firstname><surname>Islam</surname><orcid>0000-0003-3182-8487</orcid><order>2</order></author><author><firstname>Berni</firstname><surname>Sewell</surname><orcid>0000-0001-5471-922X</orcid><order>3</order></author><author><firstname>Angela</firstname><surname>Farr</surname><orcid>0000-0002-2087-9310</orcid><order>4</order></author><author><firstname>Laura</firstname><surname>Knight</surname><orcid>0000-0003-2726-8026</orcid><order>5</order></author><author><firstname>Nadim</firstname><surname>Bashir</surname><orcid>0000-0003-0501-1342</orcid><order>6</order></author><author><firstname>Rhiannon</firstname><surname>Harries</surname><orcid>0000-0001-7095-3673</orcid><order>7</order></author><author><firstname>Sian</firstname><surname>Jones</surname><order>8</order></author><author><firstname>Andrew</firstname><surname>Cleves</surname><orcid>0000-0003-0431-3138</orcid><order>9</order></author><author><firstname>Greg</firstname><surname>Fegan</surname><orcid>0000-0002-2663-2765</orcid><order>10</order></author><author><firstname>Alan</firstname><surname>Watkins</surname><orcid>0000-0003-3804-1943</orcid><order>11</order></author><author><firstname>Jared</firstname><surname>Torkington</surname><orcid>0000-0002-3218-0574</orcid><order>12</order></author></authors><documents><document><filename>60827__25038__a07a78ca4367493a8fb46ee7182b9c45.pdf</filename><originalFilename>60827_VoR.pdf</originalFilename><uploaded>2022-08-30T11:38:37.8213511</uploaded><type>Output</type><contentLength>1534917</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>Released under the terms of a Creative Commons Licence</documentNotes><copyrightCorrect>true</copyrightCorrect><language>eng</language><licence>http://creativecommons.org/licenses/by/4.0/</licence></document></documents><OutputDurs/></rfc1807>
spelling 2022-11-03T15:10:17.3150240 v2 60827 2022-08-16 Hughes abdominal closure versus standard mass closure to reduce incisional hernias following surgery for colorectal cancer: the HART RCT 4157d27b800a8357873bdfc9c71bd596 0000-0003-3182-8487 Saiful Islam Saiful Islam true false f6a4af2cfa4275d2a8ebba292fa14421 0000-0001-5471-922X Berni Sewell Berni Sewell true false ab00dbaa888f32b41b07ef223d0e2987 0000-0002-2087-9310 Angela Farr Angela Farr true false 81fc05c9333d9df41b041157437bcc2f 0000-0003-3804-1943 Alan Watkins Alan Watkins true false 2022-08-16 HDAT BackgroundIncisional hernias can cause chronic pain and complications and affect quality of life. Surgical repair requires health-care resources and has a significant associated failure rate. A prospective, multicentre, single-blinded randomised controlled trial was conducted to investigate the clinical effectiveness and cost-effectiveness of the Hughes abdominal closure method compared with standard mass closure following surgery for colorectal cancer. The study randomised, in a 1 : 1 ratio, 802 adult patients (aged ≥ 18 years) undergoing surgical resection for colorectal cancer from 28 surgical departments in UK centres.InterventionHughes abdominal closure or standard mass closure.Main outcome measuresThe primary outcome was the incidence of incisional hernias at 1 year, as assessed by clinical examination. Within-trial cost-effectiveness and cost–utility analyses over 1 year were conducted from an NHS and a social care perspective. A key secondary outcome was quality of life, and other outcomes included the incidence of incisional hernias as detected by computed tomography scanning.ResultsThe incidence of incisional hernia at 1-year clinical examination was 50 (14.8%) in the Hughes abdominal closure arm compared with 57 (17.1%) in the standard mass closure arm (odds ratio 0.84, 95% confidence interval 0.55 to 1.27; p = 0.4). In year 2, the incidence of incisional hernia was 78 (28.7%) in the Hughes abdominal closure arm compared with 84 (31.8%) in the standard mass closure arm (odds ratio 0.86, 95% confidence interval 0.59 to 1.25; p = 0.43). Computed tomography scanning identified a total of 301 incisional hernias across both arms, compared with 100 identified by clinical examination at the 1-year follow-up. Computed tomography scanning missed 16 incisional hernias that were picked up by clinical examination. Hughes abdominal closure was found to be less cost-effective than standard mass closure. The mean incremental cost for patients undergoing Hughes abdominal closure was £616.45 (95% confidence interval –£699.56 to £1932.47; p = 0.3580). Quality of life did not differ significantly between the study arms at any time point.LimitationsAs this was a pragmatic trial, the control arm allowed surgeon discretion in the approach to standard mass closure, introducing variability in the techniques and equipment used. Intraoperative randomisation may result in a loss of equipoise for some surgeons. Follow-up was limited to 2 years, which may not have been enough time to see a difference in the primary outcome.ConclusionsHughes abdominal closure did not significantly reduce the incidence of incisional hernias detected by clinical examination and was less cost-effective at 1 year than standard mass closure in colorectal cancer patients. Computed tomography scanning may be more effective at identifying incisional hernias than clinical examination, but the clinical benefit of this needs further research.Future workAn extended follow-up using routinely collected NHS data sets aims to report on incisional hernia rates at 2–5 years post surgery to investigate any potential mortality benefit of the closure methods. Furthermore, the proportion of incisional hernias identified by a computed tomography scan (at 1 and 2 years post surgery), but not during clinical examination (occult hernias), proceeding to surgical repair within 3–5 years after the initial operation will be explored.Trial registrationThis trial is registered as ISRCTN25616490. Journal Article Health Technology Assessment 26 34 1 100 National Institute for Health and Care Research (NIHR) 1366-5278 2046-4924 1 8 2022 2022-08-01 10.3310/cmwc8368 COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University Not Required This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme 2022-11-03T15:10:17.3150240 2022-08-16T13:25:31.7811976 Faculty of Medicine, Health and Life Sciences Swansea University Medical School - Medicine Susan O’Connell 0000-0002-5887-2771 1 Saiful Islam 0000-0003-3182-8487 2 Berni Sewell 0000-0001-5471-922X 3 Angela Farr 0000-0002-2087-9310 4 Laura Knight 0000-0003-2726-8026 5 Nadim Bashir 0000-0003-0501-1342 6 Rhiannon Harries 0000-0001-7095-3673 7 Sian Jones 8 Andrew Cleves 0000-0003-0431-3138 9 Greg Fegan 0000-0002-2663-2765 10 Alan Watkins 0000-0003-3804-1943 11 Jared Torkington 0000-0002-3218-0574 12 60827__25038__a07a78ca4367493a8fb46ee7182b9c45.pdf 60827_VoR.pdf 2022-08-30T11:38:37.8213511 Output 1534917 application/pdf Version of Record true Released under the terms of a Creative Commons Licence true eng http://creativecommons.org/licenses/by/4.0/
title Hughes abdominal closure versus standard mass closure to reduce incisional hernias following surgery for colorectal cancer: the HART RCT
spellingShingle Hughes abdominal closure versus standard mass closure to reduce incisional hernias following surgery for colorectal cancer: the HART RCT
Saiful Islam
Berni Sewell
Angela Farr
Alan Watkins
title_short Hughes abdominal closure versus standard mass closure to reduce incisional hernias following surgery for colorectal cancer: the HART RCT
title_full Hughes abdominal closure versus standard mass closure to reduce incisional hernias following surgery for colorectal cancer: the HART RCT
title_fullStr Hughes abdominal closure versus standard mass closure to reduce incisional hernias following surgery for colorectal cancer: the HART RCT
title_full_unstemmed Hughes abdominal closure versus standard mass closure to reduce incisional hernias following surgery for colorectal cancer: the HART RCT
title_sort Hughes abdominal closure versus standard mass closure to reduce incisional hernias following surgery for colorectal cancer: the HART RCT
author_id_str_mv 4157d27b800a8357873bdfc9c71bd596
f6a4af2cfa4275d2a8ebba292fa14421
ab00dbaa888f32b41b07ef223d0e2987
81fc05c9333d9df41b041157437bcc2f
author_id_fullname_str_mv 4157d27b800a8357873bdfc9c71bd596_***_Saiful Islam
f6a4af2cfa4275d2a8ebba292fa14421_***_Berni Sewell
ab00dbaa888f32b41b07ef223d0e2987_***_Angela Farr
81fc05c9333d9df41b041157437bcc2f_***_Alan Watkins
author Saiful Islam
Berni Sewell
Angela Farr
Alan Watkins
author2 Susan O’Connell
Saiful Islam
Berni Sewell
Angela Farr
Laura Knight
Nadim Bashir
Rhiannon Harries
Sian Jones
Andrew Cleves
Greg Fegan
Alan Watkins
Jared Torkington
format Journal article
container_title Health Technology Assessment
container_volume 26
container_issue 34
container_start_page 1
publishDate 2022
institution Swansea University
issn 1366-5278
2046-4924
doi_str_mv 10.3310/cmwc8368
publisher National Institute for Health and Care Research (NIHR)
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str Swansea University Medical School - Medicine{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}Swansea University Medical School - Medicine
document_store_str 1
active_str 0
description BackgroundIncisional hernias can cause chronic pain and complications and affect quality of life. Surgical repair requires health-care resources and has a significant associated failure rate. A prospective, multicentre, single-blinded randomised controlled trial was conducted to investigate the clinical effectiveness and cost-effectiveness of the Hughes abdominal closure method compared with standard mass closure following surgery for colorectal cancer. The study randomised, in a 1 : 1 ratio, 802 adult patients (aged ≥ 18 years) undergoing surgical resection for colorectal cancer from 28 surgical departments in UK centres.InterventionHughes abdominal closure or standard mass closure.Main outcome measuresThe primary outcome was the incidence of incisional hernias at 1 year, as assessed by clinical examination. Within-trial cost-effectiveness and cost–utility analyses over 1 year were conducted from an NHS and a social care perspective. A key secondary outcome was quality of life, and other outcomes included the incidence of incisional hernias as detected by computed tomography scanning.ResultsThe incidence of incisional hernia at 1-year clinical examination was 50 (14.8%) in the Hughes abdominal closure arm compared with 57 (17.1%) in the standard mass closure arm (odds ratio 0.84, 95% confidence interval 0.55 to 1.27; p = 0.4). In year 2, the incidence of incisional hernia was 78 (28.7%) in the Hughes abdominal closure arm compared with 84 (31.8%) in the standard mass closure arm (odds ratio 0.86, 95% confidence interval 0.59 to 1.25; p = 0.43). Computed tomography scanning identified a total of 301 incisional hernias across both arms, compared with 100 identified by clinical examination at the 1-year follow-up. Computed tomography scanning missed 16 incisional hernias that were picked up by clinical examination. Hughes abdominal closure was found to be less cost-effective than standard mass closure. The mean incremental cost for patients undergoing Hughes abdominal closure was £616.45 (95% confidence interval –£699.56 to £1932.47; p = 0.3580). Quality of life did not differ significantly between the study arms at any time point.LimitationsAs this was a pragmatic trial, the control arm allowed surgeon discretion in the approach to standard mass closure, introducing variability in the techniques and equipment used. Intraoperative randomisation may result in a loss of equipoise for some surgeons. Follow-up was limited to 2 years, which may not have been enough time to see a difference in the primary outcome.ConclusionsHughes abdominal closure did not significantly reduce the incidence of incisional hernias detected by clinical examination and was less cost-effective at 1 year than standard mass closure in colorectal cancer patients. Computed tomography scanning may be more effective at identifying incisional hernias than clinical examination, but the clinical benefit of this needs further research.Future workAn extended follow-up using routinely collected NHS data sets aims to report on incisional hernia rates at 2–5 years post surgery to investigate any potential mortality benefit of the closure methods. Furthermore, the proportion of incisional hernias identified by a computed tomography scan (at 1 and 2 years post surgery), but not during clinical examination (occult hernias), proceeding to surgical repair within 3–5 years after the initial operation will be explored.Trial registrationThis trial is registered as ISRCTN25616490.
published_date 2022-08-01T04:19:16Z
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