The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019)
Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-t...
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creator | Gardenbroek, Tjibbe J Pinkney, Thomas D Sahami, Saloomeh Morton, Dion G Buskens, Christianne J Ponsioen, Cyriel Y Tanis, Pieter J Löwenberg, Mark van den Brink, Gijs R Broeders, Ivo Amj Pullens, Paul Hjm Seerden, Tom Boom, Maarten J Mallant-Hent, Rosalie C Pierik, Robert Egjm Vecht, Juda Sosef, Meindert N van Nunen, Annick B van Wagensveld, Bart A Stokkers, Pieter Cf Gerhards, Michael F Jansen, Jeroen M Acherman, Yair Depla, Annekatrien Ctm Mannaerts, Guido Hh West, Rachel Iqbal, Tariq Pathmakanthan, Shrikanth Howard, Rebecca Magill, Laura Singh, Baljit Htun Oo, Ye Negpodiev, Dmitri Dijkgraaf, Marcel Gw Ram D'Haens, Geert Bemelman, Willem A |
description | Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-term efficacy of appendectomy to maintain remission in patients with UC, and to establish the acceptability and cost-effectiveness of the intervention compared to standard treatment.
These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score |
doi_str_mv | 10.1186/s12893-015-0017-1 |
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These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission. Patients will then be randomised 1:1 to a control group (maintenance 5-ASA treatment, no appendectomy) or elective laparoscopic appendectomy plus maintenance treatment. The primary outcome measure is the one year cumulative UC relapse rate - defined both clinically and endoscopically as a total Mayo-score ≥5 with endoscopic subscore of 2 or 3. Secondary outcomes that will be assessed include the number of relapses per patient at 12 months, the time to first relapse, health related quality of life and treatment costs, and number of colectomies in each arm.
The ACCURE and ACCURE-UK trials will provide evidence on the role and acceptability of appendectomy in the treatment of ulcerative colitis and the effects of appendectomy on the disease course.
NTR2883 ; ISRCTN56523019.</description><identifier>ISSN: 1471-2482</identifier><identifier>EISSN: 1471-2482</identifier><identifier>DOI: 10.1186/s12893-015-0017-1</identifier><identifier>PMID: 25887789</identifier><language>eng</language><publisher>England: BioMed Central</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Appendectomy - methods ; Clinical Protocols ; Colitis, Ulcerative - surgery ; Female ; Humans ; Laparoscopy ; Male ; Middle Aged ; Pilot Projects ; Prospective Studies ; Quality of Life ; Recurrence ; Study Protocol ; Treatment Outcome</subject><ispartof>BMC surgery, 2015-03, Vol.15 (1), p.30-30, Article 30</ispartof><rights>Gardenbroek et al.; licensee BioMed Central. 2015</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c399t-c67c8df3ceab3f4f38f5ef25c243e8fafa7f703c8bf949ed6a829e1164ceb5993</citedby><cites>FETCH-LOGICAL-c399t-c67c8df3ceab3f4f38f5ef25c243e8fafa7f703c8bf949ed6a829e1164ceb5993</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4393565/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4393565/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,27901,27902,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25887789$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gardenbroek, Tjibbe J</creatorcontrib><creatorcontrib>Pinkney, Thomas D</creatorcontrib><creatorcontrib>Sahami, Saloomeh</creatorcontrib><creatorcontrib>Morton, Dion G</creatorcontrib><creatorcontrib>Buskens, Christianne J</creatorcontrib><creatorcontrib>Ponsioen, Cyriel Y</creatorcontrib><creatorcontrib>Tanis, Pieter J</creatorcontrib><creatorcontrib>Löwenberg, Mark</creatorcontrib><creatorcontrib>van den Brink, Gijs R</creatorcontrib><creatorcontrib>Broeders, Ivo Amj</creatorcontrib><creatorcontrib>Pullens, Paul Hjm</creatorcontrib><creatorcontrib>Seerden, Tom</creatorcontrib><creatorcontrib>Boom, Maarten J</creatorcontrib><creatorcontrib>Mallant-Hent, Rosalie C</creatorcontrib><creatorcontrib>Pierik, Robert Egjm</creatorcontrib><creatorcontrib>Vecht, Juda</creatorcontrib><creatorcontrib>Sosef, Meindert N</creatorcontrib><creatorcontrib>van Nunen, Annick B</creatorcontrib><creatorcontrib>van Wagensveld, Bart A</creatorcontrib><creatorcontrib>Stokkers, Pieter Cf</creatorcontrib><creatorcontrib>Gerhards, Michael F</creatorcontrib><creatorcontrib>Jansen, Jeroen M</creatorcontrib><creatorcontrib>Acherman, Yair</creatorcontrib><creatorcontrib>Depla, Annekatrien Ctm</creatorcontrib><creatorcontrib>Mannaerts, Guido Hh</creatorcontrib><creatorcontrib>West, Rachel</creatorcontrib><creatorcontrib>Iqbal, Tariq</creatorcontrib><creatorcontrib>Pathmakanthan, Shrikanth</creatorcontrib><creatorcontrib>Howard, Rebecca</creatorcontrib><creatorcontrib>Magill, Laura</creatorcontrib><creatorcontrib>Singh, Baljit</creatorcontrib><creatorcontrib>Htun Oo, Ye</creatorcontrib><creatorcontrib>Negpodiev, Dmitri</creatorcontrib><creatorcontrib>Dijkgraaf, Marcel Gw</creatorcontrib><creatorcontrib>Ram D'Haens, Geert</creatorcontrib><creatorcontrib>Bemelman, Willem A</creatorcontrib><title>The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019)</title><title>BMC surgery</title><addtitle>BMC Surg</addtitle><description>Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-term efficacy of appendectomy to maintain remission in patients with UC, and to establish the acceptability and cost-effectiveness of the intervention compared to standard treatment.
These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission. Patients will then be randomised 1:1 to a control group (maintenance 5-ASA treatment, no appendectomy) or elective laparoscopic appendectomy plus maintenance treatment. The primary outcome measure is the one year cumulative UC relapse rate - defined both clinically and endoscopically as a total Mayo-score ≥5 with endoscopic subscore of 2 or 3. Secondary outcomes that will be assessed include the number of relapses per patient at 12 months, the time to first relapse, health related quality of life and treatment costs, and number of colectomies in each arm.
The ACCURE and ACCURE-UK trials will provide evidence on the role and acceptability of appendectomy in the treatment of ulcerative colitis and the effects of appendectomy on the disease course.
NTR2883 ; ISRCTN56523019.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Appendectomy - methods</subject><subject>Clinical Protocols</subject><subject>Colitis, Ulcerative - surgery</subject><subject>Female</subject><subject>Humans</subject><subject>Laparoscopy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Pilot Projects</subject><subject>Prospective Studies</subject><subject>Quality of Life</subject><subject>Recurrence</subject><subject>Study Protocol</subject><subject>Treatment Outcome</subject><issn>1471-2482</issn><issn>1471-2482</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVUsFu1DAUjBCIlsIHcEE-thKB2E5imwNSFRWoqIq07J4tr_NMjZw42E5FP5Z_wdndVu3J9nsz8-bJUxRvcfUBY95-jJhwQcsKN2VVYVbiZ8UxrhkuSc3J80f3o-JVjL8XDG-al8URaThnjIvj4t_6BtB5121WF2UKVrlPKOUKGAM6IW-QmiYY-_zwwx3y466rnR2tVg5pP4cIC2x2GoJK9jZ3vbPJxvdIoaDG3g82Qo_smCCMGeHHTBxml6yGpYZ2Y9Hp9XpFOKdnKHN2Uw6uNt_RwdgTPfi703Noss6ne5HLn6tufd20DaEVFmevixdGuQhvDudJsflyse6-lVc_vl5251elpkKkUrdM895QDWpLTW0oNw0Y0mhSU-BGGcUMq6jmWyNqAX2rOBGAcVtr2DZC0JPi8153mrcD9MtiQTk5BTuocCe9svJpZ7Q38pe_lTUVNLvNAqcHgeD_zBCTzFtqcE6N4OcoccvqlrOW0AzFe6gOPsYA5mEMruQSC7mPhcyxkMuXS5w57x77e2Dc54D-B4lrtjY</recordid><startdate>20150318</startdate><enddate>20150318</enddate><creator>Gardenbroek, Tjibbe J</creator><creator>Pinkney, Thomas D</creator><creator>Sahami, Saloomeh</creator><creator>Morton, Dion G</creator><creator>Buskens, Christianne J</creator><creator>Ponsioen, Cyriel Y</creator><creator>Tanis, Pieter J</creator><creator>Löwenberg, Mark</creator><creator>van den Brink, Gijs R</creator><creator>Broeders, Ivo Amj</creator><creator>Pullens, Paul Hjm</creator><creator>Seerden, Tom</creator><creator>Boom, Maarten J</creator><creator>Mallant-Hent, Rosalie C</creator><creator>Pierik, Robert Egjm</creator><creator>Vecht, Juda</creator><creator>Sosef, Meindert N</creator><creator>van Nunen, Annick B</creator><creator>van Wagensveld, Bart A</creator><creator>Stokkers, Pieter Cf</creator><creator>Gerhards, Michael F</creator><creator>Jansen, Jeroen M</creator><creator>Acherman, Yair</creator><creator>Depla, Annekatrien Ctm</creator><creator>Mannaerts, Guido Hh</creator><creator>West, Rachel</creator><creator>Iqbal, Tariq</creator><creator>Pathmakanthan, Shrikanth</creator><creator>Howard, Rebecca</creator><creator>Magill, Laura</creator><creator>Singh, Baljit</creator><creator>Htun Oo, Ye</creator><creator>Negpodiev, Dmitri</creator><creator>Dijkgraaf, Marcel Gw</creator><creator>Ram D'Haens, Geert</creator><creator>Bemelman, Willem A</creator><general>BioMed Central</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20150318</creationdate><title>The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019)</title><author>Gardenbroek, Tjibbe J ; Pinkney, Thomas D ; Sahami, Saloomeh ; Morton, Dion G ; Buskens, Christianne J ; Ponsioen, Cyriel Y ; Tanis, Pieter J ; Löwenberg, Mark ; van den Brink, Gijs R ; Broeders, Ivo Amj ; Pullens, Paul Hjm ; Seerden, Tom ; Boom, Maarten J ; Mallant-Hent, Rosalie C ; Pierik, Robert Egjm ; Vecht, Juda ; Sosef, Meindert N ; van Nunen, Annick B ; van Wagensveld, Bart A ; Stokkers, Pieter Cf ; Gerhards, Michael F ; Jansen, Jeroen M ; Acherman, Yair ; Depla, Annekatrien Ctm ; Mannaerts, Guido Hh ; West, Rachel ; Iqbal, Tariq ; Pathmakanthan, Shrikanth ; Howard, Rebecca ; Magill, Laura ; Singh, Baljit ; Htun Oo, Ye ; Negpodiev, Dmitri ; Dijkgraaf, Marcel Gw ; Ram D'Haens, Geert ; Bemelman, Willem A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c399t-c67c8df3ceab3f4f38f5ef25c243e8fafa7f703c8bf949ed6a829e1164ceb5993</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Appendectomy - methods</topic><topic>Clinical Protocols</topic><topic>Colitis, Ulcerative - surgery</topic><topic>Female</topic><topic>Humans</topic><topic>Laparoscopy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Pilot Projects</topic><topic>Prospective Studies</topic><topic>Quality of Life</topic><topic>Recurrence</topic><topic>Study Protocol</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gardenbroek, Tjibbe J</creatorcontrib><creatorcontrib>Pinkney, Thomas D</creatorcontrib><creatorcontrib>Sahami, Saloomeh</creatorcontrib><creatorcontrib>Morton, Dion G</creatorcontrib><creatorcontrib>Buskens, Christianne J</creatorcontrib><creatorcontrib>Ponsioen, Cyriel Y</creatorcontrib><creatorcontrib>Tanis, Pieter J</creatorcontrib><creatorcontrib>Löwenberg, Mark</creatorcontrib><creatorcontrib>van den Brink, Gijs R</creatorcontrib><creatorcontrib>Broeders, Ivo Amj</creatorcontrib><creatorcontrib>Pullens, Paul Hjm</creatorcontrib><creatorcontrib>Seerden, Tom</creatorcontrib><creatorcontrib>Boom, Maarten J</creatorcontrib><creatorcontrib>Mallant-Hent, Rosalie C</creatorcontrib><creatorcontrib>Pierik, Robert Egjm</creatorcontrib><creatorcontrib>Vecht, Juda</creatorcontrib><creatorcontrib>Sosef, Meindert N</creatorcontrib><creatorcontrib>van Nunen, Annick B</creatorcontrib><creatorcontrib>van Wagensveld, Bart A</creatorcontrib><creatorcontrib>Stokkers, Pieter Cf</creatorcontrib><creatorcontrib>Gerhards, Michael F</creatorcontrib><creatorcontrib>Jansen, Jeroen M</creatorcontrib><creatorcontrib>Acherman, Yair</creatorcontrib><creatorcontrib>Depla, Annekatrien Ctm</creatorcontrib><creatorcontrib>Mannaerts, Guido Hh</creatorcontrib><creatorcontrib>West, Rachel</creatorcontrib><creatorcontrib>Iqbal, Tariq</creatorcontrib><creatorcontrib>Pathmakanthan, Shrikanth</creatorcontrib><creatorcontrib>Howard, Rebecca</creatorcontrib><creatorcontrib>Magill, Laura</creatorcontrib><creatorcontrib>Singh, Baljit</creatorcontrib><creatorcontrib>Htun Oo, Ye</creatorcontrib><creatorcontrib>Negpodiev, Dmitri</creatorcontrib><creatorcontrib>Dijkgraaf, Marcel Gw</creatorcontrib><creatorcontrib>Ram D'Haens, Geert</creatorcontrib><creatorcontrib>Bemelman, Willem A</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>BMC surgery</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gardenbroek, Tjibbe J</au><au>Pinkney, Thomas D</au><au>Sahami, Saloomeh</au><au>Morton, Dion G</au><au>Buskens, Christianne J</au><au>Ponsioen, Cyriel Y</au><au>Tanis, Pieter J</au><au>Löwenberg, Mark</au><au>van den Brink, Gijs R</au><au>Broeders, Ivo Amj</au><au>Pullens, Paul Hjm</au><au>Seerden, Tom</au><au>Boom, Maarten J</au><au>Mallant-Hent, Rosalie C</au><au>Pierik, Robert Egjm</au><au>Vecht, Juda</au><au>Sosef, Meindert N</au><au>van Nunen, Annick B</au><au>van Wagensveld, Bart A</au><au>Stokkers, Pieter Cf</au><au>Gerhards, Michael F</au><au>Jansen, Jeroen M</au><au>Acherman, Yair</au><au>Depla, Annekatrien Ctm</au><au>Mannaerts, Guido Hh</au><au>West, Rachel</au><au>Iqbal, Tariq</au><au>Pathmakanthan, Shrikanth</au><au>Howard, Rebecca</au><au>Magill, Laura</au><au>Singh, Baljit</au><au>Htun Oo, Ye</au><au>Negpodiev, Dmitri</au><au>Dijkgraaf, Marcel Gw</au><au>Ram D'Haens, Geert</au><au>Bemelman, Willem A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019)</atitle><jtitle>BMC surgery</jtitle><addtitle>BMC Surg</addtitle><date>2015-03-18</date><risdate>2015</risdate><volume>15</volume><issue>1</issue><spage>30</spage><epage>30</epage><pages>30-30</pages><artnum>30</artnum><issn>1471-2482</issn><eissn>1471-2482</eissn><abstract>Over the past 20 years evidence has accumulated confirming the immunomodulatory role of the appendix in ulcerative colitis (UC). This led to the idea that appendectomy might alter the clinical course of established UC. The objective of this body of research is to evaluate the short-term and medium-term efficacy of appendectomy to maintain remission in patients with UC, and to establish the acceptability and cost-effectiveness of the intervention compared to standard treatment.
These paired phase III multicenter prospective randomised studies will include patients over 18 years of age with an established diagnosis of ulcerative colitis and a disease relapse within 12 months prior to randomisation. Patients need to have been medically treated until complete clinical (Mayo score <3) and endoscopic (Mayo score 0 or 1) remission. Patients will then be randomised 1:1 to a control group (maintenance 5-ASA treatment, no appendectomy) or elective laparoscopic appendectomy plus maintenance treatment. The primary outcome measure is the one year cumulative UC relapse rate - defined both clinically and endoscopically as a total Mayo-score ≥5 with endoscopic subscore of 2 or 3. Secondary outcomes that will be assessed include the number of relapses per patient at 12 months, the time to first relapse, health related quality of life and treatment costs, and number of colectomies in each arm.
The ACCURE and ACCURE-UK trials will provide evidence on the role and acceptability of appendectomy in the treatment of ulcerative colitis and the effects of appendectomy on the disease course.
NTR2883 ; ISRCTN56523019.</abstract><cop>England</cop><pub>BioMed Central</pub><pmid>25887789</pmid><doi>10.1186/s12893-015-0017-1</doi><tpages>1</tpages><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; DOAJ Directory of Open Access Journals; SpringerLink Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central; PubMed Central Open Access; Springer Nature OA Free Journals |
subjects | Adult Aged Aged, 80 and over Appendectomy - methods Clinical Protocols Colitis, Ulcerative - surgery Female Humans Laparoscopy Male Middle Aged Pilot Projects Prospective Studies Quality of Life Recurrence Study Protocol Treatment Outcome |
title | The ACCURE-trial: the effect of appendectomy on the clinical course of ulcerative colitis, a randomised international multicenter trial (NTR2883) and the ACCURE-UK trial: a randomised external pilot trial (ISRCTN56523019) |
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