{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,20]],"date-time":"2026-06-20T11:06:45Z","timestamp":1781953605058,"version":"3.54.5"},"reference-count":24,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,12,1]],"date-time":"2019-12-01T00:00:00Z","timestamp":1575158400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,12,12]],"date-time":"2019-12-12T00:00:00Z","timestamp":1576108800000},"content-version":"vor","delay-in-days":11,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004690","name":"Minist\u00e8re de la sant\u00e9","doi-asserted-by":"crossref","award":["PHRC-18_0764"],"award-info":[{"award-number":["PHRC-18_0764"]}],"id":[{"id":"10.13039\/501100004690","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Surg"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n<jats:title>Background<\/jats:title>\n<jats:p>There is no quality evidence of the benefit of defunctioning ileostomy (DI) in ileal pouch-anal anastomoses (IPAAs) performed for inflammatory bowel disease (IBD), but most surgical teams currently resort to DI. In the case of a staged procedure with subtotal colectomy first, completion proctectomy with IPAA is performed for healthy patients, namely, after nutritional support, inflammation reduction and immunosuppressive agent weaning. Therefore, the aim of this trial is to assess the need for systematic DI after completion proctectomy and IPAA for IBD.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods\/design<\/jats:title>\n<jats:p>This is a multicenter randomized open trial comparing completion proctectomy and IPAA without (experimental) or with (control) DI in patients presenting with ulcerative colitis or indeterminate colitis. Crohn\u2019s disease patients will not be included. The design is a superiority trial. The main objective is to compare the 6-month global postoperative morbidity, encompassing both surgical and medical complications, between the two groups. The morbidity of DI closure will be included, as appropriate. The sample size calculation is based on the hypothesis that the overall 6-month morbidity rate is 30% in the case of no stoma creation (i.e., experimental group) vs. 55% otherwise (control group). With the alpha risk and power are fixed to 0.05 and 0.80, respectively, and considering a dropout rate of 10%, the objective is set to 194 patients. The secondary objectives are to compare both strategies in terms of morbi-mortality at 6\u2009months and functional results as well as quality of life at 12\u2009months, namely, the 6-month major morbidity and unplanned reoperation rates, 6-month anastomotic leakage rate, 6-month mortality, length of hospital stay, 6-month unplanned readmission rate, quality of life assessed 3 and 12\u2009months from continuity restoration (i.e., either IPAA or stoma closure), functional results assessed 3 and 12\u2009months from continuity restoration, 12-month pouch results, 12-month cost-utility analysis, and 12-month global morbidity.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Discussion<\/jats:title>\n<jats:p>The IDEAL trial is a nationwide multicenter study that will help choose the optimal strategy between DI and no ileostomy in completion proctectomy with IPAA for IBD.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p><jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrial.gov\">ClinicalTrial.gov<\/jats:ext-link>: NCT03872271, date of registration March 13th, 2019.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s12893-019-0657-7","type":"journal-article","created":{"date-parts":[[2019,12,12]],"date-time":"2019-12-12T18:02:35Z","timestamp":1576173755000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Is diverting loop ileostomy necessary for completion proctectomy with ileal pouch-anal anastomosis? A multicenter randomized trial of the GETAID Chirurgie group (IDEAL trial): rationale and design (NCT03872271)"],"prefix":"10.1186","volume":"19","author":[{"name":"GETAID Chirurgie group","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6594-6935","authenticated-orcid":false,"given":"Laura","family":"Beyer-Berjot","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karine","family":"Baumstarck","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandrine","family":"Loubi\u00e8re","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Vicaut","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phane V.","family":"Berdah","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phane","family":"Benoist","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00e9r\u00e9mie H.","family":"Lef\u00e8vre","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,12,12]]},"reference":[{"key":"657_CR1","doi-asserted-by":"publisher","first-page":"2769","DOI":"10.1016\/S0140-6736(17)32448-0","volume":"390","author":"SC Ng","year":"2018","unstructured":"Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2018;390:2769\u201378.","journal-title":"Lancet"},{"key":"657_CR2","doi-asserted-by":"publisher","first-page":"262","DOI":"10.1007\/BF02993607","volume":"159","author":"Restorative proctocolectomy: the Irish experience","year":"1990","unstructured":"Restorative proctocolectomy: the Irish experience. Irish association of Coloproctology. Ir J Med Sci. 1990;159:262\u20135.","journal-title":"Ir J Med Sci"},{"key":"657_CR3","unstructured":"Beyer-Berjot L, Berdah SV. Prise en charge chirurgicale des maladies inflammatoires chroniques de l'intestin : traitement chirurgical de la rectocolite ulc\u00e9roh\u00e9morragique. Techniques chirurgicales - Appareil Digestif. Volume 40\u2013590-A, edn. Edited by Masson E: Elsevier Masson; 2015."},{"key":"657_CR4","doi-asserted-by":"publisher","first-page":"85","DOI":"10.1136\/bmj.2.6130.85","volume":"2","author":"AG Parks","year":"1978","unstructured":"Parks AG, Nicholls RJ. Proctocolectomy without ileostomy for ulcerative colitis. Br Med J. 1978;2:85\u20138.","journal-title":"Br Med J"},{"key":"657_CR5","doi-asserted-by":"publisher","first-page":"406","DOI":"10.1001\/archsurg.143.4.406","volume":"143","author":"GK Weston-Petrides","year":"2008","unstructured":"Weston-Petrides GK, Lovegrove RE, Tilney HS, Heriot AG, Nicholls RJ, Mortensen NJ, Fazio VW, Tekkis PP. Comparison of outcomes after restorative proctocolectomy with or without defunctioning ileostomy. Arch Surg. 2008;143:406\u201312.","journal-title":"Arch Surg"},{"key":"657_CR6","doi-asserted-by":"publisher","first-page":"903","DOI":"10.1002\/bjs.1800790916","volume":"79","author":"SP Grobler","year":"1992","unstructured":"Grobler SP, Hosie KB, Keighley MR. Randomized trial of loop ileostomy in restorative proctocolectomy. Br J Surg. 1992;79:903\u20136.","journal-title":"Br J Surg"},{"key":"657_CR7","doi-asserted-by":"publisher","first-page":"779","DOI":"10.1093\/ecco-jcc\/jjv201","volume":"10","author":"S Sahami","year":"2016","unstructured":"Sahami S, Buskens CJ, Fadok TY, Tanis PJ, de Buck van Overstraeten A, Wolthuis AM, et al. Defunctioning ileostomy is not associated with reduced leakage in Proctocolectomy and Ileal pouch anastomosis surgeries for IBD. J Crohn's Colitis. 2016;10:779\u201385.","journal-title":"J Crohn's Colitis"},{"key":"657_CR8","doi-asserted-by":"publisher","first-page":"766","DOI":"10.1093\/ecco-jcc\/jjw069","volume":"10","author":"E Zittan","year":"2016","unstructured":"Zittan E, Wong-Chong N, Ma GW, McLeod RS, Silverberg MS, Cohen Z. Modified two-stage Ileal pouch-anal anastomosis results in lower rate of anastomotic leak compared with traditional two-stage surgery for ulcerative colitis. J Crohn's Colitis. 2016;10:766\u201372.","journal-title":"J Crohn's Colitis"},{"key":"657_CR9","doi-asserted-by":"publisher","first-page":"218","DOI":"10.1007\/s10350-007-9101-7","volume":"51","author":"A Tsunoda","year":"2008","unstructured":"Tsunoda A, Tsunoda Y, Narita K, Watanabe M, Nakao K, Kusano M. Quality of life after low anterior resection and temporary loop ileostomy. Dis Colon Rectum. 2008;51:218\u201322.","journal-title":"Dis Colon Rectum"},{"key":"657_CR10","doi-asserted-by":"publisher","first-page":"49","DOI":"10.1007\/s00384-011-1276-7","volume":"27","author":"HL van Westreenen","year":"2012","unstructured":"van Westreenen HL, Visser A, Tanis PJ, Bemelman WA. Morbidity related to defunctioning ileostomy closure after ileal pouch-anal anastomosis and low colonic anastomosis. Int J Color Dis. 2012;27:49\u201354.","journal-title":"Int J Color Dis"},{"key":"657_CR11","doi-asserted-by":"publisher","first-page":"118","DOI":"10.1016\/j.dld.2011.09.007","volume":"44","author":"T Hor","year":"2012","unstructured":"Hor T, Zalinski S, Lefevre JH, Shields C, Attal E, Tiret E, Parc Y. Feasibility of laparoscopic restorative proctocolectomy without diverting stoma. Dig Liver Dis. 2012;44:118\u201322.","journal-title":"Dig Liver Dis"},{"key":"657_CR12","doi-asserted-by":"publisher","first-page":"470","DOI":"10.1007\/s10350-006-0509-2","volume":"49","author":"FH Remzi","year":"2006","unstructured":"Remzi FH, Fazio VW, Gorgun E, Ooi BS, Hammel J, Preen M, et al. The outcome after restorative proctocolectomy with or without defunctioning ileostomy. Dis Colon Rectum. 2006;49:470\u20137.","journal-title":"Dis Colon Rectum"},{"key":"657_CR13","doi-asserted-by":"publisher","first-page":"557","DOI":"10.1016\/j.jamcollsurg.2016.12.049","volume":"224","author":"J Samples","year":"2017","unstructured":"Samples J, Evans K, Chaumont N, Strassle P, Sadiq T, Koruda M. Variant two-stage Ileal pouch-anal anastomosis: an innovative and effective alternative to standard resection in ulcerative colitis. J Am Coll Surg. 2017;224:557\u201363.","journal-title":"J Am Coll Surg"},{"key":"657_CR14","doi-asserted-by":"publisher","first-page":"205","DOI":"10.1097\/01.sla.0000133083.54934.ae","volume":"240","author":"D Dindo","year":"2004","unstructured":"Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205\u201313.","journal-title":"Ann Surg"},{"key":"657_CR15","doi-asserted-by":"publisher","first-page":"945","DOI":"10.1002\/bjs.7021","volume":"97","author":"RE Lovegrove","year":"2010","unstructured":"Lovegrove RE, Fazio VW, Remzi FH, Tilney HS, Nicholls RJ, Tekkis PP. Development of a pouch functional score following restorative proctocolectomy. Br J Surg. 2010;97:945\u201351.","journal-title":"Br J Surg"},{"key":"657_CR16","doi-asserted-by":"publisher","first-page":"1727","DOI":"10.1007\/s11136-011-9903-x","volume":"20","author":"M Herdman","year":"2011","unstructured":"Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20:1727\u201336.","journal-title":"Qual Life Res"},{"key":"657_CR17","doi-asserted-by":"publisher","first-page":"849","DOI":"10.1097\/SLA.0000000000001406","volume":"262","author":"Y Parc","year":"2015","unstructured":"Parc Y, Reboul-Marty J, Lefevre JH, Shields C, Chafai N, Tiret E. Restorative Proctocolectomy and Ileal pouch-anal anastomosis. Ann Surg. 2015;262:849\u201353.","journal-title":"Ann Surg"},{"key":"657_CR18","doi-asserted-by":"publisher","first-page":"4","DOI":"10.1016\/j.crohns.2014.08.012","volume":"9","author":"T Oresland","year":"2015","unstructured":"Oresland T, Bemelman WA, Sampietro GM, Spinelli A, Windsor A, Ferrante M, et al. European evidence based consensus on surgery for ulcerative colitis. J Crohn's Colitis. 2015;9:4\u201325.","journal-title":"J Crohn's Colitis"},{"key":"657_CR19","doi-asserted-by":"publisher","first-page":"854","DOI":"10.1016\/S0140-6736(96)91344-6","volume":"347","author":"Y Panis","year":"1996","unstructured":"Panis Y, Poupard B, Nemeth J, Lavergne A, Hautefeuille P, Valleur P. Ileal pouch\/anal anastomosis for Crohn's disease. Lancet. 1996;347:854\u20137.","journal-title":"Lancet"},{"key":"657_CR20","doi-asserted-by":"publisher","first-page":"239","DOI":"10.1007\/s10350-006-0777-x","volume":"50","author":"GE Reese","year":"2007","unstructured":"Reese GE, Lovegrove RE, Tilney HS, Yamamoto T, Heriot AG, Fazio VW, Tekkis PP. The effect of Crohn's disease on outcomes after restorative proctocolectomy. Dis Colon Rectum. 2007;50:239\u201350.","journal-title":"Dis Colon Rectum"},{"key":"657_CR21","doi-asserted-by":"publisher","first-page":"991","DOI":"10.1016\/j.crohns.2012.09.002","volume":"6","author":"A Dignass","year":"2012","unstructured":"Dignass A, Lindsay JO, Sturm A, Windsor A, Colombel JF, Allez M, et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohn's Colitis. 2012;6:991\u20131030.","journal-title":"J Crohn's Colitis"},{"key":"657_CR22","doi-asserted-by":"publisher","first-page":"207","DOI":"10.1097\/SLA.0b013e3180603024","volume":"246","author":"P Matthiessen","year":"2007","unstructured":"Matthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007;246:207\u201314.","journal-title":"Ann Surg"},{"key":"657_CR23","doi-asserted-by":"publisher","first-page":"9","DOI":"10.1186\/s12957-014-0417-1","volume":"13","author":"WL Gu","year":"2015","unstructured":"Gu WL, Wu SW. Meta-analysis of defunctioning stoma in low anterior resection with total mesorectal excision for rectal cancer: evidence based on thirteen studies. World J Surg Oncol. 2015;13:9.","journal-title":"World J Surg Oncol"},{"key":"657_CR24","doi-asserted-by":"publisher","first-page":"649","DOI":"10.1093\/ecco-jcc\/jjx008","volume":"11","author":"F Magro","year":"2017","unstructured":"Magro F, Gionchetti P, Eliakim R, Ardizzone S, Armuzzi A, Barreiro-de Acosta M, et al. Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 1: definitions, diagnosis, extra-intestinal manifestations, pregnancy, Cancer surveillance, surgery, and Ileo-anal pouch disorders. J Crohn's Colitis. 2017;11:649\u201370.","journal-title":"J Crohn's Colitis"}],"container-title":["BMC Surgery"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12893-019-0657-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1186\/s12893-019-0657-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1186\/s12893-019-0657-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,12,11]],"date-time":"2020-12-11T00:21:49Z","timestamp":1607646109000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcsurg.biomedcentral.com\/articles\/10.1186\/s12893-019-0657-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,12]]},"references-count":24,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,12]]}},"alternative-id":["657"],"URL":"https:\/\/doi.org\/10.1186\/s12893-019-0657-7","relation":{},"ISSN":["1471-2482"],"issn-type":[{"value":"1471-2482","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,12]]},"assertion":[{"value":"7 May 2019","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 November 2019","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 December 2019","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"This study was submitted to the ethics committee \u201cCPP Sud-Est 3\u201d on April 30th, 2019; it was approved after minor corrections.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"192"}}