{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T15:41:20Z","timestamp":1791819680151,"version":"4.3.4"},"reference-count":43,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2024,5,15]],"date-time":"2024-05-15T00:00:00Z","timestamp":1715731200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Colorectal Disease"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>Although proximal faecal diversion is standard of care to protect patients with high\u2010risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE\u20101) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE\u20102) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>SAFE\u20102 is a pivotal, multicentre, prospective, open\u2010label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co\u2010primary endpoints are the occurrence of major postoperative complications within 12\u2009months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>SAFE\u20102 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>NCT05010850.<\/jats:p><\/jats:sec>","DOI":"10.1111\/codi.17012","type":"journal-article","created":{"date-parts":[[2024,5,16]],"date-time":"2024-05-16T03:43:46Z","timestamp":1715831026000},"page":"1271-1284","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["<scp>SafeHeal<\/scp> Colovac Colorectal Anastomosis Protection Device evaluation (<scp>SAFE<\/scp>\u20102) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device"],"prefix":"10.1111","volume":"26","author":[{"given":"Elisabeth","family":"Hain","sequence":"first","affiliation":[{"name":"Division of Colon and Rectal Surgery, Department of Surgery Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7601-7464","authenticated-orcid":false,"given":"J\u00e9r\u00e9mie H.","family":"Lef\u00e8vre","sequence":"additional","affiliation":[{"name":"Department of Digestive Surgery Sorbonne University, AP\u2010HP, H\u00f4pital Saint Antoine  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alison","family":"Ricardo","sequence":"additional","affiliation":[{"name":"Division of Colon and Rectal Surgery, Department of Surgery Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sang","family":"Lee","sequence":"additional","affiliation":[{"name":"Division of Colon and Rectal Surgery, Department of Surgery University of Southern California  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Zaghiyan","sequence":"additional","affiliation":[{"name":"Department of Surgery Cedars\u2010Sinai Medical Center  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisabeth","family":"McLemore","sequence":"additional","affiliation":[{"name":"Department of Colon and Rectal Surgery Kaiser Permanente Los Angeles Medical Center  Los Angeles California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danny","family":"Sherwinter","sequence":"additional","affiliation":[{"name":"Department of Surgery Maimonides Medical Center  Brooklyn New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rebecca","family":"Rhee","sequence":"additional","affiliation":[{"name":"Department of Surgery Maimonides Medical Center  Brooklyn New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1029-4797","authenticated-orcid":false,"given":"Matthew","family":"Wilson","sequence":"additional","affiliation":[{"name":"Department of Surgery Dartmouth\u2010Hitchcock Medical Center  Lebanon New Hampshire USA"},{"name":"Geisel School of Medicine Dartmouth College  Hanover New Hampshire USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Martz","sequence":"additional","affiliation":[{"name":"Division of Colon and Rectal Surgery Western Region Northwell\/Lenox Hill Hospital  New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Justin","family":"Maykel","sequence":"additional","affiliation":[{"name":"Division of Colon and Rectal Surgery UMass Memorial Medical Center  Worcester Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Marks","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery Lankenau Medical Center  Wynnewood Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge","family":"Marcet","sequence":"additional","affiliation":[{"name":"Division of Colon and Rectal Surgery, Department of Surgery University of South Florida  Tampa Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philippe","family":"Rouanet","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery Institut du Cancer de Montpellier  Montpellier France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leon","family":"Maggiori","sequence":"additional","affiliation":[{"name":"Department of Visceral and Digestive Surgery Saint Louis Hospital, AP\u2010HP  Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niels","family":"Komen","sequence":"additional","affiliation":[{"name":"Department of Digestive Surgical Oncology and Liver Transplantation University Hospital of Besan\u00e7on  Besan\u00e7on France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9965-0916","authenticated-orcid":false,"given":"Nicolas","family":"De\u00a0Hous","sequence":"additional","affiliation":[{"name":"Department of Digestive Surgical Oncology and Liver Transplantation University Hospital of Besan\u00e7on  Besan\u00e7on France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zaher","family":"Lakkis","sequence":"additional","affiliation":[{"name":"Department of Digestive Surgery Rouen University Hospital  Rouen France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Jacques","family":"Tuech","sequence":"additional","affiliation":[{"name":"Department of Abdominal Surgery Antwerp University Hospital Wilrijkstraat 10  Edegem Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fadi","family":"Attiyeh","sequence":"additional","affiliation":[{"name":"Division of Colon and Rectal Surgery, Department of Surgery Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eddy","family":"Cotte","sequence":"additional","affiliation":[{"name":"Digestive and Oncological Surgery Hopital Lyon Sud  Oullins\u2010Pierre\u2010B\u00e9nite France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Sylla","sequence":"additional","affiliation":[{"name":"Division of Colon and Rectal Surgery, Department of Surgery Icahn School of Medicine at Mount Sinai  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,5,15]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-3-201302050-00583"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21492"},{"key":"e_1_2_12_4_1","unstructured":"https:\/\/www.who.int\/news\u2010room\/fact\u2010sheets\/detail\/cancer."},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa060829"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2006.06.7629"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2168.1999.01216.x"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1097\/DCR.0000000000000396"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0b013e3180603024"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.sla.0000150067.99651.6a"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0000000000001991"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2016.67.6049"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.14740\/jocmr2150w"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.surg.2015.09.011"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jss.2015.11.026"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.3393\/ac.2015.31.3.98"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1186\/s40001-018-0325-x"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12957-017-1149-9"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.6212"},{"key":"e_1_2_12_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijsu.2018.03.001"},{"key":"e_1_2_12_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjsurg.2016.01.025"},{"key":"e_1_2_12_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clcc.2015.07.008"},{"key":"e_1_2_12_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.surg.2015.07.004"},{"key":"e_1_2_12_24_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(07)70047-5"},{"key":"e_1_2_12_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00464-019-07279-8"},{"key":"e_1_2_12_26_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.sla.0000133083.54934.ae"},{"key":"e_1_2_12_27_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.surg.2009.10.012"},{"key":"e_1_2_12_28_1","doi-asserted-by":"publisher","DOI":"10.1097\/00000421-198212000-00014"},{"key":"e_1_2_12_29_1","doi-asserted-by":"publisher","DOI":"10.1177\/15533506211051274"},{"key":"e_1_2_12_30_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-011-9903-x"},{"key":"e_1_2_12_31_1","doi-asserted-by":"publisher","DOI":"10.1097\/SLA.0b013e31824f1c21"},{"key":"e_1_2_12_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.gie.2008.05.057"},{"key":"e_1_2_12_33_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.surg.2008.05.018"},{"key":"e_1_2_12_34_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF02552999"},{"key":"e_1_2_12_35_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF02050930"},{"key":"e_1_2_12_36_1","first-page":"A2812","article-title":"C\u2010seal for prevention of anastomotic leakage following colorectal anastomosis","volume":"155","author":"Morks AN","year":"2011","journal-title":"Ned Tijdschr Geneeskd"},{"key":"e_1_2_12_37_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00384-012-1580-x"},{"key":"e_1_2_12_38_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10151-019-02015-9"},{"key":"e_1_2_12_39_1","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.10534"},{"key":"e_1_2_12_40_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00384-019-03255-9"},{"key":"e_1_2_12_41_1","doi-asserted-by":"publisher","DOI":"10.1111\/codi.15055"},{"key":"e_1_2_12_42_1","doi-asserted-by":"publisher","DOI":"10.1177\/1553350619851670"},{"key":"e_1_2_12_43_1","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.4806"},{"key":"e_1_2_12_44_1","doi-asserted-by":"publisher","DOI":"10.1001\/archsurg.140.3.278"}],"container-title":["Colorectal Disease"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/codi.17012","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,6,27]],"date-time":"2024-06-27T07:50:47Z","timestamp":1719474647000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/codi.17012"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5,15]]},"references-count":43,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2024,6]]}},"alternative-id":["10.1111\/codi.17012"],"URL":"https:\/\/doi.org\/10.1111\/codi.17012","archive":["Portico"],"relation":{},"ISSN":["1462-8910","1463-1318"],"issn-type":[{"value":"1462-8910","type":"print"},{"value":"1463-1318","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5,15]]},"assertion":[{"value":"2023-06-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-03-06","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-05-15","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}