{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T06:05:36Z","timestamp":1791525936694,"version":"4.3.4"},"reference-count":15,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2018,2,2]],"date-time":"2018-02-02T00:00:00Z","timestamp":1517529600000},"content-version":"vor","delay-in-days":1,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100007031","name":"LifeCell","doi-asserted-by":"publisher","award":["Medical education grant"],"award-info":[{"award-number":["Medical education grant"]}],"id":[{"id":"10.13039\/100007031","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Colorectal Disease"],"published-print":{"date-parts":[[2018,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Closure of complex and contaminated abdominal wounds is challenging and carries risks, including wound dehiscence and incisional hernia. Hernia formation at closed stoma sites occurs in up to 30% of patients. Use of biological meshes in these situations may provide a safe method of reducing these complications, especially long\u2010term incisional hernias.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>The Reinforcement of Closure of Stoma Site (<jats:styled-content style=\"fixed-case\">ROCSS<\/jats:styled-content>) study is a Phase <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content> multicentre randomized controlled trial (<jats:styled-content style=\"fixed-case\">RCT<\/jats:styled-content>) with an internal feasibility study. The primary objective of <jats:styled-content style=\"fixed-case\">ROCSS<\/jats:styled-content> is to assess whether a biological mesh (collagen tissue matrix) reduces the incidence of clinically detectable stoma closure site hernias at 2\u00a0years compared with standard closure techniques. Patients will be randomized in a 1:1 ratio to either standard suture (nonmesh) closure or closure with an intra\u2010abdominal biological mesh reinforcement. Patients and outcome assessors are masked to treatment allocation. <jats:styled-content style=\"fixed-case\">ROCSS<\/jats:styled-content> aims to recruit 560 patients, with an option to recruit to 790 patients to increase power. The primary outcome measure is the occurrence of clinically detectable hernias years 2\u00a0years postrandomization. The secondary outcome measures are the radiological hernia rate at 1\u00a0year, incidence of symptomatic hernia, the surgical complication\/re\u2010intervention rate, quality of life, postoperative pain and cost\u2013benefit analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">ROCSS<\/jats:styled-content> is a multicentre <jats:styled-content style=\"fixed-case\">RCT<\/jats:styled-content> assessing the placement of a biological mesh at the site of stoma closure on clinical hernia rate. Our hypothesis is that reinforcing the stoma closure site with a collagen mesh is superior to the standard technique in reducing the risk of herniation at 2\u00a0years. These findings could influence future closure of stomas and other complex and\/or contaminated abdominal wounds in settings around the world.<\/jats:p><\/jats:sec>","DOI":"10.1111\/codi.13997","type":"journal-article","created":{"date-parts":[[2018,1,4]],"date-time":"2018-01-04T02:33:09Z","timestamp":1515033189000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Randomized controlled trial of standard closure of a stoma site <i>vs<\/i> biological mesh reinforcement: study protocol of the ROCSS trial"],"prefix":"10.1111","volume":"20","author":[{"name":"the Reinforcement of Closure of Stoma Site (ROCSS) Collaborative and the West Midlands Research Collaborative","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,2,2]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjsurg.2006.08.017"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10350-006-0681-4"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10029-008-0355-3"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10029-008-0378-9"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00268-006-0218-y"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jamcollsurg.2005.06.002"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00384-009-0660-z"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00268-012-1474-7"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/bjs.4220"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jamcollsurg.2010.06.111"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10029-008-0383-z"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00464-010-1534-8"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c332"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1111\/codi.13310"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.surge.2012.01.001"}],"container-title":["Colorectal Disease"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fcodi.13997","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/codi.13997","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,17]],"date-time":"2023-09-17T12:01:22Z","timestamp":1694952082000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/codi.13997"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,2]]},"references-count":15,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2018,2]]}},"alternative-id":["10.1111\/codi.13997"],"URL":"https:\/\/doi.org\/10.1111\/codi.13997","archive":["Portico"],"relation":{},"ISSN":["1462-8910","1463-1318"],"issn-type":[{"value":"1462-8910","type":"print"},{"value":"1463-1318","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,2]]},"assertion":[{"value":"2017-07-12","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2017-09-14","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2018-02-02","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}