{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T04:02:19Z","timestamp":1769918539908,"version":"3.49.0"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2011,9,16]],"date-time":"2011-09-16T00:00:00Z","timestamp":1316131200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Re-use of this article is permitted is accordance with the Terms and Conditions set out at. [http:\/\/wileyonlinelibrary.com\/onlineopen#OnlineOpen_Terms]"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2011,10,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Various injectable bulking agents have been used for the treatment of faecal incontinence (FI). However, encouraging early results are not maintained over time. This study aimed to assess short- and medium-term results of a new bulking agent for the treatment of FI.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>The Gatekeeper\u2122 prosthesis comprises a thin solid polyacrylonitrile cylinder that becomes thicker, shorter and softer within 24 h after implantation. Fourteen patients with FI underwent treatment with Gatekeeper\u2122 under local anaesthesia. Four prostheses were implanted in the intersphincteric space in each patient, under endoanal ultrasound guidance. Number of episodes of major FI, Cleveland Clinic FI score (CCFIS), Vaizey score, anorectal manometry, endoanal ultrasonography (EUS), health status and quality of life (Short Form 36 and Faecal Incontinence Quality of Life questionnaires) were assessed before and after treatment.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Mean(s.d.) follow-up was 33\u00b75(12\u00b74) months. There were no complications. There was a significant decrease in major FI episodes from 7\u00b71(7\u00b74) per week at baseline to 1\u00b74(4\u00b70), 1\u00b70(3\u00b72) and 0\u00b74(0\u00b76) per week respectively at 1-month, 3-month and last follow-up (P = 0\u00b7002). CCFIS improved significantly from 12\u00b77(3\u00b73) to 4\u00b71(3\u00b70), 3\u00b79(2\u00b76) and 5\u00b71(3\u00b70) respectively (P &amp;lt; 0\u00b7001), and Vaizey score from 15\u00b74(3\u00b73) to 7\u00b71(3\u00b79), 4\u00b77(3\u00b70) and 6\u00b79(5\u00b70) respectively (P = 0\u00b7010). Soiling and ability to postpone defaecation improved significantly, and patients reported significant improvement in health status and quality of life. At follow-up, manometric parameters had not changed and EUS did not demonstrate any prosthesis dislocation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The Gatekeeper\u2122 anal implant seemed safe, reliable and effective. Initial clinical improvement was maintained over time, and follow-up data were encouraging.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1002\/bjs.7699","type":"journal-article","created":{"date-parts":[[2011,9,16]],"date-time":"2011-09-16T15:32:51Z","timestamp":1316187171000},"page":"1644-1652","source":"Crossref","is-referenced-by-count":69,"title":["Novel bulking agent for faecal incontinence"],"prefix":"10.1093","volume":"98","author":[{"given":"C","family":"Ratto","sequence":"first","affiliation":[{"name":"Department of Surgical Sciences, Catholic University, Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"A","family":"Parello","sequence":"additional","affiliation":[{"name":"Department of Surgical Sciences, Catholic University, Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L","family":"Donisi","sequence":"additional","affiliation":[{"name":"Department of Surgical Sciences, Catholic University, Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F","family":"Litta","sequence":"additional","affiliation":[{"name":"Department of Surgical Sciences, Catholic University, Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"V","family":"De Simone","sequence":"additional","affiliation":[{"name":"Department of Surgical Sciences, Catholic University, Rome, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L","family":"Spazzafumo","sequence":"additional","affiliation":[{"name":"Centre of Statistics, Istituto Nazionale di Ricovero e Cura per Anziani, Ancona, Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P","family":"Giordano","sequence":"additional","affiliation":[{"name":"Department of Surgery, Whipps Cross University Hospital, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2011,9,16]]},"reference":[{"key":"2021070906434207500_bib1","first-page":"159","article-title":"Polytetrafluoroethylene injection for the treatment of partial fecal incontinence","volume":"78","author":"Shafik","year":"1993","journal-title":"Int Surg"},{"key":"2021070906434207500_bib2","doi-asserted-by":"crossref","first-page":"583","DOI":"10.1007\/BF02054115","article-title":"Perianal injection of autologous fat for treatment of sphincteric incontinence","volume":"38","author":"Shafik","year":"1995","journal-title":"Dis Colon Rectum"},{"key":"2021070906434207500_bib3","doi-asserted-by":"crossref","first-page":"978","DOI":"10.1046\/j.1365-2168.1998.00751.x","article-title":"Glutaraldehyde cross-linked collagen in the treatment of faecal incontinence","volume":"85","author":"Kumar","year":"1998","journal-title":"Br J Surg"},{"key":"2021070906434207500_bib4","doi-asserted-by":"crossref","first-page":"595","DOI":"10.1007\/BF02234337","article-title":"Internal anal sphincter augmentation for fecal incontinence using injectable silicone biomaterial","volume":"44","author":"Malouf","year":"2001","journal-title":"Dis Colon Rectum"},{"key":"2021070906434207500_bib5","doi-asserted-by":"crossref","first-page":"237","DOI":"10.1046\/j.1365-2036.2003.01668.x","article-title":"Preliminary evaluation of an injectable anal sphincter bulking agent (Durasphere) in the management of faecal incontinence","volume":"18","author":"Davis","year":"2003","journal-title":"Aliment Pharmacol Ther"},{"key":"2021070906434207500_bib6","first-page":"569","article-title":"Initial clinical results using Coaptite for the treatment of fecal incontinence","volume":"47","author":"Ganio","year":"2004","journal-title":"Dis Colon Rectum"},{"key":"2021070906434207500_bib7","doi-asserted-by":"crossref","first-page":"268","DOI":"10.1111\/j.1463-1318.2007.01318.x","article-title":"Pilot study of two new injectable bulking agents for the treatment of faecal incontinence","volume":"10","author":"Maeda","year":"2008","journal-title":"Colorectal Dis"},{"key":"2021070906434207500_bib8","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1007\/BF02050307","article-title":"Etiology and management of faecal incontinence","volume":"36","author":"Jorge","year":"1993","journal-title":"Dis Colon Rectum"},{"key":"2021070906434207500_bib9","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1136\/gut.44.1.77","article-title":"Prospective comparison of faecal incontinence grading systems","volume":"44","author":"Vaizey","year":"1999","journal-title":"Gut"},{"key":"2021070906434207500_bib10","doi-asserted-by":"crossref","first-page":"473","DOI":"10.1097\/00005650-199206000-00002","article-title":"The MOS 36-item short-form health survey (SF-36). 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