{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T01:29:37Z","timestamp":1760146177489,"version":"build-2065373602"},"reference-count":34,"publisher":"MDPI AG","issue":"20","license":[{"start":{"date-parts":[[2024,10,16]],"date-time":"2024-10-16T00:00:00Z","timestamp":1729036800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Introduction: Although several treatments for faecal incontinence are available, gas incontinence (GI) and soiling are difficult to manage. The aim of this study is to evaluate Gatekeeper\u2122 for this subtype of faecal incontinence. Methods: Prospective single-centre case series. Patients with mainly soiling and\/or GI were treated with polyacrylonitrile prostheses. An evaluation was performed with a 3-week continence diary. St. Mark\u2019s score and a Visual Analogue Scale (VAS) were used to study the patient\u2019s continence perception and surgical satisfaction, at baseline and 1, 3, 6, 12, and 24 months postoperatively. 3D-Endoanal Ultrasound and Anorectal Manometry were performed at baseline and postoperatively. Results: A total of 13 patients were enrolled (11 women), aged (median (IQR)) 62 (13) years, and all implants were uneventful. A significant reduction in soiling and GI episodes was documented at 1 year, 7 (18) baseline days of soiling\/3 weeks vs. 2 (4) (p = 0.002); 13 (13) baseline episodes of GI\/3 weeks vs. 4 (10) (p = 0.01). This improvement was correlated with a significant increase in VAS (0\u201310), 3 (2, 5) baseline vs. 7 (1, 5) (p = 0.03), and maintained throughout the follow-up. There was complete remission or significant improvement defined as &gt;70% reduction in gas and soiling days in 6 patients at 2 years follow-up. Soiling episodes were reduced \u226570% in 8\/11 patients (72.7%). Nine (70%) patients would repeat the treatment. Conclusions: Gatekeeper\u2122 is a safe, minimally invasive treatment for soiling and GI. A significant reduction in soiling and GI was observed in our series, with a better response to soiling. Most of the patients would repeat the treatment. Other studies are needed to confirm these findings in this subgroup of FI patients.<\/jats:p>","DOI":"10.3390\/jcm13206156","type":"journal-article","created":{"date-parts":[[2024,10,16]],"date-time":"2024-10-16T07:58:32Z","timestamp":1729065512000},"page":"6156","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Gatekeeper\u2122 Prostheses Implants in the Anal Canal for Gas Incontinence and Soiling: Long-Term Follow-Up"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1936-5881","authenticated-orcid":false,"given":"Jaume","family":"Tur-Martinez","sequence":"first","affiliation":[{"name":"Department of General Surgery, Hospital Universitari M\u00fatuaTerrassa, Universitat de Barcelona, 08221 Terrassa, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laura","family":"Lagares-Tena","sequence":"additional","affiliation":[{"name":"Department of General Surgery, Hospital Universitari M\u00fatuaTerrassa, Universitat de Barcelona, 08221 Terrassa, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1868-9910","authenticated-orcid":false,"given":"Juan","family":"Hinojosa-Fano","sequence":"additional","affiliation":[{"name":"Department of General Surgery, Hospital Universitari M\u00fatuaTerrassa, Universitat de Barcelona, 08221 Terrassa, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0157-5175","authenticated-orcid":false,"given":"Antonio","family":"Arroyo","sequence":"additional","affiliation":[{"name":"Colorectal Surgery Unit, Department of General Surgery, Hospital Universitario de Elche, Universidad Miguel Hern\u00e1ndez, 03202 Elche, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Albert","family":"Navarro-Luna","sequence":"additional","affiliation":[{"name":"Department of General Surgery, Hospital Universitari M\u00fatuaTerrassa, Universitat de Barcelona, 08221 Terrassa, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6000-2054","authenticated-orcid":false,"given":"Arantxa","family":"Mu\u00f1oz-Duyos","sequence":"additional","affiliation":[{"name":"Department of General Surgery, Hospital Universitari M\u00fatuaTerrassa, Universitat de Barcelona, 08221 Terrassa, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2024,10,16]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"59","DOI":"10.1016\/j.medcli.2010.01.031","article-title":"Prevalence of fecal incontinence and its relationship with bowel habit in patients attended in primary care","volume":"135","author":"Maestre","year":"2010","journal-title":"Med. Clin."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"1589","DOI":"10.1002\/bjs.10298","article-title":"Systematic review of the prevalence of faecal incontinence","volume":"103","author":"Sharma","year":"2016","journal-title":"Br. J. Surg."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"251","DOI":"10.1002\/ueg2.12213","article-title":"Guideline for the diagnosis and treatment of Faecal Incontinence-A UEG\/ESCP\/ESNM\/ESPCG collaboration","volume":"10","author":"Assmann","year":"2022","journal-title":"United Eur. Gastroenterol. J."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"1413","DOI":"10.1007\/s10151-023-02871-6","article-title":"Transanal irrigation in functional bowel disorders and LARS: Short-term results from an Italian national study","volume":"27","author":"Falletto","year":"2023","journal-title":"Tech. Coloproctol."},{"key":"ref_5","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":"ref_6","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":"ref_7","doi-asserted-by":"crossref","first-page":"521","DOI":"10.1002\/bjs.4997","article-title":"Injectable bulking agents for treating faecal incontinence","volume":"92","author":"Vaizey","year":"2005","journal-title":"Br. J. Surg."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"2138","DOI":"10.1007\/s10350-004-0760-3","article-title":"Injectable silicone biomaterial for fecal incontinence caused by internal anal sphincter dysfunction is effective","volume":"47","author":"Tjandra","year":"2004","journal-title":"Dis. Colon Rectum"},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"1125","DOI":"10.1111\/j.1365-2036.2007.03293.x","article-title":"Elastomer implants in faecal incontinence: A blind, randomized placebo-controlled study","volume":"25","author":"Siproudhis","year":"2007","journal-title":"Aliment. Pharmacol. Ther."},{"key":"ref_10","doi-asserted-by":"crossref","unstructured":"Maeda, Y., Laurberg, S., and Norton, C. (2013). Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database Syst. Rev., CD007959.","DOI":"10.1002\/14651858.CD007959.pub3"},{"key":"ref_11","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":"ref_12","unstructured":"Ganio, E., Trompetto, M., Realis Luc, A., and Clerico, G. (2004). Initial clinical results using Coaptite for the treatment of fecal incontinence. Dis. Colon Rectum, 47."},{"key":"ref_13","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":"Color. Dis."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"296","DOI":"10.1111\/j.1463-1318.2009.01828.x","article-title":"Systematic review on the efficacy and safety of injectable bulking agents for passive faecal incontinence","volume":"12","author":"Luo","year":"2010","journal-title":"Color. Dis."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"1526","DOI":"10.1002\/bjs.7645","article-title":"Systematic review of perianal implants in the treatment of faecal incontinence","volume":"98","author":"Hussain","year":"2011","journal-title":"Br. J. Surg."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"203","DOI":"10.1007\/s10151-017-1593-0","article-title":"Midterm outcomes of injectable bulking agents for fecal incontinence: A systematic review and meta-analysis","volume":"21","author":"Hong","year":"2017","journal-title":"Tech. Coloproctol."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1644","DOI":"10.1002\/bjs.7699","article-title":"Novel bulking agent for faecal incontinence","volume":"98","author":"Ratto","year":"2011","journal-title":"Br. J. Surg."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"S31","DOI":"10.4103\/sja.SJA_543_18","article-title":"The STROBE guidelines","volume":"13","author":"Cuschieri","year":"2019","journal-title":"Saudi J. Anaesth."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"290","DOI":"10.1002\/bjs.10050","article-title":"Multicentre observational study of the Gatekeeper for faecal incontinence","volume":"103","author":"Ratto","year":"2016","journal-title":"Br. J. Surg."},{"key":"ref_20","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":"ref_21","doi-asserted-by":"crossref","first-page":"537","DOI":"10.1007\/s10151-022-02630-z","article-title":"An evaluation of the long-term effectiveness of Gatekeeper\u2122 intersphincteric implants for passive faecal incontinence","volume":"26","author":"Jabbar","year":"2022","journal-title":"Tech. Coloproctol."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"963","DOI":"10.1007\/s10151-017-1723-8","article-title":"Outcomes of Gatekeeper TM prosthesis implantation for the treatment of fecal incontinence: A multicenter observational study","volume":"21","author":"Trenti","year":"2017","journal-title":"Tech. Coloproctol."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"407","DOI":"10.1002\/bjs.9740","article-title":"Long-term outcomes of sacral nerve stimulation for faecal incontinence","volume":"102","author":"Altomare","year":"2015","journal-title":"Br. J. Surg."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"793","DOI":"10.1007\/s00384-014-1870-6","article-title":"Baseline factors predictive of patient satisfaction with sacral neuromodulation for idiopathic fecal incontinence","volume":"29","author":"Buntzen","year":"2014","journal-title":"Int. J. Color. Dis."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1177\/1553350618818924","article-title":"Gatekeeper Improves Voluntary Contractility in Patients with Fecal Incontinence","volume":"26","author":"Grossi","year":"2019","journal-title":"Surg. Innov."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"437","DOI":"10.1007\/s00384-016-2742-z","article-title":"Ultrasonographic evidence of Gatekeeper\u2122 prosthesis migration in patients treated for faecal incontinence: A case series","volume":"32","author":"Maestre","year":"2017","journal-title":"Int. J. Color. Dis."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"514","DOI":"10.1097\/DCR.0000000000001559","article-title":"Middle-term Outcomes of Gatekeeper Implantation for Fecal Incontinence","volume":"63","author":"Brusciano","year":"2020","journal-title":"Dis. Colon Rectum"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"608","DOI":"10.1177\/1553350620934932","article-title":"Implantable Agents for Fecal Incontinence: An Age-Matched Retrospective Cohort Analysis of GateKeeper versus SphinKeeper","volume":"27","author":"Grossi","year":"2020","journal-title":"Surg. Innov."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"1316","DOI":"10.1046\/j.1365-2168.2000.01592.x","article-title":"Factors predictive of outcome after surgery for faecal incontinence","volume":"87","author":"Baig","year":"2000","journal-title":"Br. J. Surg."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1007\/BF02237236","article-title":"Fecal Incontinence Quality of Life Scale: Quality of life instrument for patients with fecal incontinence","volume":"43","author":"Rockwood","year":"2000","journal-title":"Dis. Colon Rectum"},{"key":"ref_31","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). I. Conceptual framework and item selection","volume":"30","author":"Ware","year":"1992","journal-title":"Med. Care"},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"706","DOI":"10.1097\/DCR.0000000000001857","article-title":"Implant of Self-Expandable Artificial Anal Sphincter in Patients with Fecal Incontinence Improves External Anal Sphincter Contractility","volume":"64","author":"Litta","year":"2021","journal-title":"Dis. Colon Rectum"},{"key":"ref_33","doi-asserted-by":"crossref","unstructured":"Dawoud, C., Bender, L., Widmann, K.M., Harpain, F., and Riss, S. (2021). Sphinkeeper Procedure for Treating Severe Faecal Incontinence\u2014A Prospective Cohort Study. J. Clin. Med., 10.","DOI":"10.3390\/jcm10214965"},{"key":"ref_34","doi-asserted-by":"crossref","first-page":"484","DOI":"10.1002\/bjs.11558","article-title":"Efficacy of Sphinkeeper\u2122 implant in treating faecal incontinence","volume":"107","author":"Litta","year":"2020","journal-title":"Br. J. Surg."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/13\/20\/6156\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T16:14:09Z","timestamp":1760112849000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/13\/20\/6156"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,10,16]]},"references-count":34,"journal-issue":{"issue":"20","published-online":{"date-parts":[[2024,10]]}},"alternative-id":["jcm13206156"],"URL":"https:\/\/doi.org\/10.3390\/jcm13206156","relation":{},"ISSN":["2077-0383"],"issn-type":[{"type":"electronic","value":"2077-0383"}],"subject":[],"published":{"date-parts":[[2024,10,16]]}}}