{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,11]],"date-time":"2026-11-11T06:11:43Z","timestamp":1794377503502,"version":"4.9.0"},"reference-count":17,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,12,1]],"date-time":"2023-12-01T00:00:00Z","timestamp":1701388800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,12,1]],"date-time":"2023-12-01T00:00:00Z","timestamp":1701388800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["OBES SURG"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Intra-gastric balloons (IGB) are a mainstay of endoscopic treatment of overweight and obesity. In recent years, an IGB which can remain in situ for 12 months has been developed. The current study aimed to analyse the safety and efficacy of this 12-month IGB.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Consecutive patients receiving the Orbera 365\n                      <jats:sup>TM<\/jats:sup>\n                      IGB (Apollo Endosurgery, TX, USA) between September 2017 and August 2021 were included in a prospective database. Patients received regular follow-up consultations followed by endoscopic removal at 12 months. Demographic data along with weight loss data were collected. All adverse events were recorded.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In total, 1149 patients were included in the study. A majority of the patients were female (87.13%). Median body mass index (BMI) prior to insertion was 36.30 kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      (IQR 32.60\u201340.00 kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ). Median absolute weight loss for all patients was 11.36 kg (IQR 6.70\u201316.82 kg). There was ongoing sustained weight loss until device removal at week 52. For patients with a weight recording at point of IGB removal, median weight loss was greater (15.88 kg, IQR 10.43\u201321.72) with percentage total body weight loss of 15.38% (IQR 10.99\u201321.77) and excess weight loss of 53.99% (IQR 32.44\u201376.30). Increased patient engagement with post-procedural follow-up was associated with increased weight loss (\n                      <jats:italic>p<\/jats:italic>\n                      &lt;0.001). There were 60 total complications (5.22%). Fifty patients required balloon removal due to intolerance. There were eight cases of balloon rupture. There were only two severe complications (0.17%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The current study has confirmed safety of this IGB at 12 months with adverse events comparable to published literature. Weight loss increased up until the point of removal at 12 months.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Graphical Abstract<\/jats:title>\n                  <\/jats:sec>","DOI":"10.1007\/s11695-023-06953-0","type":"journal-article","created":{"date-parts":[[2023,12,1]],"date-time":"2023-12-01T01:02:51Z","timestamp":1701392571000},"page":"176-182","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Safety and Efficacy of 12-Month Intra-gastric Balloon\u2014Series of over 1100 Patients"],"prefix":"10.1007","volume":"34","author":[{"given":"Tom","family":"Wiggins","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ojasvi","family":"Sharma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasmin","family":"Sarfaraz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather","family":"Fry","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Baker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2797-2569","authenticated-orcid":false,"given":"Rishi","family":"Singhal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,12,1]]},"reference":[{"key":"6953_CR1","unstructured":"World Health Organisation. Obesity and overweight. Available from: https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/obesity-and-overweight [Last accessed 27th September 2023]."},{"key":"6953_CR2","unstructured":"House of Commons. Obesity Statistics (Briefing Paper Number 3336). 2019. Available from https:\/\/commonslibrary.parliament.uk\/research-briefings\/sn03336\/ [Last accessed 27th September 2023]."},{"issue":"3","key":"6953_CR3","doi-asserted-by":"publisher","first-page":"219","DOI":"10.1111\/joim.12012","volume":"273","author":"L Sj\u00f6str\u00f6m","year":"2013","unstructured":"Sj\u00f6str\u00f6m L. Review of the key results from the Swedish Obese Subjects (SOS) trial - a prospective controlled intervention study of bariatric surgery. J Intern Med. 2013;273(3):219\u201334.","journal-title":"J Intern Med."},{"issue":"7","key":"6953_CR4","doi-asserted-by":"publisher","first-page":"641","DOI":"10.1056\/NEJMoa1600869","volume":"376","author":"PR Schauer","year":"2017","unstructured":"Schauer PR, Bhatt DL, Kirwan JP, et al. Bariatric surgery versus intensive medical therapy for diabetes \u2014 5-year outcomes. N Engl J Med. 2017;376(7):641\u201351.","journal-title":"N Engl J Med."},{"key":"6953_CR5","first-page":"7","volume":"353","author":"R Welbourn","year":"2016","unstructured":"Welbourn R, Le Roux CW, Owen-Smith A, et al. Why the NHS should do more bariatric surgery; how much should we do? BMJ. 2016;353:7\u201311.","journal-title":"BMJ."},{"issue":"12","key":"6953_CR6","doi-asserted-by":"publisher","first-page":"2060","DOI":"10.1016\/j.soard.2019.05.024","volume":"15","author":"PR Armijo","year":"2019","unstructured":"Armijo PR, Pokala B, Flores L, et al. Patients undergoing intragastric balloon achieve approximately 50% of their target weight loss in the first month postoperatively: an MBSAQIP analysis. Surg Obes Relat Dis. 2019;15(12):2060\u20135.","journal-title":"Surg Obes Relat Dis"},{"issue":"2","key":"6953_CR7","doi-asserted-by":"publisher","first-page":"430","DOI":"10.1016\/j.soard.2015.10.074","volume":"12","author":"JJ Gleysteen","year":"2016","unstructured":"Gleysteen JJ. A history of intragastric balloons. Surg Obes Relat Dis. 2016;12(2):430\u20135.","journal-title":"Surg Obes Relat Dis."},{"issue":"5","key":"6953_CR8","doi-asserted-by":"publisher","first-page":"1649","DOI":"10.1007\/s11695-022-06005-z","volume":"32","author":"A Chow","year":"2022","unstructured":"Chow A, Mocanu V, Verhoeff K, Switzer N, Birch D, Karmali S. Trends in the utilization of intragastric balloons: a 5-year analysis of the MBSAQIP Registry. Obes Surg. 2022;32(5):1649\u201357.","journal-title":"Obes Surg"},{"issue":"7","key":"6953_CR9","doi-asserted-by":"publisher","first-page":"2743","DOI":"10.1007\/s11695-020-04558-5","volume":"30","author":"PST Kotinda A","year":"2020","unstructured":"Kotinda A PST, Turiani Hourneaux de Moura D, Braga Ribeiro I, et al. Efficacy of intragastric balloons for weight loss in overweight and obese adults: a systematic review and meta-analysis of randomized controlled trials. Obes Surg. 2020;30(7):2743\u201353.","journal-title":"Obes Surg"},{"issue":"12","key":"6953_CR10","doi-asserted-by":"publisher","first-page":"4892","DOI":"10.1007\/s11695-020-04985-4","volume":"30","author":"RJ Fittipaldi-Fernandez","year":"2020","unstructured":"Fittipaldi-Fernandez RJ, Zotarelli-Filho IJ, Diestel CF, et al. Intragastric balloon: a retrospective evaluation of 5874 patients on tolerance, complications, and efficacy in different degrees of overweight. Obes Surg. 2020;30(12):4892\u20138.","journal-title":"Obes Surg"},{"key":"6953_CR11","unstructured":"Joint Advisory Group on Gastrointestinal Endoscopy (JAG). Available from: https:\/\/www.thejag.org.uk\/ [Last accessed 27th September 2023]."},{"issue":"9","key":"6953_CR12","doi-asserted-by":"publisher","first-page":"2952","DOI":"10.1007\/s11695-019-03937-x","volume":"29","author":"R Ienca","year":"2019","unstructured":"Ienca R, Giardiello C, Scozzarro A, et al. Improving nausea and vomiting post-elipse balloon: a novel single-dose regimen of 300 mg netupitant\/0.5 mg palonosetron hydrochloride. Obes Surg. 2019;29(9):2952\u20136.","journal-title":"Obes Surg"},{"issue":"3","key":"6953_CR13","doi-asserted-by":"publisher","first-page":"425","DOI":"10.1016\/j.gie.2015.03.1964","volume":"82","author":"BK Abu Dayyeh","year":"2015","unstructured":"Abu Dayyeh BK, Kumar N, Edmundowicz SA, et al. ASGE Bariatric Endoscopy Task Force systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting endoscopic bariatric therapies Prepared by. Gastrointest Endosc. 2015;82(3):425\u2013438.e5.","journal-title":"Gastrointest Endosc"},{"issue":"5","key":"6953_CR14","doi-asserted-by":"publisher","first-page":"461","DOI":"10.5152\/tjg.2019.17877","volume":"30","author":"A El Haddad","year":"2019","unstructured":"El Haddad A, Rammal MO, Soweid A, et al. Intragastric balloon treatment of obesity: long-term results and patient satisfaction. Turk J Gastroenterol. 2019;30(5):461\u20136.","journal-title":"Turk J Gastroenterol"},{"issue":"2","key":"6953_CR15","doi-asserted-by":"publisher","first-page":"781","DOI":"10.1007\/s11695-020-04986-3","volume":"31","author":"DL Chan","year":"2021","unstructured":"Chan DL, Cruz JR, Mui WL, et al. Outcomes with intra-gastric balloon therapy in BMI < 35 non-morbid obesity: 10-year follow-up study of an RCT. Obes Surg. 2021;31(2):781\u20136.","journal-title":"Obes Surg."},{"issue":"6","key":"6953_CR16","doi-asserted-by":"publisher","first-page":"1249","DOI":"10.1038\/s41366-021-00788-4","volume":"45","author":"CL Haase","year":"2021","unstructured":"Haase CL, Lopes S, Olsen AH, et al. Weight loss and risk reduction of obesity-related outcomes in 0.5 million people: evidence from a UK primary care database. Int J Obes. 2021;45(6):1249\u201358.","journal-title":"Int J Obes"},{"issue":"10","key":"6953_CR17","doi-asserted-by":"publisher","first-page":"2083","DOI":"10.1038\/s41591-022-02026-4","volume":"28","author":"WT Garvey","year":"2022","unstructured":"Garvey WT, Batterham RL, Bhatta M, et al. Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial. Nat Med. 2022;28(10):2083\u201391.","journal-title":"Nat Med."}],"container-title":["Obesity Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11695-023-06953-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11695-023-06953-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11695-023-06953-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,1,10]],"date-time":"2024-01-10T10:29:13Z","timestamp":1704882553000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11695-023-06953-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12,1]]},"references-count":17,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2024,1]]}},"alternative-id":["6953"],"URL":"https:\/\/doi.org\/10.1007\/s11695-023-06953-0","relation":{},"ISSN":["0960-8923","1708-0428"],"issn-type":[{"value":"0960-8923","type":"print"},{"value":"1708-0428","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,12,1]]},"assertion":[{"value":"5 August 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 November 2023","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 November 2023","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 December 2023","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed Consent"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}}]}}