Genco Alfredo, Maselli Roberta, Frangella Francesca, Cipriano Massimiliano, Forestieri Pietro, Delle Piane Daniela, Furbetta Francesco, Micheletto Giancarlo, Ciampaglia Franco, Granelli Paola, Zilli Maurizio, Lorenzo Michele, Di Rocco Giorgio, Giannotti Domenico, Redler Adriano
Laparoscopic Surgical Department, "Umberto I°" General Hospital, Medical School "Sapienza" University, Rome, Italy,
Surg Endosc. 2015 Aug;29(8):2339-43. doi: 10.1007/s00464-014-3957-0. Epub 2014 Dec 6.
Obesity is a major risk factor for several chronic diseases. The BioEnterics(®) Intragastric Balloon (BIB(®)) is used worldwide as a short-term (6 months) treatment in morbid obese patients. However, removal of BIB(®) past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB(®) left in situ for more than 6 months.
A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB(®) after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected.
Six hundred and eleven patients were included. In the majority of cases, patient extended BIB(®) treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI (p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded.
Extending the duration of BIB(®) use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications.
肥胖是多种慢性疾病的主要危险因素。BioEnterics（®）胃内球囊（BIB（®））在全球范围内被用作病态肥胖患者的短期（6个月）治疗方法。然而，在临床实践中，超过6个月后取出BIB（®）的情况很常见，这通常是由患者因素导致的。本意大利多中心队列研究的目的是评估BIB（®）原位留置超过6个月的安全性和有效性。
共有8个意大利中心参与了该研究。参与中心收到一份标准化问卷，旨在收集安全性和有效性数据。记录体重减轻数据，以及6个月后BIB（®）的取出日期和原因。还收集了不良事件，包括死亡率和并发症、操作者的主观技术记录和发现，以及取出过程中的困难。
纳入611例患者。在大多数情况下，患者因体重减轻效果满意而延长了BIB（®）治疗（44%）。6个月时，所有患者的BMI在统计学上均低于初始BMI（p<0.001）。与6个月内的结果相比，在长达15个月时取出BIB的患者中，BMI降低百分比有不显著的增加趋势。未记录到重大并发症。
将BIB（®）的使用时间延长至14个月可安全地维持体重减轻和饱腹感，效果优于6个月，且无并发症。
