Analysis Of Early Weight Loss Effect And Safety Of Swallowable Intragastric Balloon In The Treatment Of Obesity

Background: The intragastric balloon is popular among obese patients because of its non-invasive procedure and exact weight reduction efficacy,but no similar intragastric balloon product has been approved for use in China today.Currently,the domestic Spheria^TM swallowable intragastric balloon is in a multicenter clinical trial in China.Objective: As one of the main research centers,this study aims to investigate the efficacy and safety of a domestic swallowable intragastric balloon for early weight loss in obese patients.Methods: Twenty obese patients who underwent domestic swallowable intragastric balloon bariatric surgery at the Third Xiangya Hospital of Central South University from September 2021 to April 2022 were used as the study subjects,excluding 3 cases due to premature rupture of the intragastric balloon,premature removal of the balloon intolerance and failed placement,and a total of 17 obese patients completed follow-up of the swallowable intragastric balloon at 12 weeks after surgery.Statistical methods were used to analyze the changes of patients’ operation time,hospital days and weight-related indexes before and after surgery.Results: The mean preoperative weight of these patients who received a domestic swallowable intragastric balloon was（88.0±10.2）kg and the mean BMI was（31.2±2.2）kg/m².These patients experienced common adverse effects postoperatively and were discharged successfully after routine symptomatic treatment.The average swallowable intragastric balloon placement procedure time was（27.3±11.2）min and the average postoperative hospital stay was（3.4±1.0）days.The length of surgery tended to decrease slightly with the increase in the number of placement cases.All patients showed a decreasing trend in weight and BMI over time,while postoperative TWL% and EWL% showed an increasing trend over time.Compared with the preoperative period,the mean postoperative TWL%at 4 weeks and TWL% at 12 weeks were（5.8±1.9）% and（7.7±2.7）%,respectively,and the median（interquartile spacing）TWL% at 8 weeks was5.7（3.3）%,both significant（p<0.05）;the mean postoperative EWL% at 4weeks and EWL% at 12 weeks were（20.4±6.4）% and（27.3±8.1）%,respectively,and the median（interquartile spacing）EWL% at 8 weeks postoperatively was 20.7（13.8）%,both of which were significant（p<0.05）.Among the 20 cases of intragastric balloon placement,there were no serious adverse events at 3 months postoperatively,except for one patient who declared a serious adverse event due to failed placement.Conclusion: Domestic swallowable intragastric balloons are effective and safe for early weight loss in the treatment of obesity,but long-term effects and safety need further observation.