Safety and Efficacy of 12-Month Intra-gastric Balloon-Series of over 1100 Patients.

BACKGROUND: 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. METHODS: Consecutive patients receiving the Orbera 365TM 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. RESULTS: 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/m2 (IQR 32.60-40.00 kg/m2). Median absolute weight loss for all patients was 11.36 kg (IQR 6.70-16.82 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 10.43-21.72) with percentage total body weight loss of 15.38% (IQR 10.99-21.77) and excess weight loss of 53.99% (IQR 32.44-76.30). Increased patient engagement with post-procedural follow-up was associated with increased weight loss (p<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%). CONCLUSION: 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.

Intra-gastric balloon with lifestyle modification: a promising therapeutic option for overweight and obese patients with metabolic dysfunction-associated steatotic liver disease.

BACKGROUND: Data on effects of intra-gastric balloon (IGB) on metabolic dysfunction-associated steatotic liver disease (MASLD) are scarce, in part with contradictory results, and mainly obtained in tertiary care patients with diabetes and other comorbidities. We here explore effects of IGB in patients with MASLD referred to a first-line obesity clinic. METHODS: In this prospective cohort study, patients with at least significant fibrosis (≥ F2) and/or severe steatosis (S3) according to screening transient elastography (FibroScan®) were offered a second FibroScan® after 6 months lifestyle modification with or without IGB (based on patient preference). RESULTS: 50 of 100 consecutively screened patients (generally non-diabetic) qualified for repeated evaluation and 29 (58%) of those had a second FibroScan®. At baseline, at least significant fibrosis was present in 28% and severe steatosis in 91%. IGB was placed in 19 patients (59%), whereas 10 patients (41%) preferred only lifestyle modification (no differences in baseline characteristics between both groups). After 6 months, liver stiffness decreased markedly in the IGB group (median: from 6.0 to 4.9 kPa, p = 0.005), but not in the lifestyle modification only group (median: from 5.5 to 6.9 kPa, p = 0.477). Steatosis improved in both groups, (controlled attenuation parameter values; IGB, mean ± SD: from 328 ± 34 to 272 ± 62 dB/m, p = 0.006: lifestyle modification only, mean ± SD: from 344 ± 33 to 305 ± 43 dB/m: p = 0.006). CONCLUSION: Both steatosis and fibrosis improve markedly in overweight/obese patients with MASLD after 6 months IGB combined with lifestyle modification. Our results warrant further research into long-term effect of IGB in these patients.

Surgical Management of Intra-gastric Balloon Complications, Single-Center Experience, and Literature Review.

INTRODUCTION: In Saudi Arabia, the prevalence of obesity has multiplied in the last decades leading to a surge in bariatric surgery and other endoscopic modalities. The intra-gastric balloon (IGB) is the most used endoscopic modality. Surgical management for IGB complications is required for gastrointestinal perforation and/or obstruction. However, the literature seems to underestimate these complications. MATERIALS AND METHODS: A retrospective descriptive study was conducted in King Fahd University Hospital, Saudi Arabia, from Jan 2017 to Dec 2021, including all patients with complicated IGB who necessitated any surgical procedure. Exclusion criteria were patients with complicated IGBs that were only managed conservatively or endoscopically. RESULTS: A total of 326 patients were admitted with different complications after bariatric procedures. Of them, six patients were referred due to IGB complications that necessitated operative intervention. All patients were young females. Three patients had gastric wall perforation, and were managed by endoscopic removal of the IGBs followed by exploratory laparotomy. One patient had an intestinal obstruction on top of a migrated IGB that was surgically removed. One patient had failed endoscopic retrieval of IGB and required a laparoscopic gastrostomy. Another patient had an esophageal rupture that required left thoracotomy, pleural flap, and insertion of an esophageal stent. All cases were discharged and followed up with no related complications. CONCLUSION: IGB is an endoscopic alternative, within specific indications, for the management of obesity. However, surgical management may be necessary to manage its complications, including gastrointestinal perforation, IGB migration, and failure of endoscopic removal.

Clinical outcomes of single-stage versus two-stage laparoscopic Roux-en-y gastric bypass in the management of obesity (BMI ≥ 50 kg/m2): a retrospective cohort study.

BACKGROUND: Laparoscopic Roux-en-Y gastric bypass (LRYGB) in patients with obesity, BMI ≥ 50 kg/m2, can be a challenging operation. Weight loss with intra-gastric balloon (IGB) insertion prior to LRYGB may improve operative outcomes. METHODS: Between June 2000 and June 2020, patients with a BMI ≥ 50 kg/m2 underwent either IGB insertion followed by LRYGB (two-stage group), or LRYGB as the definitive bariatric procedure (single-stage group) in our institution. The two-stage procedure was adopted for high risk individuals. Primary outcome measures were percentage total weight loss (%TWL) at 24 months, length of stay and postoperative morbidity. Propensity score analysis was used to account for differences between groups. RESULTS: A total of 155 (mean age 42.9 years ± 10.60; mean BMI 54.6 kg/m2 ± 4.53) underwent either the two-stage (n = 30) or single-stage procedure (n = 125) depending on preoperative fitness. At 6 months following LRYGB, there was a significant difference in %TWL between the groups in a matched analysis (11.9% vs 23.7%, p < 0.001). At 24 months, there was no difference in %TWL (32.0% vs 34.7%, p = 0.13). Median hospital stay following LRYGB was 2.0 (1-4) days with the two-stage vs 2.0 (0-14) days for the single-stage approach (p = 0.75). There was also no significant difference in complication rates (p = 0.058) between the two groups. CONCLUSIONS: There was no difference in weight loss after one or two-stage procedures in the treatment of patients with a BMI ≥ 50 kg/m2 super obesity in a propensity score weighted analysis at 24 months. Length of stay and perioperative complications were similar for high risk patients; however, the two-stage approach was associated with delayed weight loss. Single-stage management is recommended for moderate risk patients, particularly with significant metabolic disorders, whilst two-stage approach is a safe and feasible pathway for high risk individuals.

Short term clinical efficacy of intra-gastric balloon on obesity patients with different body mass index / 中华消化外科杂志

Objective:To investigate the short term clinical efficacy of intra-gastric balloon (IGB) on obesity patients with different body mass index (BMI).Methods:The retrospective and descriptive study was conducted. The clinical data of 62 obesity patients with different BMI who were admitted to three medical centers, including 56 cases in the Hurstville Private Hospital, 4 cases in the St George Private Hospital of University of New South Wales and 2 cases in the East Sydney Private Hospital, from January 2017 to December 2021 were collected. There were 15 males and 47 females, aged 45.1(range, 18.0 to 67.0)years, with the BMI of 35.1(range, 27.8 to 48.4)kg/m 2. Of the 62 patients, there were 33 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 29 cases with BMI≥35 kg/m 2. Observation indicators: (1) first operation and postoperative complications; (2) follow-up after first IGB; (3) recurrent IGB and postoperative complications; (4) follow up after recurrent IGB. Follow-up was conducted using outpatient examinations to detect postoperative complications and weight loss effects. Patients were followed up at postoperative 1, 3, 6 month. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were represented as M (range). Count data were described as absolute numbers. Results:(1) First opera-tion and postoperative complications. All 62 obesity patients underwent the first IGB successfully. Of the 62 patients, 45 cases had postoperative complications, including 38 cases with gastroesophageal reflux, 12 cases with dysphagia or burping, 9 cases with epigastric pain and 4 cases with nausea. One patient may have multiple complications. Cases with above complications in the 33 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 29 cases with BMI≥35 kg/m 2 were 21, 8, 7, 2 and 17, 4, 2, 2, respectively. (2) Follow-up after first IGB. Of the 62 obesity patients, there were 52, 46 and 38 cases completing followed up at postoperative 1, 3 and 6 month, respectively, including 30, 25,20 cases in patients with 27 kg/m 2≤BMI<35 kg/m 2 and 22, 21, 18 cases in patients with BMI≥35 kg/m 2. Of the 62 obesity patients, there were 15 cases requiring early balloon extraction due to intractable symptoms, inclu-ding 7 cases with ongoing dysphagia or burping, 6 cases with complaining of ineffective weight loss, 1 case with acute right-sided abdominal pain and 1 case with a serendipitous discovery of pregnant. The cumulative weight loss of the 30 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 22 cases with BMI≥35 kg/m 2 at postoperative 1 month was (4.8±3.0)kg and (6.6±2.8)kg, respectively. The above indicator was (6.7±4.4)kg and (10.6±4.8)kg at postoperative 3 month for the 25 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 21 cases with BMI≥35 kg/m 2, and (8.5±4.8)kg and (9.8±3.9)kg at postoperative 6 month for the 20 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 18 cases with BMI≥35 kg/m 2. The percentage of excess weight loss was 53%±26% and 29%±15% at postoperative 6 month and the percentage of total weight loss was 14%±5% and 10%±5% at postoperative 6 month for the 20 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 18 cases with BMI≥35 kg/m 2, respectively. (3) Recurrent IGB and postoperative complications. Of the 38 cases completing the postoperative 6 month followed up after the first IGB, 9 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 7 cases with BMI≥35 kg/m 2 choosing a second IGB immediately after the removal of the first balloon. Cases with postoperative compli-cations, including gastroesophageal reflux, dysphagia or burping, epigastric pain, nausea were 4, 3, 0, 0 in patients with 27 kg/m 2≤BMI<35 kg/m 2 and 4, 0, 2, 1 in patients with BMI≥35 kg/m 2. (4) Follow up after recurrent IGB. All the 16 patients who chosen a second IGB completed the postoperative 6 month followed up, with the cumulative weight loss of (8.8±8.5)kg and (18.9±9.7)kg and the percentage of excess weight loss of 44%±38% and 41%±15% in the 9 cases with 27 kg/m 2≤BMI<35 kg/m 2 and 7 cases with BMI≥35 kg/m 2, respectively. Conclusions:IGB can achieve a good short-term weight loss effects in obesity patients with BMI≥27 kg/m 2. Gastroesophageal reflux, dysphagia or burping, epigastric pain and nausea are common postoperative complications.

Acute pancreatitis as a late complication of intra-gastric balloon insertion.

Intra-gastric balloon (IGB) insertion is a safe, well-tolerated and an effective weight loss procedure. It is commonly used as a step prior to bariatric surgery in obese patients with co-morbidities and failed conservative weight-loss methods. The main side effects post-IGB placement include nausea, vomiting and abdominal pain. The reported complications of IGB include balloon over-inflation, balloon migration, esophagitis, ulceration, gastric perforation and bowel obstruction. We report a case of acute pancreatitis attributed to IGB placement, which is a rare complication of this procedure. The diagnosis of acute pancreatitis due to IGB was made after excluding other causes of acute pancreatitis by radiological imaging. The patient underwent endoscopic IGB removal with rapid post-surgical improvement of her clinical course.

Efficacy of Liraglutide to Prevent Weight Regain After Retrieval of an Adjustable Intra-gastric Balloon-a Case-Matched Study.

PURPOSE: Weight regain after balloon retrieval is a concern with all intra-gastric balloons (IGBs). The aim of this study was to evaluate the efficacy of liraglutide, a glucagon-like peptide-1 (GLP-1) agonist, to prevent weight regain following IGB retrieval. MATERIALS AND METHODS: This was a case-matched study of patients undergoing Spatz3 adjustable IGB (Spatz FGIA, Inc. NY, USA) at three outpatient clinics in Brazil between November 2015 and January 2019. Seventy-seven patients that opted to take liraglutide following IGB retrieval (IGB-L) were matched 1:1 to 198 patients that declined the medication-IGB-Alone (IGB-A). Propensity score adjustment was performed at the time of balloon retrieval on factors known to influence the choice of liraglutide. Weight and percent body fat (%BF) was measured at baseline and 9 months after IGB retrieval. % BF is defined as the total mass of fat divided by total body mass, multiplied by 100. The primary outcome was weight regain, and the secondary outcome was change in %BF 9 months after IGB retrieval. RESULTS: Propensity score matching yielded 53 matched pairs. Weight regain to the starting point was not observed in either group. There was significantly less weight regain in IGB-L compared to IGB-A, - 1.15 ± 0.94 kg versus - 0.66 ± 0.99 kg (p = 0.010) 9 months after balloon retrieval. Additionally, %BF decline in IGB-L was superior to IGB-A - 10.83 ± 1.50 versus - 7.94 ± 2.02 (p < 0.01). There was no difference in weight regain or decline in %BF based on liraglutide dose. CONCLUSION: Liraglutide has an additive benefit with respect to efficacy and a reduction in body fat when commenced after IGB retrieval. Future randomized control studies will be needed to determine the optimal dose and duration of liraglutide to achieve superior outcomes.

Routine Intra-gastric Balloon Insertion in the Management of 'Super-Super-Obese' Patients: an Obituary?

PURPOSE: To prospectively evaluate the feasibility of single-stage bariatric surgery in patients with super-super obesity and compare their outcomes with patients undergoing intra-gastric balloon insertion as a bridging device prior to definitive surgery. MATERIALS AND METHODS: Data from 42 patients with BMI 60-75 kg/m2 who underwent either intra-gastric balloon insertion followed by sleeve gastrectomy (two-stage group); or attempted bariatric surgery as a single-stage procedure were compared. RESULTS: All patients in the single-stage group underwent successful bariatric surgery. Length of hospital stay after definitive bariatric surgery (3.3 ± 1.9 vs 2.2 ± 0.6 days, p = 0.005) and overall complication rates were significantly higher in the two-stage group. CONCLUSIONS: Routine use of an intra-gastric balloon in super-super obese patients is not required and may be associated with poorer peri-operative outcomes and delayed weight loss.

The Effect of the Intra-gastric Balloon on Gastric Emptying and the DeMeester Score.

BACKGROUND AND AIMS: The mechanism of weight loss with the intra-gastric balloon (IGB) is thought to be a decrease in gastric emptying (GE); however the evidence is conflicting. Nausea, abdominal pain, and gastroesophageal reflux disease (GERD) can cause intolerance resulting in early removal. This is demoralizing for the patient and costly for the healthcare system. The ability to predict which patients will have superior weight loss and tolerance is invaluable. We sought to investigate if the IGB induced weight loss by reducing GE and the effect of the IGB on the DeMeester score. METHODS: We retrospectively reviewed prospectively collected data for patients undergoing IGB placement at a single hospital. Manometry and pH studies were performed before and with the IGB in place. Weight was measured at baseline, at removal, and 6 months later. Adverse events leading to early removal were recorded. RESULTS: Twenty-four patients were evaluated. There was a statistically significant decrease in GE for solids with the IGB (117.92 ± 150.23 vs 281.48 ± 206.49 min; p = 0.0048), but not for liquids (54.44 ± 17.97 vs 56.08 ± 43.96 min; p = 0.7228). The lower esophageal sphincter (LES) pressure did not change significantly with placement of the IGB (17.76 ± 7.39 vs 14.74 ± 7.24 mmHg; p = 0.09). On multivariate analysis, increase in DeMeester score was associated with total body weight loss (p = 0.0125) and change in GE (p = 0.038) independently. CONCLUSION: The IGB delays GE for solids, but not for liquids, and increases the DeMeester score by a mechanism other than a loss of LES pressure.

Improving Nausea and Vomiting Post-Elipse Balloon: a Novel Single-Dose Regimen of 300 mg Netupitant/0.5 mg Palonosetron Hydrochloride.

BACKGROUND: Post intragastric balloon placement symptoms like nausea and vomiting have been the major cause of a high rate of early removal. Common therapy with ondansetron alone, or in combination, with prokinetic agents have been shown to have very little or no effect. Recently, an improved therapy based on aprepitant and ondansetron combination showed a significant improvement in symptoms management. Lack of aprepitant availability in several countries and patients difficulties to follow the right prescription convinced us to explore other pharmacological options. OBJECTIVE: Evaluate safety and efficacy of a netupitant and palonosetron-combined drug and to reduce and control post Elipse® placement symptoms METHODS: Between January and March 2018, 30 patients (9 male, 21 female), (mean weight 97.8 and mean BMI 34.7), underwent Elispe® placements, at 550 ml volume, in an outpatient fashion. All patients received a single pill 300 mg netupitant/0.5 mg palonosetron 6 h prior to placement. All patients received ondansetron 4 mg prescription to be taken as needed. A daily VAS score to report intensity of nausea, vomit, cramps, gastric pain, satiety for the first week post-placement was completed. RESULTS: 4/30 (13%) reported vomiting on days 1, 2, and 3; 9/30 (30%) reported nausea higher than score 4 on days 1, 2, and 3; 8/30 (26.6%) reported gastric pain higher than score 4 on days 1, 2, and 3. CONCLUSION: In our experience, the use of a single-pill netupitant/palonosetron resulted to be very easy to administer and effective in reducing vomit, nausea, and gastric pain in 87%, 70%, and 73.4% patients respectively, ameliorating the post Elipse™ placements symptoms safely.

Effectiveness of Intra-Gastric Balloon as a Bridge to Definitive Surgery in the Super Obese.

BACKGROUND: British National guidelines (NICE) recommend bariatric surgery for patients with a body mass index (BMI) > 40 kg/m2, or BMI > 35 kg/m2 with any comorbidities of the metabolic syndrome. Intra-gastric balloons (IGB) can be used in super obese patients as a first step, before definitive surgery. AIMS: Quantify weight loss 6 months after IGB placement, measure progression to definitive surgery and identify complications. METHODS: Data collected retrospectively on 50 patients. Forty-six proposed for definitive bariatric surgery, four patients excluded. Analysis performed using SPSS v23.0. RESULTS: Median weight decreased from 165.5 to 155 kg (range 78 to 212, p < 0.01), BMI from 57.4 to 52.15 (range 32.9 to 70.5, p < 0.01), percentage excess weight loss (%EWL) was 12.9% (range - 3.3 to 64.66%, p < 0.01) and BMI reduction was 4.25 kg/m2 (range - 1.3 to 13.9, p < 0.01). Twenty-nine out of 46 patients (63%) progressed to definitive bariatric surgery. Ten out of 46 patients (21.7%) had complications requiring readmission. Seven of these patients required early balloon removal and six failed to progress to definitive surgery. Six patients had a second balloon placement, their actual weight loss was less successful, with some regaining weight. DISCUSSION: IGB is useful to aid weight loss prior to definitive bariatric surgery. Results from first balloon placement are encouraging and comparable with other studies "as reported by Genco et al. (Int J of Obes 30:129-133, 2006)." Readmission due to nausea, vomiting, dehydration and poor compliance may be associated with poor weight loss and failure to progress to definitive surgery. Second balloon placements were less successful. CONCLUSION: IGB as bridging therapy is a safe and useful adjunct. Sequential IGBs do not seem to provide additional benefit.

Quality of life of obese patients after treatment with the insertion of intra-gastric balloon versus Atkins diet in Sulaimani Governorate, Kurdistan Region, Iraq.

BACKGROUND: Health-related quality of life of obese patients, before and after weight loss by insertion of BioEnterics Intra-gastric Balloon is studied widely. But the quality of life not related to comorbidity of the obese patients like mood, satisfaction with relationships, achieved goals, self-concepts, and self-perceived ability to cope with one's daily life is not studied on a wide scale. AIM: To evaluates the effect of the obesity on different aspects of life, and to evaluate the influence of weight loss after BIB insertion or Atkins diet on the quality of life regarding mood, satisfaction with relationships, achieved goals, self-concepts, and self-perceived ability to cope with one's daily life. PATIENTS MATERIALS AND METHODS: A prospective randomized study, from a total of 180 patients, 80 patients were selected to enroll in the work, over a period of 4 years from 2008 to 2012 in Hatwan private hospital and the private clinic, the closing date was 1st January 2013.Approval for the current work was obtained from the Ethics Committee of University, College of Medicine. The work has been reported in line with the STROCSS criteria. The study was designed as a descriptive longitudinal study conducted on 40 patients who underwent intra-gastric balloon insertion compared to a matched group (for age, BMI) of 40 patients on Atkin's diet. RESULTS: Two comparable groups of obese patients were studied, each group consists of 40 female patients, mean age in group A was 27 years (20-39 years) with mean body weight 90 kg (80-100) and mean body mass index 36 (31-39.9) who were treated with insertion of BIB. While mean age in group B was 29 years (20-39 years) with mean body weight 91 kg (80-102) and mean body mass index 36.5 (31-39.9). Statistically important changes occurred in the quality of life of the patients after either method of treatments to different degrees (p-value 0.005917). CONCLUSION: The patients lost more weight after insertion of intra-gastric balloon up to 35 kg of body weight, while the patients on Atkins diet lost up to 20 kg body weight. This results in statistically significant improvement of most aspects of QOL. Especially in Feeling happier, more satisfaction with the new body image, Improvement of self-esteem, encouraged for more regular exercises, less nervous, embarrassed less by unimportant matters, have less negative thoughts, and the craving of foods decreased remarkably.

Efficacy and Safety of Intra-gastric Balloon Placement in Dialyzed Patients Awaiting Kidney Transplantation.

BACKGROUND: The number of obese patients who are candidates for renal transplantation has considerably increased, but obesity can be a barrier to kidney transplantation. Weight loss is often difficult through diet alone. We studied the efficacy and tolerance of the intra-gastric balloon (IGB) procedure in obese patients who were undergoing dialysis and were candidates for a renal transplantation. PATIENTS AND METHODS: Obese patients (BMI > 30 kg/m2) who were candidates for renal transplantation were prospectively included in the study between 2010 and 2012. The balloon was inserted and removed during a gastric endoscopy under general anesthesia. The treatment lasted 6 months. The end point was a decrease in BMI after 6 months. Body impedance spectrometry (BIS) and nutritional statute were evaluated initially and then after IGB removal. RESULTS: Seventeen patients (nine females and eight males) with a mean age of 53.4 years [19.4-69.4] were included. The decrease in body mass index (BMI) during the 6-month placement was 3 kg/m2 (from 37.7 to 34.4 kg/m2). The mean weight loss was 7 kg. The mean percentage of excess weight loss after 6 months was 20.2 (± 11.4). The tolerance was good without any complications. Eleven patients underwent kidney transplantation. CONCLUSION: IGB in obese dialyzed patients who are candidates for renal transplantation is safe and effective. However, the amount of weight loss can vary.

Intragastric balloon therapy leads to normalization of brain magnetic resonance spectroscopic markers of diabetes in morbidly obese patients.

Elevated brain myo-inositol (m-Ins) concentration (a putative marker of neuroinflammation) has been reported in patients suffering from type 2 diabetes mellitus (T2DM). Obesity alone and T2DM have been found to be associated with a lower concentration of N-acetyloaspartate and N-acetylaspartylglutamate (tNAA, a marker of neuronal integrity, reflecting neuronal loss or metabolic derangement). It is not clear if these changes reverse with weight loss. The intra-gastric balloon (IGB) is an endoscopic bariatric therapy that leads to massive weight loss and improvement of glycemic control. In this study we evaluated if tNAA/tCr and m-Ins/tCr metabolite ratios are affected by weight loss, where tCr is the signal of creatine containing compounds. Twenty-three morbidly obese patients, 12 of them with T2DM (OD) and 11 without T2DM (OB), as well as 11 healthy controls of normal weight (CON), underwent single voxel spectroscopy at 3 T. Spectra were obtained within a region in the left parietal white matter one month before IGB insertion, three months after IGB insertion, and one month after IGB removal. Before IGB insertion, m-Ins/tCr was 15% higher in OD than in OB (p = 0.005) and 12% higher in OD than in CON (p = 0.03). m-Ins/tCr decreased significantly by 8% over the first three months after IGB insertion (p = 0.01) and remained normal after IGB removal. tNAA/tCr was normal in all groups throughout the study, pointing to normal brain metabolism. Normalization of m-Ins/tCr is consistent with remission of neuroinflammation in patients with T2DM. An evaluation of long-term effects of IGB treatment is necessary.

Mechanical intestinal obstruction caused by displacement of a stomach balloon - case report.

Methods of treating obesity in selected cases include endoscopically performed procedures, among them endoscopically placed intragastric balloons. It is a method associated with a low complication rate, traditionally reserved to treat the most obese patients. Balloon rupture or deflation and its migration into the small bowel is one of the possible complications. In some cases, the balloon moves through the digestive tract without side effects. When the balloon's displacement in the intestine is impossible, gastrointestinal obstruction occurs. We report a case of a patient with a mechanical obstruction of the gastrointestinal tract caused by asymptomatic balloon rupture and its migration into the jejunum.

Efficacy of First-Time Intragastric Balloon in Weight Loss: a Systematic Review and Meta-analysis of Randomized Controlled Trials.

BACKGROUND: The intragastric balloon (IGB) is an adjunctive treatment for obesity. This meta-analysis aimed to evaluate the efficacy and safety of IGB treatment by reviewing randomized controlled trials (RCTs). METHODS: A total of 20 RCTs involving 1195 patients were identified. Weight loss results before and after 3 months were analyzed separately. The weight loss results of patients with and without IGB treatment were compared. RESULTS: Our meta-analysis calculated the following significant effect sizes: 1.59 and 1.34 kg/m2 for overall and 3-month BMI loss, respectively; 14.25 and 11.16 % for overall and >3-month percentage of excess weight loss, respectively; 4.6 and 4.77 kg for overall and 3-month weight loss, respectively; and 2.81, 1.62, and 4.09 % for overall, 3-month, and >3-month percent of weight loss, respectively. A significant effect size was calculated that favored fluid-filled IGBs over air-filled IGBs. Flatulence (8.75 vs. 3.89 %, p = 0.0006), abdominal fullness (6.32 vs. 0.55 %, p = 0.001), abdominal pain (13.86 vs. 7.2 %, p = 0.0001), abdominal discomfort (4.37 vs. 0.55 %, p = 0.006), and gastric ulcer (12.5 vs. 1.2 %, p < 0.0001) were significantly more prevalent among IGB patients than among non-IGB control patients. No mortality was reported from IGB treatment. CONCLUSION: IGB treatment, in addition to lifestyle modification, is an effective short-term modality for weight loss. However, there is not sufficient evidence confirming its safety or long-term efficacy.