Mide Balonu (İntragastrik Balon) İle İlgili Makaleler
1: Obes Surg. 2008 Dec 10. Efficacy, Tolerance and Safety of New Intragastric Air-Filled Balloon (Heliosphere BAG) for Obesity: the Experience of 17 Cases.Trande P, Mussetto A, Mirante VG, De Martinis E, Olivetti G, Conigliaro RL, De Micheli EA.
Internal Medicine and Gastroenterology Unit, New S’Agostino Hospital, Modena, Italy.
BACKGROUND: Overweight and obesity lead to serious health consequences, so that many strategies were recommended for preventing or curing this emerging problem. Treatments are various: diet, physical activity, psychotherapy, drugs, and bariatric surgery. Moreover, during these years, the use of intragastric balloon (BIB) to treat obesity increased rapidly, aimed to (1) reduce bariatric surgical risks; (2) reduce general surgical risks; (3) lead to a significant reduction in the prevalence of cardiovascular diseases, diabetes, musculoskeletal disorders and some cancers. Recently, a new device inflated with air to reduce weight has been developed since 2004 (Heliosphere BAG). METHODS: Between March 2006 and September 2006, in our unit, intragastric air-filled balloon insertion was performed under general anesthesia and endoscopic control. The balloons were removed after 6 months. We evaluated efficacy, tolerance, and safety of this technique. Seventeen patients (eight men, nine women), with a mean age of 43 +/- 10 years (range 18-65), mean basal BMI of 46 +/- 8 (range 35-58) were included, after providing informed consent. Weight and BMI loss were evaluated in all patients. RESULTS: BMI decreased 4 +/- 3 (range +0.33/-11), weight loss was 11 +/- 9 kg (range +1/-29.5; 8.5%). 14/17 patients maintain a BMI > 35 at the time of balloon removal. The difference between initial weight and BMI was statistically significant (p = 0.02 for weight and p < 0.01 for BMI, T Student test). Tolerance was very good, limited only to some dyspeptic symptoms during the first 3 days after insertion. One asymptomatic gastric ulcer was seen at the removal of balloon. Only one severe adverse effect was registered at the time of insertion (acute coronary syndrome in patient with chronic coronary disease). No serious technical problems were noted at balloon insertion. Balloon removal was more difficult and successful in 15/17 cases (one distal migration and one patient led to surgery because of balloon fragmentation). CONCLUSION: Intragastric air-filled balloon showed a good profile of efficacy and tolerance. Weight loss appeared to be equivalent to other type of balloons. On the other hand, technical problems (especially at the time of removal) probably linked to the device's material, set a low safety profile.
2: Obes Surg. 2008 Dec;18(12):1611-7. Epub 2008 Jun 21Evidence-based Review of the Bioenterics Intragastric Balloon for Weight Loss.Dumonceau JM.
We reviewed clinical studies performed with the Bioenterics intragastric balloon (BIB) to promote weight loss. Thirty studies were included [18 prospective (5 randomized), 12 retrospective], totaling 4,877 patients. Only one of three sham-controlled trials found a significantly higher weight loss with the BIB vs the sham procedure plus exhaustive follow-up. In nonrandomized studies, weight loss with the BIB averaged 17.8 kg (range, 4.9-28.5), corresponding to BMI changes of 4.0-9.0 kg/m(2). Comorbidities resolved or improved in 52-100% of patients. Best short-term results were observed in patients devoid of binge eating disorder with a BMI in the 30.0-40.0 kg/m(2) range; the BIB also helped to prepare superobese patients for bariatric surgery. Severe complications were exceptional (gastric perforation and intestinal obstruction; 0.2% each); digestive intolerance prompted early BIB removal in 2.5% of patients. Long-term (>/=2 years) results are awaited, as well as well-designed studies to define the best indications for this therapy.
3: Obes Surg. 2008 Nov 18.Impact on Obesity-Related Illnesses and Quality of Life Following Intragastric Balloon.Mui WL, Ng EK, Tsung BY, Lam CH, Yung MY.
BACKGROUND: The impact of intragastric balloon (IGB) on obesity-related illnesses and quality of life (QOL) has not been previously investigated. METHOD: One hundred and nineteen consecutive obese patients (86 females; mean age 37.8; mean body weight (BW) 103.7 +/- 24.1 kg; mean BMI 38.4 +/- 8.0 kg/m(2)) who underwent IGB were evaluated for improvement on obesity-related illnesses and QOL after weight reduction in a multidisciplinary university referral center. Bioenterics Intragastric balloon (BIB(R)) system was employed in the study. RESULTS: Mean treatment period was 169.9 +/- 34.8 days. Mean BW, BMI, and excess body weight loss were 12.4 +/- 6.9 kg, 4.6 +/- 2.7 kg/m(2), and 45.1 +/- 35.3%. Mean waist circumference and biceps fold and triceps fold loss were 10.5 +/- 8.3, 9.8 +/- 8.5, and 8.7 +/- 7.4 cm respectively. Metabolic syndrome was decreased from 42.9% to 15.1% after IGB (p < 0.0005). Improvement of obesity-related illnesses were significant in fasting glucose, cholesterol, triglyceride, C-reactive protein, and blood pressure (p < 0.005).In 28 diabetes patients, HBA1C level was significantly decreased as compared to baseline (7.4 vs. 5.8%; p < 0.0005). The QOL of patients was significantly improved after IGB (p < 0.05). No serious complication related to IGB was observed. Four patients (3.3%) had intolerence and required early removal of balloon. Thirty-one patients (26%) received further bariatric surgery after IGB. CONCLUSIONS: IGB produces meaningful weight loss and significantly improves obesity-related illnesses and quality of life.
4: Obes Surg. 2008 Nov;18(11):1443-9. Epub 2008 May 1BioEnterics intragastric balloon for treatment of morbid obesity in Prader-Willi syndrome: specific risks and benefits.De Peppo F, Di Giorgio G, Germani M, Ceriati E, Marchetti P, Galli C, Ubertini MG, Spera S, Ferrante G, Cuttini M,Cappa M, Castelli Gattinara G, Rivosecchi M, Crinò A.
Paediatric Surgery Unit, Bambino Gesù Children’s Hospital-Research Institute, Palidoro (Roma), Italy.
BACKGROUND: Obesity in Prader-Willi Syndrome (PWS) is progressive, severe, and resistant to dietary, pharmacological, and behavioral treatment. A body weight reduction is mandatory to reduce the risk of cardio-respiratory and metabolic complications. The aim of the study was to assess risks and benefits of BioEnterics Intragastric Balloon (BIB) for treatment of morbid obesity in PWS patients. METHODS: Twenty-one BIB were positioned in 12 PWS patients (4 M, 8 F), aged from 8.1 to 30.1 years, and removed after 8 +/- 1.4 months (range: 5-10 months). Auxological, clinical, and nutritional evaluations were performed every 2 months. Variations in body composition were analysed by dual energy X-ray absorbiometry (DXA). RESULTS: One patient (28.5 years, BMI: 59.3 kg/m(2)) died 22 days after BIB positioning because of gastric perforation. In another case (26.2 years, BMI: 57.6 kg/m(2)), BIB was surgically removed after 25 days because of symptoms suggesting gastric perforation (not confirmed). The remaining ten patients showed a significant decrease of BMI (p = 0.005) and of fat tissue as measured by DXA (p = 0.012). No significant modifications in bone mineral density (BMD) occurred, but a slight loss in lean body mass (p = 0.036) was documented. In five patients, BIB treatment was repeated more than once. CONCLUSION: This study shows that when noninvasive pharmacological therapies fail, BIB may be effective to control body weight in PWS patients with morbid obesity, particularly when treatment is started in early childhood. However, careful clinical follow-up and close collaboration with parents are crucial to avoid severe complications, which can be caused by persisting unrestrained food intake.
5: Obes Surg. 2008 Nov;18(11):1438-42. Epub 2008 Mar 28Bariatric therapy with intragastric balloon improves liver dysfunction and insulin resistance in obese patients.Ricci G, Bersani G, Rossi A, Pigò F, De Fabritiis G, Alvisi V.
BACKGROUND: Obesity is often associated with fatty liver (FL). In most cases, bright liver at ultrasound (US) and increased alanine aminotransferase (ALT) and gamma-glutamyltranspeptidase (GGT) levels are considered the hallmarks of nonalcoholic fatty liver disease (NAFLD). Insulin resistance (IR) is the main link between obesity and NAFLD. The use of the Bioenterics intragastric balloon (BIB) is a safe procedure either for inducing a sustained weight loss with diet support or for preparing those patients who are candidates for bariatric surgery. The aim of the study was to investigate whether the weight loss induced by intragastric balloon might improve IR and liver enzymes. The presence or absence of FL at US and the influence of a body mass index (BMI) decrease > or = 10% after BIB (DeltaBMI > or = 10%) were also considered. METHODS: One hundred and three consecutive obese (BMI > 30 kg/m(2)) patients (38 males/65 females; mean age 41.3, range 20-63 years) underwent BIB insertion under endoscopic control. The BIB was removed 6 months later. US, clinical, and routine laboratory investigations were performed before and after BIB. IR was calculated by the homeostasis model assessment (HOMA-IR > 2.5). Exclusion criteria were hepatitis B virus positive, hepatitis C virus positive, alcohol consumption >30 g/day, history of hepato-steatogenic drugs, and type 1 diabetes. RESULTS: Ninety-three patients were eligible for the study. The BMI significantly decreased in all investigated patients, and it was > or = 10% in 59% of the patients. FL was seen at US in 70%, impaired fasting blood glucose was present in 13%, ALT exceeded the normal limit in 30.1%, GGT exceeded the normal limit in 15%, and HOMA-IR was >2.5 in 85%. Median HOMA-IR decreased significantly in FL (4.71 vs 3.10; p < 0.05) and non-FL (3.72 vs 2.81; p < 0.01) groups. Median ALT decreased significantly in the FL group (31.5 vs 24; p < 0.001) and GGT significantly decreased in the FL group (31 vs 23.5; p or = 10%, the median values of HOMA-IR (4.95 vs 2.69; p < 0.05), ALT (30 vs 23; p < 0.01), and GGT (28 vs 20; p < 0.001) significantly decreased after BIB. In the non-FL group, HOMA-IR values significantly decreased (4.07 vs 2.36; p or = 10%; ALT and GGT did not significantly decrease. CONCLUSIONS: Weight loss induced by intragrastric balloon reduces IR. The ALT and GGT decrease suggests an improvement in hepatic damage. The benefit depends on the decrease of BMI higher than 10%.
6: Obes Surg. 2008 Oct 22. Changes in Quality of Life After Balloon Treatment Followed by Gastric Banding in Severely Obese Patients-The Use of Two Different Quality of Life Questionnaires.Rutten SJ, de Goederen-van der Meij S, Pierik RG, Mathus-Vliegen EM.
BACKGROUND: Improvements in quality of life (QOL) obtained by weight loss have mainly been reported after bariatric surgery. QOL has not been investigated in surgical patients first losing weight by nonsurgical means followed by a surgical intervention and never simultaneously by two QOL-a generic and a disease-specific-questionnaires. METHODS: Prospective data were obtained from 40 consecutive patients (mean age 36.6 years, body weight 142.4 kg, body mass index (BMI) 46.5 kg/m(2)). Two different QOL questionnaires, the generic Medical Outcomes Study Short Form-36 (SF-36) and the disease-specific Health-Related Quality of Life (HRQL) questionnaire, were evaluated at three points in time: at the start, 3 months after the placement of an intragastric balloon that remained in situ for 6 months, and 3 months after subsequent gastric banding. RESULTS: QOL scores revealed a significant improvement in many health domains, with an earlier improvement with the disease-specific HRQL, whereas the generic QOL questionnaire lagged behind. However, in the end, the SF-36 caught up completely to normal-weight levels, whereas some scales of the HRQL remained below these levels. Work productivity and involvement in sports improved significantly. BMI declined significantly over time, but no correlation with SF-36 and HRQL score changes was found. CONCLUSION: The QOL improved substantially independent of changes in BMI. Because of the divergent outcomes of generic and disease-specific QOL questionnaires, prospective studies should examine the sensitivity to changes of both kinds of QOL questionnaires.
7: Obes Surg. 2008 Oct 9.Concomitant Laparoscopic Adjustable Gastric Banding and Laparoscopic Cholecystectomy in a Super-Obese Patient with Situs Inversus Totalis Who Previously Underwent Intragastric Balloon Placement.Taskin M, Zengin K, Ozben V.
Laparoscopic adjustable gastric banding has been increasingly performed since its introduction in 1990. Situs inversus totalis is a rare anomaly in which transposition of organs to the opposite side of the body occurs. Laparoscopic gastric banding in such few patients has been reported in the literature. We discuss a super-obese patient with situs inversus totalis and asymptomatic cholelithiasis who previously underwent endoscopic intragastric balloon placement in preparation for bariatric surgery. Afterwards, laparoscopic cholecystectomy and laparoscopic adjustable gastric banding were performed in the same session. Special attention is paid to the literature review and the mirror-image modification of the laparoscopic cholecystectomy and laparoscopic gastric banding procedures. With preoperative assessment, modifications in the surgical team, and equipment, the operation can be performed safely.
8: Obes Surg. 2008 Oct 2.Gastric Perforation and Death after the Insertion of an Intragastric Balloon.Koutelidakis I, Dragoumis D, Papaziogas B, Patsas A, Katsougianopoulos A, Atmatzidis S, Atmatzidis K.
G.Gennimatas Hospital, 2nd Surgical Clinic, Aristotle University of Thessaloniki, Ethnikis Aminis, 41, P. O. Box 54635, Thessaloniki, Greece.
We report a case of a patient who presented with an acute abdomen 2 days after the insertion of an intragastric balloon system and discuss in detail the advantages and drawbacks of these devices in the therapy of morbid obesity. A 43-year-old morbidly obese man was admitted to the department of surgery in shock with a 2-h history of severe diffuse abdominal pain and the initial diagnosis of visceral perforation. The patient had been subjected to intragastric placement of an inflatable balloon 48 h prior to his presentation. Abdominal exploration revealed the presence of a large linear perforation in the fundus of the stomach.
1: Obes Surg. 2008 Sep;18(9):1154-6. Epub 2008 Jun 3 BioEnterics intragastric balloon: clinical outcomes of the first 100 patients–a Turkish experience.Coskun H, Bostanci O, Dilege E, Bozbora A.
BACKGROUND: The BioEnterics Intragrastric Balloon (BIB) together with restricted diet has been used for the treatment of obesity and morbid obesity. METHODS: A prospective study was conducted on 100 patients who had undergone the BIB procedure between February 2005 and February 2007. RESULTS: Mean age, mean weight, and mean BMI of the patients were 35.35 +/- 9.25 years, 113.23 +/- 24.76 kg (range 73-200 kg), and 39.28 +/- 6.98 kg/m(2) (range 30-69.2 kg/m(2)), respectively. Six months after the BIB procedure, mean weight and mean BMI were reduced to 100.46 +/- 26.05 kg (range 58-178 kg) and 34.70 +/- 11 kg/m(2) (range 21.83-61.59 kg/m(2)), respectively. There was a statistically significant reduction in weight and BMI at 6 months after the BIB procedure (p < 0.01). Excess weight loss (EWL) at 6 months ranged between 0 and 28 kg, with a mean value of 12.68 +/- 7.70 kg. The subjects had 0 to 99.2% %EWL (mean 28.63 +/- 19.29). Reduction in BMI at 6 months ranged between 0 and 12.3 kg/m(2), with a mean value of 4.51 +/- 2.85 kg/m(2), and percent excess body mass index loss (%EBMIL) was 38.20 +/- 28.78% (range 0-158%). At 6 months, there was a significant reduction in body weight and BMI (p < 0.01) in both groups. The reduction in BMI of the morbidly obese group was significantly greater than that of the obese group (p = 0.035), and both the %EWL and %EBMIL of the morbidly obese patients were significantly lower than those of the obese patients at 6 months (p = 0.001). CONCLUSIONS: BIB application is a reasonable weight loss method with few complications.
1: Obes Surg. 2008 Aug 28. Bio-enteric Intragastric Balloon in Obese Patients: A Retrospective Analysis of King Faisal Specialist Hospital Experience.Al Kahtani K, Khan MQ, Helmy A, Al Ashgar H, Rezeig M, Al Quaiz M, Kagevi I, Al Sofayan M, Al Fadda M.
Section of Gastroenterology, Department of Medicine (MBC: 46), King Faisal Specialist Hospital and Research Centre, PO Box: 3354, Riyadh, 11211, Saudi Arabia.
BACKGROUND: Bio-enteric intragastric balloon (BIB) insertion is gaining popularity for weight reduction in obese patients. We evaluated the efficacy, tolerability, and safety of BIB in the treatment of obesity. METHODS: A total of 173 Saudi obese patients [mean+/-SD age 34.5 +/- 11.6 years, 58 (33.5%) were men] who underwent BIB (InaMed Corporation, California, USA) insertion were followed up clinically, biochemically, and endoscopically for 6-12 months. The mean+/-SD baseline body weight, excess weight, and body mass index (BMI) were 123.5 +/- 39.6 and 68.9 +/- 40.0 kg and 46.7 +/- 14.1 kg/m(2), respectively. Associated dietary control, exercise, and medical treatment were used in 67 (38.7%), 60 (34.7%), and 3 (1.7%), respectively. RESULTS: BIBs were safely and successfully inserted in 15.1 +/- 6.2 min, filled with 626.2 +/- 41.7 ml methylene blue solution, removed after a period of 189.7 +/- 68.3 days, within 14.1 +/- 6.3 min. BIB was not tolerated for 6 months in 33 (19.8%) patients. Body weight and BMI at 6 and 12 months postinsertion were significantly reduced to 112.5 +/- 35.7 kg and 43.1 +/- 13.1 kg/m(2), and 110.7 +/- 34.5 kg and 42.3 +/- 12.6 kg/m(2), respectively (p /=25% occurred in 24.1% and 30.1% of patients at 6 and 12 months postinsertion, respectively. CONCLUSION: BIB is a safe, simple, and potentially efficient procedure that is well-tolerated by the majority of patients.
1: Obes Surg. 2008 Aug 20. Assessment of the Application of the Intragastric Balloon Together with Sibutramine: A Prospective Clinical Study.Coskun H, Bostanci O.
BACKGROUND: The aim of this study is the prospective evaluation of the results of Bioenterics intragastric balloon (BIB) with sibutramine and BIB placement alone in the treatment of obesity. METHODS: The patients evaluated between March 2006 and January 2007 and enrolled in this study were assessed in two groups as group A (BIB + sibutramine) and group B (BIB). After the follow-up of the patients for 6 months, body mass index (BMI), weight loss, excess weight loss (EWL%), and excess body mass index loss (EBMIL%) values of the patients in both groups were compared. RESULTS: According to the comparison of the weights of the patients in groups A and B at 6 months with the beginning weights of the patients in both groups, there was statistically significant weight loss (p < 0.01). The total weight loss at 6 months in group A was statistically significantly higher than that in group B (p 0.05). CONCLUSION: In the management of obesity, using BIB together with sibutramine before the treatment in the patient group who are planned to have surgery, compared with using only BIB, provides more effective weight loss.
1: Obes Surg. 2008 Aug 8. Esophageal Perforation After Gastric Balloon Extraction.Ruiz D, Vranas K, Robinson DA, Salvatore L, Turner JW, Addasi T.
Department of Surgery, New York Hospital Queens, 56-45 Main Street, Flushing, New York, NY, 11355, USA.
We report a case of a 59-year-old female with esophageal perforation following endoscopic removal of an intragastric balloon. To our knowledge, this is the first case of esophageal perforation associated with intragastric balloon extraction reported in the English literature.
1: Obes Surg. 2008 Aug;18(8):989-92. Epub 2008 May 16 Intragastric balloon or diet alone? A retrospective evaluation.Genco A, Balducci S, Bacci V, Materia A, Cipriano M, Baglio G, Ribaudo MC, Maselli R, Lorenzo M, Basso N.
BACKGROUND: Very few studies have reported results of the BioEnterics Intragastric Balloon (BIB) at > or =12 months follow-up. The aim of this study is the retrospective evaluation of the results of BIB placement compared to diet regimen alone. METHODS: From January 2005 to June 2006, 130 outpatients underwent a structured diet plan with simple behavioral modification at our institutions. Controls (n = 130) were selected from the charts of patients who, during the same period, underwent BIB treatment. Patients in the outpatient group were given a structured balanced diet with a caloric intake between 1,000 and 1,200. The approximate macronutrient distribution, according the “Mediterranean diet,” was 25% protein (at least 60 g/day), 20-25% lipids, and 50-55% carbohydrates. In the BIB group, patients received generic counseling for eating behavior. In both groups, we considered weight loss parameters (kilograms, percentage of excess weight loss [%EWL], body mass index [BMI], percentage of excess BMI loss [%EBL]) at 6 and 24 months from baseline and comorbidities at baseline and after 24 months. Results are expressed as mean+/-standard deviation. Statistical analysis was done by Student’s t-test and chi (2)-test or Fisher’s exact test. p < .05 was considered significant. RESULTS: At the time of BIB removal (6 months), significantly better results in terms of weight loss in kilograms (16.7 +/- 4.7 vs. 6.6 +/- 2.6; p < 0.01), BMI (35.4 +/- 11.2 vs. 38.9 +/- 12.1; p < 0.01), %EBL (38.5 +/- 16.1 Vs 18.6 +/- 14.3; p < 0.01), and %EWL (33.9 +/- 18 vs. 24.3 +/- 17.0; p < 0.01) were observed in patients treated by intragastric balloon as compared to diet-treated patients. At 24 months from baseline, patient dropout was 1/130 (0.7%) and 25/130 (19.2%) in the BIB and diet groups, respectively (p < 0.001). At this time, patients treated with intragastric balloon have tended to regain weight, whereas diet-treated patients have already regained most of lost weight. CONCLUSIONS: Although the strength of this study may be limited by its retrospective design, the results indicate that, in the short-to-medium term, BIB is significantly superior to diet in terms of weight loss.
1: Obes Surg. 2008 Jul 10. Cardiac Arrest After Intragastric Balloon Insertion in a Super-Obese Patient.Cubattoli L, Barneschi C, Mastrocinque E, Bonucci P, Giomarelli PP.
A super-obese patient who suffered from severe sleep apnea (SSA) and other comorbidities underwent insertion of a BioEnterics intragastric balloon (BIB) before bariatric surgery. During the night, he was victim of cardiac arrest. After cardiopulmonary resuscitation and return of spontaneous circulation, he was transferred to intensive care unit. Two hours later, he developed an unexpected symptomatic bradycardia, and BIB was removed. The patient had no further cardiac complications, but he had a poor neurological outcome. In our opinion, such a severe cardiac event was the result of several causes. The BIB induces vagal nerve activation by stretching the gastric wall. In addition, super-obese patients with sleep apnea and other comorbitities have an increased risk of potentially fatal cardiac arrhythmias especially during the night. For all these reasons, we think that these patients may benefit from further preoperative cardiac investigations and a more intensive control during the first postinsertion day.