Brazilian Multicenter Study of the Intragastric Balloon

Sallet, José Afonso; Marchesini, João Batista; Paiva, Dyker; Komoto, Keila; Pizani, Carlos; Ribeiro, Maurélio L B; Miguel, Pablo; Ferraz, Álvaro Antônio Bandeira; Sallet, Paulo Clemente

doi:10.1381/0960892041719671

Cited by 167 publications

(121 citation statements)

References 25 publications

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“…How the intragastric balloon works is still unknown, although the sense of fullness and delayed gastric emptying have often been described in the literature as their chief effects. 18,20 This study shows that the BIB s treatment is a safe and effective procedure for weight reduction. The intragastric balloon can play a role for the temporary weight reduction of morbidly obese patients in diet supporting, as well as in the preoperative treatment of patient candidate for bariatric surgery or other surgical procedures (i.e.…”

Section: -15mentioning

confidence: 70%

BioEnterics® Intragastric Balloon (BIB®): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients

et al. 2005

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Background: The BioEnterics s Intragastric Balloon (BIB s ) System in association with restricted diet has been used for the shortterm treatment of morbid obesity. Aim of this study was to evaluate the real, short term, efficacy of the BIB for weight reduction in morbidly obese patients by using a prospective, double-blind, randomised, sham-controlled, crossover study. Methods: Patients were recruited from January 2003 to December 2003. After selection, they were randomly allocated into two groups: BIB followed by sham procedure after 3 months (Group A), and sham procedure followed by BIB after 3 months (Group B). All endoscopic procedures were performed under unconscious intravenous sedation. The BioEnterics Intragastric Balloon (Inamed Health; Santa Barbara, CA, USA) was filled by using saline (500 ml) and methylene blue (10 ml). Patients were discharged with omeprazole therapy and diet (1000 kcal). Patients were followed up weekly by a physician blinded to randomisation. In both groups mortality, complications, BMI, BMI reduction and %EWL were considered. Data were expressed as mean7s.d., except as otherwise indicated. Statistical analysis was performed by means of Student's t-test, Fisher's exact test or w 2 with Yates correction; Po0.05 was considered significant. Results: A total of 32 patients were selected and entered the study (8M/24F; mean age: 36.275.6 years, range 25-50 years; mean BMI 43.771.5 kg/m 2 , range 40-45 kg/m 2 ; mean %EW: 43.1713.1, range: 35-65). All patients completed the study. Mortality was absent. Complications related to endoscopy, balloon placement and removal were absent. Mean time of BIB positioning was 1572 min, range 10-20 min. After the first 3 months of the study, in Group A patients the mean BMI significantly (Po0.001) lowered from 43.571.1 to 38.072.6 kg/m 2 , while in Group B patients the decrease was not significant (from 43.671.8 to 43.172.8 kg/m 2 ). The mean %EWL was significantly higher in Group A than in Group B (34.074.8 vs 2.171%; Po0.001). After crossover, at the end of the following 3 months, the BMI lowered from 38.072.6 to 37.173.4 kg/m 2 and from 43.172.8 to 38.873.1 kg/m 2 in Groups A and B, respectively. Conclusions: The results of this study show that treatment of obese patients with BioEnterics Intragastric Balloon is a safe and effective procedure. In association with appropriate diet it is significantly effective in weight reduction when compared to sham procedure plus diet. The BIB s procedure can play a role in weight reduction in morbidly obese patients or in the preoperative treatment of bariatric patients.

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Section: -15mentioning

confidence: 70%

BioEnterics® Intragastric Balloon (BIB®): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients

et al. 2005

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“…Previously published results revealed an average weight loss of 12-15 kg over 6 months with an excellent safety profile [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16] . The Spatz Adjustable balloon was introduced in 2010 as the first IGB approved for 1 year implantation while featuring an adjustability function that afforded balloon volume changes as needed.…”

Section: Introductionmentioning

confidence: 99%

One year adjustable intragastric balloon: safety and efficacy of the Spatz3 adjustable balloons

Machytka

Brooks²,

Bužga

et al. 2014

F1000Res

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Discuss this article AbstractThe Spatz3 Adjustable balloon system is approved for 1 year Background: implantation and allows multiple changes in the balloon volume during the course of implantation. Other intragastric balloons are currently approved for 6 months and their balloon volumes cannot be adjusted after implantation.To determine the efficacy and safety of the Spatz3 adjustable balloon Aim: system.Seventy seven consecutive patients (66 females and 11 males) in Methods: two medical centers were implanted with the Spatz3 adjustable balloon device and were followed prospectively. The patients' mean BMI was 37.2; the mean weight was 108.7 kg; the mean age was 41 (16-68); the mean balloon volume was 469 ml (450-500 ml). Adjustments were made for intolerance or weight loss plateau.The mean weight loss at 1 year was 17.2 kg with 15.9 % weight loss Results: and 42.9 % Excess Weight Loss (%EWL). Eighteen patients underwent balloon volume adjustments: three downward adjustments of 100 -150 cc which alleviated early intolerance; 15 upward adjustments (mean 320 ml; range 200-500) at a mean 4.1 months (range 2-5 months) yielded additional mean wt loss of 8.2 kg (range 0-25 kg) after the adjustment. Three balloons were removed before the 1 year completion date due to intolerance and three others were removed for other reasons (pregnancy, gall bladder surgery, and alcoholism). There was one episode of gastric ulceration which required endoscopic therapy and balloon removal. There were no deflations or perforations.The Spatz3 adjustable balloon is a safe and effective treatment Conclusions: for weight loss. The adjustability function can yield greater weight loss for those who show weight loss plateau and can mitigate intolerance.

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“…In most cases the balloons spontaneously deXated and were eliminated during defecation. In several cases of balloon migration into the small intestine percutaneous puncture was necessary before anal extrusion [9,10]. One case of large bowel balloon impaction requiring laparoscopic enterotomy has been described [11].…”

Section: Discussionmentioning

confidence: 99%

Parastomal hernia incarceration due to migrated intragastric balloon

Limani

Steinemann

Clavien

et al. 2011

Hernia

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The temporary placement of intragastric balloons is a common method to achieve rapid weight loss before planned metabolic surgery. We report the case of a 48-year-old morbidly obese patient. Ten years ago the patient underwent emergency sigmoidectomy with creation of a double-barreled ileostomy for perforated diverticulitis. Over time he developed a giant parastomal hernia. For preoperative weight reduction before planned restoration of intestinal continuity, an intragastric balloon was inserted 3 years ago. The patient was admitted to our emergency department with peritonism and a septic shock. After computed tomography showing small bowel ileus, laparotomy was performed, revealing marked ischemia of incarcerated small and large intestine. Only postoperatively was the intragastric balloon found in the resected small bowel, causing a mechanical ileus with consecutive incarceration of the bowel. We review the literature on complications due to the migration of intragastric balloons. This clinical case gives a fair warning of the possible deleterious outcome of intragastric balloons, especially in hernia patients.

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Brazilian Multicenter Study of the Intragastric Balloon

Abstract: The BIB((R)) has been effective to temporarily control obesity, inducing an excess weight loss of approximately 48%. It was not associated with mortality and showed minimal risk of major complications.

Cited by 167 publications

References 25 publications

BioEnterics® Intragastric Balloon (BIB®): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients

BioEnterics® Intragastric Balloon (BIB®): a short-term, double-blind, randomised, controlled, crossover study on weight reduction in morbidly obese patients

One year adjustable intragastric balloon: safety and efficacy of the Spatz3 adjustable balloons

Parastomal hernia incarceration due to migrated intragastric balloon

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