Intragastric Balloon: A Large Brazilian Multicentric Study Over 10,000 Cases and 20 Years of Experience
Bruno Queiroz Sander1*, Marina Queiroz Sander1, Dyker Santos Paiva1, Jimi Izaques Biffi Scarparo4, Giorgio Alfredo Pedroso Baretta5, Manoel Galvao Neto6, Eduardo Grecco7, Joao Antonio Schemberk Jr8, Joao Caetano Dallegrave Marchesini9, Thiago Ferreira de Souza10, Gabriel Caio Nunes11 and Luiz Ronaldo Alberti12
1Endoscopist Surgeon, Federal University of Minas Gerais, Brazil
2Medical in Sander Medical Center, Brazil
3General surgeon, Member of the Brazilian Society of Bariatric and Metabolic Surgery, Brazil
4Clinical Director of SCARPARO, Clinic Scopia Day Hospital, Brazil
5Positivo University, Surgeon and Endoscopist of Vita Batel Hospital in Curitiba, Brazil
6Department of Surgery, Florida International University, Brazil
7Faculty of Medicine of ABC, EndoVitta Institute Bariatric Endoscopist, Brazil
8Digestive and Endoscopic Surgeon, Brazil
9General Director of the Marchesini Clinic, Federal University of Paraná, Brazil
10ABC Medical School, Doctor of Medicine, Brazil
11Nutritionist at SCARPARO Clinic Scopia Day Hospital, Brazil
12Medical School at Universidade Federal de Minas Gerais, Brazil
Submission: December 01, 2018; Published: February 13 , 2019
*Corresponding author: Bruno Queiroz Sander, Endoscopist Surgeon, Federal University of Minas Gerais, Sander Medical Center, Av. Bernardo Monteiro, 1265 - Funcionários, Belo Horizonte - MG, 30150-285, Brasil
How to cite this article: Bruno Q S, Marina Q S, Dyker S P, Jimi I B S, Giorgio A P B, et al. Intragastric Balloon: A Large Brazilian Multicentric Study Over
002 10,000 Cases and 20 Years of Experience. Adv Res Gastroentero Hepatol. 2019; 12(3): 555839. DOI: 10.19080/ARGH.2019.12.555839.
Introduction: Obesity is a global disease and its management includes pharmacological therapy, non-absorptive surgery and intragastric balloon (IGB). The IGB has been used for more than 20 years in Brazil as an endoscopic method to aid in weight loss. Thus, the objective of this work was to describe the results of this procedure in IGB in Brazil.
Methods: This prospective study had a total of 10,255 patients submitted to IGB between 1997 and 2017. Patients with IGB filled with a fluid volume of between 620 and 700 ml, and a minimum initial BMI of 27 kg/m2 were inserted non-study. The maximum follow-up time was nine months.
Results: This is a specific motion (31.1 years), mostly women (78%). The mean BMI weight was: 33.42 ± 6.62 kg/m2, mean final BMI: 27.16 ± 8.42 kg/m2, p <0.01. The incidence of complications with IGB was 0.03% (n=3): gastric perforation. A total of 5.2% of the patients followed up for 18 months after a withdrawal of the IGB was submitted to bariatric surgery.
Conclusion: IGB is a safe and effective technique for weight loss, with complication rates. With the assistance of a multidisciplinary team, the results were satisfactory.
Obesity is a persistent health problem in many lives, making it a challenge in medicine with a large concentration of studies.That is, it should be a great part of the metabolic repercussions and contraceptive outcomes with this comorbidity, with the increase rate of morbimortality rates with repercussions on the impact indices on patients’ quality of life and also on the economy [1-4].
The obesity, which has many types of treatment, that may appear listed in set, depending of each case. Among the treatments found there are changes in patients’ lifestyle, minimally invasive
treatments and even different types of surgeries. The minimally
invasive treatments for obesity, an intragastric (IGB) treatment
technique, has been shown to be a promising procedure, since
there are several projects with good results with significant
weight and low complications. This is relevant a vapor note the
high rates of failure of riots and the style of life, in addition to the
admittedly known invasive treatments [5-8].
Thus, the objective of this study was to analyze the results of
the six specialized centers in the treatment of obesity, using the
minimally invasive procedures of the IGB, describing the clinical
outcomes and their complications.
This work was approved by the Research Ethics Committee
under the CAAE protocol: 42995915.4.0000.5132. Seven centers
specialized in the treatment of obesity, with wide experience
in IGB participated in this study. For the standardization of the
data, a model of filling of the data was elaborated in the Excel
program, that after compiling all the data, these were sent for
statistical analysis. All patients submitted to the IGB procedure
between January and 1997 to December 2017 participated in this
study. Among the inclusion criteria are: A liquid filled IGB with
a volume between 620 to 700 ml and patients with a minimum
BMI of 27kg / m².
Statistical analysis was performed using SPSS-IBM software
(version 13.0). All data analyzed according to their distribution of normality. Statistical analysis was performed according to sex
and degree of excess weight (overweight and grade I, II and III).
Data were analyzed using Student t-test, and Tukey post-test.
The level of significance was set at p <0.05.
In the period determined by the study, 10255 procedures
were performed. Of this total of procedures, 4.8% (n = 492) were
excluded from the analysis of clinical outcomes of weight loss
due to early withdrawal of IGB (Table 1). However, therapeutic
failure of this study was lower than that observed in the study by
Neto et al. . Analysis of this group of excluded patients showed
that 94% of them did not undergo a psychological evaluation
before the procedure and 88% did not perform nutritional
monitoring during the use of the IGB. This data reveals once again
the importance of a multidisciplinary team in the treatment and
follow-up of patients with IGB. Not just during, since treatment
is temporary, and the multidisciplinary team builds long-term
behavioral changes that will lessen the chances of regaining
weight after IGB withdrawal.
The percentage PEP was higher in the overweight group
(129.92% PEP), followed by obese I (73.64%), II (57.85%)
and III (41.33%) sequentially. A total of 5.2% (66/1 268) of
the patients followed up for 18 months after withdrawal of the
IGB was submitted to bariatric surgery. Among the observed
complications were spontaneous hyperinflation in 0.99% (n =
101) and spontaneous deflation or leakage in 0.82% (n = 84). Kim
et al.  in their review observed that spontaneous deflation
occurs in approximately 6% of patients, a rate much higher than that observed in the present study. With increasing advances in
biomaterials, the newer balloons have a greater gastric capacity
and are filled with saline, producing fewer adverse effects, which
may explain in part the low deflation of this study.
The epidemiological profile is a young population with a
mean age of 31.1 years, mostly women (78%, n = 7,615). This
profile is similar to that described in several papers [5,6,10-15].
Clinical outcomes related to therapeutic success (Figure 1), show that there was a significant weight loss, with significantly lower
final BMI (27.16 ± 8.42 kg/m2; variation: 15.71-34) than the
baseline BMI (33.42 ± 6.62 kg/m2, range: 27 to 79.35). The mean
weight loss was -16.98 kg (+/- 16.8 kg). The primary endpoint of
therapeutic success in our study was a mean reduction of BMI of
6.26 kg / m² and an average weight loss of 16 kg, data similar to
that found by Neto et al. .
The incidence of complications that did not lead to removal
was 6.65% (n = 682). Other complications occurred as fungal
contamination in 7.9% (n = 810); Wernick Korsakoff syndrome
0.01% (n = 2), gestation during the implant period was 1.2% (n
= 123) and the Dieulafoy lesion 0.01% (n = 1). The incidence
of complications with IGB removal was 0.03% (n = 3): gastric
perforation. Não houve nenhum caso de mortalidade nesse
The observed data corroborate the international literature
[5-8,12-19], showing that the technique is safe, effective and with
low complication rates. The multidisciplinary team is important
in conducting treatment for therapeutic success. Further
study evaluating the variables involved in the complications
is necessary in order to provide a more adequate selection of
whistleblowers to this procedure.
Ashrafian H, Monnich M, Braby TS, Smellie J, Bonanomi G, et al. (2018) Intragastric balloon outcomes in super-obesity: a 16-year city center hospital series. Surgery for obesity and related diseases: official journal of the American Society for Bariatric Surgery 14(11): 1691-1699.
Ribeiro da Silva J, Proenca L, Rodrigues A, Pinho R, Ponte A, et al. (2018) Intragastric Balloon for Obesity Treatment: Safety, Tolerance, and Efficacy. GE Portuguese journal of gastroenterology 25(5): 236-242.
Sullivan S, Swain J, Woodman G (2018) Randomized sham-controlled trial of the 6-month swallowable gas-filled intragastric balloon system for weight loss. Surgery for obesity and related diseases: official journal of the American Society for Bariatric Surgery 14(12): 1876-1889.
Nguyen V, Li J, Gan J (2017) Outcomes following Serial Intragastric Balloon Therapy for Obesity and Nonalcoholic Fatty Liver Disease in a Single Centre. Canadian journal of gastroenterology & hepatology 4697194.