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From 1SOM Clinic, Gastroenterology – Quito, Equador; 2Universidad de las Américas, Faculty of Health Sciences – Quito, Equador; 3Universidade de São Paulo
– São Paulo (SP), Brazil.
How to cite this article: Jerez J, Cabrera D, Cisneros C, Moreno M, Guaitara D, Benavides C, et al. Intragastric balloon and impact on weight loss: experience in Quito,
Equador. ABCD Arq Bras Cir Dig. 2023;36:e1731. https://doi.org/10.1590/0102-672020230002e1731
ABSTRACT – BACKGROUND: Obesity is associated with dierent medical conditions, such as
cardiologic, respiratory, gastrointestinal, and genitourinary, and constitutes a severe health problem.
AIMS: This study aimed to evaluate the use of intragastric uid-lled balloon in the reduction of
weight and other measurements related to body composition. METHODS: This is a retrospective,
monocentric study involving all patients who opted for the intragastric balloon Spatz® placement
from January 2018 to July 2019, with fulllment of inclusion and exclusion criteria. The patients were
analyzed after 6 and 12 months after the intragastric uid-lled balloon placed. RESULTS: A total of
121 subjects were included in this study, with 83 (68.6%) females and 38 (31.4%) males. The mean age
was 36 years and height was 1.64±0.09. Weight mean and standard deviation was 89.85±14.65 kg,
and body mass index was 33.05±4.03; body mass index decreased to 29.4 kg/m2 with a mean weight
of 79.83 kg, after 12 months of follow-up. There were statistical dierences between body mass
index and the 12 months in fat percentage, fat-free mass (kg), visceral fat area, and basal metabolic
rate. There was a signicant variation according to gender, with males having highest reduction.
The percentage of excess weight loss was 46.19, and the total weight loss was 9.24 at the end of
the study. CONCLUSIONS: The study demonstrated a benet of intragastric uid-lled balloon on
weight loss after 12 months. At the end of treatment, body mass index and the measurements of
body composition were signicantly lower. Men beneted more than women from the treatment.
HEADINGS: Endoscopy. Body mass index. Digestive system. Body weight. Obesity.
Original Article
INTRAGASTRIC BALLOON AND IMPACT ON WEIGHT LOSS: EXPERIENCE
IN QUITO, EQUADOR
BALÃO INTRAGÁSTRICO E IMPACTO NA PERDA DE PESO: EXPERIÊNCIA EM QUITO, EQUADOR
Jonathan JEREZ1 , David CABRERA1 , Carlos CISNEROS1 , Monica MORENO1 , Daniela GUAITARA1 ,
Chiristian BENAVIDES1 , Martha FORS2 , Kirsten FALCON3
Financial source: None
Conicts of interest: None
Received: 01/16/2022
Accepted: 01/30/2023
Correspondence:
Kirsten Falcon.
E-mail: kirstenfalcon@hotmail.com
ABCD Arq Bras Cir Dig
2023;36:e1731
https://doi.org/10.1590/0102-672020230002e1731
RESUMO – RACIONAL: A obesidade está associada a diferentes condições médicas,tais como
cardiológicas, respiratórias, gastrointestinais, geniturinárias entre outras e constituem um grave
problema de saúde. OBJETIVOS: Avaliar o emprêgo do balão intragástrico na redução de peso
e em outras medidas relacionadas à composição corporal. MÉTODOS: Estudo retrospectivo,
monocêntrico, incluindo todos os pacientes que optaram pela colocação de balão intragástrico
Spatz® entre janeiro de 2018 e julho de 2019, com cumprimento dos critérios de inclusão e exclusão.
RESULTADOS: Cento e vinte e um indivíduos foram recrutados neste estudo. A média de idade
foi de 36 anos e estatura de 1,64±0,09, sendo 83 (68,6%) do sexo feminino e 38 (31,4%) do sexo
masculino. A média do peso e o desvio padrão foram de 89,85±14,65 kg e o índice de massa corporal
foi de 33,05±4,03. Após 12 meses, o índice de massa corporal diminuiu para 29,4 kg/m2 com um
peso médio de 79,83 kg. Foram registradas diferenças estatísticas no índice de massa corporal,
no percentual de gordura, massa livre de gordura (kg), área de gordura visceral e taxa metabólica
basal. Houve variação signicativa de acordo com o sexo, sendo o masculino com maior redução.
O porcentual de perda de excesso de peso foi de 46,19% e de perda de peso total de 9,24 %ao
nal do estudo. CONCLUSÕES: O estudo demonstrou benefícios do balão intragástrico na perda de
peso após 12 meses de colocação do balão. Ao nal do tratamento, o índice de massa corporal e
as medidas de composição corporal foram signicativamente menores. Os homens se beneciaram
mais do que as mulheres do tratamento.
DESCRITORES: Endoscopia. Índice de Massa Corporal. Sistema Digestório. Peso Corporal. Obesidade.
Trabalho realizado no 1Serviço de Cirurgia Geral e Aparelho Digestivo, Departamento de Clínica Cirúrgica, Faculdade de Medicina, Universidade Federal de Goiás, Goiânia, GO,
Brasil; 2Serviço de Endoscopia, Hospital das Clínicas e Departamento de Gastroenterologia, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brasil;
3Serviço de
Cirurgia do Fígado, Hospital das Clínicas e Departamento de Gastroenterologia, Faculdade de Medicina, Universidade de São Paulo, São Paulo, SP, Brasil
Como citar esse artigo: de Biase Silva-Neto WB, Quirese C, De Moura EGH, Coelho FF, Herman P. A queda da pressão portal após desvascularização esofagogástrica e esplenectomia
/10.1590/0102-672020210001e1581
A QUEDA DA PRESSÃO PORTAL APÓS DESVASCULARIZAÇÃO
ESOFAGOGÁSTRICA E ESPLENECTOMIA INFLUENCIA A VARIAÇÃO
DO CALIBRE DAS VARIZES E AS TAXAS DE RESSANGRAMENTO NA
ESQUISTOSSOMOSE NO SEGUIMENTO EM LONGO PRAZO?
Does the drop in portal pressure after esophagogastric devascularization and splenectomy
variation of variceal calibers and the rebleeding rates in schistosomiasis in late follow-up?
Walter de Biase SILVA-NETO1, Claudemiro QUIRESE1, Eduardo Guimarães Horneaux de MOURA2,
Fabricio Ferreira COELHO3, Paulo HERMAN3
Recebido para publicação: 17/09/2020
Aceito para publicação: 14/12/2020
Correspondência:
Walter De Biase da Silva Neto
E-mail: wbiase123@gmail.com;
biase@terra.com.br
www.instagram.com/abcdrevista www.facebook.com/abcdrevista www.twitter.com/abcdrevista
ABSTRACT - Background: The treatment of choice for patients with schistosomiasis with
previous episode of varices is bleeding esophagogastric devascularization and splenectomy
(EGDS) in association with postoperative endoscopic therapy. However, studies have shown
varices recurrence especially after long-term follow-up. Aim: To assess the impact on
behavior of esophageal varices and bleeding recurrence after post-operative endoscopic
treatment of patients submitted to EGDS. Methods: Thirty-six patients submitted to EGDS
portal pressure drop, more or less than 30%, and compared with the behavior of esophageal
varices and the rate of bleeding recurrence. Results
late post-operative varices caliber when compared the pre-operative data was observed
despite an increase in diameter during follow-up that was controlled by endoscopic therapy.
Conclusion
variceal calibers when comparing pre-operative and early or late post-operative diameters.
The comparison between the portal pressure drop and the rebleeding rates was also not
HEADINGS: Schistosomiasis mansoni. Portal hypertension. Surgery. Portal pressure.
Esophageal and gastric varices.
RESUMO - Racional: O tratamento de escolha para pacientes com hipertensão portal
esquistossomótica com sangramento de varizes é a desconexão ázigo-portal mais
esplenectomia (DAPE) associada à terapia endoscópica. Porém, estudos mostram aumento
do calibre das varizes em alguns pacientes durante o seguimento em longo prazo. Objetivo:
Avaliar o impacto da DAPE e tratamento endoscópico pós-operatório no comportamento
das varizes esofágicas e recidiva hemorrágica, de pacientes esquistossomóticos. Métodos:
Foram estudados 36 pacientes com seguimento superior a cinco anos, distribuídos em
dois grupos: queda da pressão portal abaixo de 30% e acima de 30% comparados com o
calibre das varizes esofágicas no pós-operatório precoce e tardio além do índice de recidiva
hemorrágica. Resultados
esofágicas que, durante o seguimento aumentaram de calibre e foram controladas com
o comportamento do calibre das varizes no pós-operatório precoce nem tardio nem os
índices de recidiva hemorrágica. Conclusão
operatórios precoces ou tardios. A comparação entre a queda de pressão do portal e as
DESCRITORES: Esquistossomose mansoni. Hipertensão portal. Cirurgia. Pressão na veia porta. Varizes esofágicas
e gástricas.
1/4
ABCD Arq Bras Cir Dig 2021;34(2):e1581
Perspectiva
Este estudo avaliou o impacto tardio no índice
de ressangramento de pacientes submetidos ao
tratamento cirúrgico e endoscópico. A queda na
variação do calibre das varizes quando comparado
o seu diâmetro no pré e pós-operatório precoce e
tardio. A comparação entre a queda de pressão
portal e as taxas de ressangramento, também
evidenciar se apenas a terapia endoscópica, ou
operações menos complexas poderão controlar o
sangramento das varizes.
Evolução do calibre das varizes no período pré e pós-
operatório precoce e tardio
Mensagem central
A desconexão ázigo-portal e esplenectomia
apresenta importante impacto na diminuição
precoce do calibre das varizes esofágicas na
esquistossomose; entretanto, parece que a
associação com a terapia endoscópica é a maior
responsável pelo controle da recidiva hemorrágica.
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Editorial Support: National Council for Scientic and Technological Development (CNPq).
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ABCD Arq Bras Cir Dig 2023;36:e1731
Perspectives
The study demonstrated a benet of intragastric
uid-lled balloon on weight loss after 12 months.
At the end of treatment, body mass index and
the measurements of body composition were
signicantly lower. Men beneted more than
women from the treatment.
Central Message
The intragastric balloon is a reversible,
endoscopically placed device approved for
limited-term use in overweight and obese
patients. The use of intragastric balloon
treatment is a good alternative, as it is safer and
has lower costs, and may be indicated in patients
with mild obesity (BMI=30 kg/m2). Some studies
have shown moderate weight loss of 15 kg or
more with the use of the intragastric balloon.
Statistical analysis
Qualitative variables are presented as proportions and
percentages and continuous variables as mean and standard
deviation. The normal distribution of continuous variables was
explored using the Shapiro-Wilk test and found that most of
them were non-normally distributed.
For body composition variables, statistical differences
between gender were calculated with Mann-Whitney U test.
Changes of body composition variables were calculated by each
variable at last visit (12 months) minus variables at baseline.
Comparisons among means of continuous variables were
made using Friedman test and non-parametric alternative
to the one-way ANOVA with repeated measures when data
are non-normal. Post-hoc Dunn’s test was performed. The
significance was set at 0.05 (p<0.05). Mann-Whitney U test
was used to compare the means of 2 independent samples,
and the Wilcoxon test to compare the means of paired
samples. Paired t-tests were used to compare mean of
angle phase at 6 and 12 months. The relationship between
body composition indexes and gender was analyzed using
Pearson’s chi-square test. Spearman’s correlation coefficient
was used to determine the correlations between variations
in weight and body composition parameters. The data
were analyzed by SPSS (version 24.0; SPSS Inc., Chicago,
Illinois, USA).
Ethical aspects
The participants were informed about the purpose of the
procedure. They rst read over and sign a consent form informing
them of their rights and the benets and risks associated with
the placement of intragastric balloon. All procedures performed
were in accordance with the ethical standards of the institutional
and with Helsinki Declaration. This report followed STROBE
guidelines for observational studies. The study was approved
by Ethics Committee SOM-2017-003.
RESULTS
A total number of 121 patients were selected for analysis,
with 83 (68.6%) females and 38 (31.4%) males. Patients had
a mean age of 36 years and height of 1.6 m±1 cm. Weight
mean and standard deviation was 89.8±14.6 kg, and the BMI
was 33.0±4.0 at pretreatment. At the end of the treatment,
the BMI decreased to 29.4 kg/m2 with a mean weight of 79.8
kg. Compared to baseline values, the patients experienced
signicant reductions in weight, BMI, fat-free mass (FFM) (kg),
basal metabolic rate (BMR) (kcal), visceral fat area (VFA), and
phase angle (p<0.00) (Table 1).
The dierences between pretreatment (baseline) values
and after the periods of follow-up (final) are displayed in
(Figure 1 A-F).
The post-hoc comparison with Dunn’s test showed
a significant mean difference in indicators, before the IGB
placement and after 6 and 12 months. In addition, a non-
signicant statistical dierence is found between 6 and 12
months (Table 2).
Average weight loss in the male group was 14.7±20.7 kg,
which was higher than that in the female group. After 6–12
months of follow-up, our patients showed a mean BMI of 3.4 kg
in men and 3.1 kg in women, but we could not demonstrate a
signicant dierence between gender. A statistically signicant
dierence was observed only in BW, MME, FFM, and phase
angle. Values in men were higher (Table 3).
The mean percentage of total weight loss (TWL) achieved
was 9.24±5.71 at 6 months and 9.37±6.51 at 12 months (non-
signicant dierence: p=0.73, p>0.05). The mean percentage
INTRODUCTION
Overweight and obesity remain a big public health
issue, affecting over one-third of the world’s
population today25. According to the World Health
Organization (WHO), obesity is “a condition in which percentage
body fat (PBF) is increased to an extent in which health and
well-being are impaired”, and, due to the alarming prevalence
increase, it was declared as a “global epidemic”27.
In 2016, 1.3 billion adults were overweight worldwide and
the number of adults with obesity increased by sixfold from
100 to 671 million (69–390 million women and 31–281 million
men) between 1975 and 201624. One of the main challenges in
addressing overweight and obesity lies in adopting a common
public health measure of these conditions28. As a result, body
mass index (BMI) is adopted as an indicator for defining
overweight and obesity23,35.
In Ecuador, according to data published in the National
Health and Nutrition Survey Ecuador (ENSANUT-ECU 2011–2013)22,
the prevalence of overweight and obesity at a national level in
people older than 19 years is approximately 62.8%, with rate
being greater in women (65.5%) than in men (60%).
Currently, there are many treatments available for adults
with overweight and obesity, including reduced calorie diet,
exercises, behavior modication, and use of specic treatments;
however, some of these approaches do not achieve very
good results. The intragastric balloon (IGB) is a reversible,
endoscopically placed device approved for limited-term use
in overweight and obese patients. Since bariatric surgery is of
high cost, with complication risks and invasiveness, the use of
IGB treatment is a good alternative as it is safer and of lower
costs. Some studies have shown moderate weight loss of 15
kg or more with the use of the IGB21,30,36.
This technique has been the most frequently used in
practice and the most studied for this medical condition and
may be performed in patients with mild obesity (BMI=30
kg/m2). Body weight loss achieved with intragastric balloon
placement is associated with improvements in obesity-related
metabolic illness18. Its placement also aects hunger control
and gastric emptying through alterations in gut hormones
and peptides7.
A meta-analysis showed that endoscopic obesity treatment
could be eective and of substantial value if combined with a
multidisciplinary and comprehensive treatment plan5.
The objective of this study was to contribute to the
experience in the country in the evaluation of the use of IGB
for achieving weight loss and its impact on body composition
measurements.
METHODS
This is a retrospective, monocentric study, which included
all patients who opted for the intragastric balloon Spatz®
placement from January 2018 to July 2019, with fulllment of
inclusion and exclusion criteria.
The inclusion criteria for this study were as follows: patients
who opted for the Spatz® intragastric balloon whose clinical
history contained complete data for 12 months in the period
between January 2018 and July 2019. A total of 121 patients
were selected. Patients who do not complete 12 months of
treatments were excluded.
The patients were analyzed after 6 and 12 months of the
IGB placement, based on the parameters such as body weight
(kg), BMI (kg/m2), musculoskeletal mass, percentage fat mass
(%), fat-free mass (kg), basal metabolic rate (kcal), visceral fat
area (cm2). and phase angle (°).
ORIGINAL ARTICLE
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INTRAGASTRIC BALLOON AND WEIGHT LOSS
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Table 1 - Results of 12 months of intragastric uid-lled balloon treatment (n=121)
Characteristics
Average
(mean±SD)
Average
(mean±SD)
Average
(mean±SD) p-value*
pretreatment 6 months 12 months
Body weight (kg) 89.8±14.6 81.4 ±13.4 79.8±16.0 <0.00
BMI (kg/m2)33.0±4.0 29.8±3.3 29.8±3.5 <0.00
Musculoskeletal mass 28.9±7.0 27.4±6.7 27.4 ±6.7 0.22
Percentage fat mass (%) 42.3±6.7 39.2±7.5 39.0±7.7 <0.00
Fat-free mass (kg) 37.8±7.9 31.9±7.9 31.9±7.9 <0.00
Basal metabolic rate (kcal) 1491.1±249.7 1447.8±241.4 1441.6±239.0 <0.00
Visceral fat area (cm2)181.3±205.2 180.7±38.9 154.6±43.9 0.02
Phase angle (°) 5.5±0.8 –5.6±0.7 <0.00**
*Friedman test; **Student’s t-test (normally distributed variable). BMI: body mass index; SD: standard deviation; IGB: intragastric uid-lled balloon
Figure 1A - Baseline and nal weight (kg).
Final weight (kg).
BMI: body mass index. Baseline BMI (kg/m2)
Figure 1B - Baseline and nal BMI (kg/m2).
BMI: body mass index. Final BMI (kg/m2).
Figure 1C - Baseline and nal percentage fat mass (%).
of excess weight loss (EWL) was 46.19±38.51 at 6 months and
45.28±38.43 at 12 months (p=0.72, p>0.05). We did not nd
any statistical dierences between gender in these indicators
in any of the two times (Table 4).
Regarding weight loss results, a generally accepted
criterion to know if the method is successful is if percentage
of TWL is >7% and percentage of EWL is >30%. According to
this criterion, we compared percentage of EWL at two times.
The proportions of patients having successful weight loss
(TWL>7%) were 64.0% (n=78) at 6 months and 62.0% (75)
at 12 months. The proportions of patients having successful
weight loss (EWL>30%) were 62 and 62.8% at 6 and 12 months,
respectively. There was a statistically signicant dierence in
both cases. A statistically meaningful linear correlation between
a 6-month EWL and TWL and a 12-month EWL or TWL was
found (Table 5).
ORIGINAL ARTICLE
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Final fat-free mass (kg).
Figure 1D - Baseline and nal fat-free mass (kg).
Final basal metabolic rate (kcal)
Figure 1E - Baseline and nal basal metabolic rate (kcal).
Final visceral fat area (cm2).
Figure 1F - Baseline and nal visceral fat area (cm2).
Baseline Visceral fat area (cm2).
DISCUSSION
This is the rst study to document outcomes with the use
of IGB therapy in Ecuador. In the current study, 6 months of
treatment with IGB was associated with improvements in the
indicators measured. At the end of 12 months term, signicant
reductions were seen in both weight and BMI for most of the cohort.
Some studies have reported on the ecacy of IGB in inducing
signicant weight loss over the short to medium period16,26,29.
In our study, mean weight loss 12 months after balloon
placement was 14.71±20.71 in men and 7.87±6.19 in women.
At the end of the IGB treatment period, it showed signicant
weight loss. Many authors have reported gures ranging from
9.5 to 20.1 kg13,14,20,31,32.
INTRAGASTRIC BALLOON AND WEIGHT LOSS
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ABCD Arq Bras Cir Dig 2023;36:e1731
Table 2. - Post-hoc analysis of mean dierences.
*Dunn’s post-hoc analysis. BMI: body mass index.
Time points Mean dierences p-value* 95% Condence interval
Lower bound Upper bound
Weight
Pretreatment 6 months 8.4 0.00 3.8 12.9
12 months 10.0 0.00 5.4 14.5
6 months 12 months 1.5 1.00 -2.9 6.1
BMI
Pretreatment 6 months 3.46 0.00 2.25 4.67
12 months 3.20 0.00 1.99 4.41
6 months 12 months 0.25 1.00 -0.95 1.47
Percentage fat mass (%)
Pretreatment 6 months 3.16 0.00 0.88 5.45
12 months 3.32 0.00 1.03 5.60
6 months 12 months 0.15 1.00 -2.12 2.44
Fat-free mass (kg)
Pretreatment 6 months 5.93 0.00 3.47 8.39
12 months 6.23 0.00 3.77 8.69
6 months 12 months 0.30 1.00 -2.15 2.76
Visceral fat area (cm2)
Pretreatment 6 months -45.38 0.02 -85.77 -5.00
12 months -23.12 0.50 -63.50 17.26
6 months 12 months 22.26 0.55 -18.12 62.65
Table 3 - Mean dierences according to sex of patients at 12 months of balloon placement.
*Mann-Whitney U test. BMI: body mass index; SD: standard deviation.
Mean dierences
Male
n=38
(mean ± SD)
Female
n=83
(mean ± SD)
p-value*
Body weight (kg) 14.7±20.7 7.8±6.1 0.03
BMI (kg/m2)3.4±2.1 3.1±2.4 0.39
Musculoskeletal mass 1.7±1.5 1.3±1.3 0.05
Percentage fat mass (%) 4.3±3.7 2.8±2.9 0.05
Fat-free mass (kg) 7.3±5.3 5.7± 4.5 0.15
Visceral fat area (cm2)10.8±70.2 28.7±84.0 0.17
Phase angle (°) 6.3±0.8 5.3±0.4 0.00
Table 4 - Means of percentage of total weight loss and percentage of excess weight loss according to gender, at 6 and 12
months follow-up.
*Mann-Whitney U test.
Mean
(%)
6 months p-value 12 months p-value*
Male Female Male Female
TWL 10.54±6.385 8.64±5.31 0.09 10.41±6.41 8.89±6.54 0.23
EWL 54.25±40.34 42.0±0.37 0.12 43.71±39.64 43.78±39.64 0.50
After 6–12 months of follow-up, our patients showed a
mean weight loss of 8.25 kg, similar to other studies evaluating
IGB8-10. In the current study, statistically signicant dierences
were observed between gender. Al-Sabah et al., for example,
did not report signicant variation in the weight loss according
to this variable3.
Some studies reported that there was a signicant reduction
of visceral fat area6,34, while other authors reported that the
visceral fat area showed no signicant decrease33.
Sekino et al.33 also reported that preoperative intragastric
balloon therapy may produce a favorable reduction of the
visceral fat area and that the use of IGB for a few weeks may
serve as a useful preparation procedure prior to laparoscopic
bariatric surgery. We found that initial value of VFA decreased
along the period of study.
Our results show a signicant decrease in percentage
of fat mass and free fat mass, while Donadio et al.11 found
a reduction in percentage of fat mass (-19.5%), but not in
fat-free mass.
Regarding FFM, our study demonstrated that men had a
reduction of 7% and women 5%, without statistical dierences
between them. In a study performed in Poland, there was a
5.4% reduction in FFM15. Folini et al.12 also reported a decrease
in FFM and percentage of fat mass. Another study reported a
decrease in FFM at 6–12 months31.
These results were better observed in our patients between
pretreatment and 6 months, where the reduction of these
indicators was higher. Their means were not dierent between
6 and 12 months.
The overall TWL and EWL were 9.37±6.51% and 45.28±38.43%
at 12 months, respectively. In the current study, approximately
60% of the individuals had very good results at 6 and at 12
months in both indicators, taking into account the criteria of
Abu et al.1.
Agnihotri et al.2 found a higher percentage of TWL at
12 months (14.7±11.8%) and reported that 60.4% of patients
achieved more than 10% of TBWL and 55.4% had more than
25% of EWL. Even in a dierent cuto point, our results are
found very similar.
Al-Subaie et al.4 reported %TBWL of 10.44% and EWL
(%) 40.84%, which are very similar to our results. According to
Lewis et al.19, a 10% loss in body weight (10%TWL) will translate
into a reduction of visceral, central, and abdominal fat, as well
as the size of the liver.
Excess weight loss of 38.5% was the results for the
study by Al-Sabah et al.3, which is lower than the values in the
current study, while Guedes et al.17 reported percentage of
EWL of 56.04±4.90, which is higher than ours. Al-Sabah et al.3
also found statistically signicant dierences between gender
regarding percentage of EWL, while we did not35.
CONCLUSION
The study demonstrated a benet of intragastric uid-
lled balloon on weight loss after 12 months. At the end of
treatment, BMI and the measurements of body composition
were signicantly lower. Men beneted more than women
from the treatment.
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Table 5 - Dierences between 6 months and nal measurements
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*χ²; **Pearson’s correlation coecient.
6 months 12 months p-value*
No. % No. %
TWL (%)
TWL>7% 78 64.5 75 62.0 0.00
TWL<7% 43 35.5 46 38.0
EWL (%)
EWL>30% 75 62.0 76 62.8 0.00
EWL<30% 46 38.0 45 37.2
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