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Usefulness and Safeness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity

Usefulness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity To Decrease Bariatric Surgery Morbidity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01998243
Enrollment
81
Registered
2013-11-28
Start date
2009-01-31
Completion date
2016-11-30
Last updated
2019-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Keywords

morbid obesity, bioenterics intragastric balloon, bariatric surgery

Brief summary

Introduction: bariatric surgery shows an important morbidity and there are some reports that have used preoperative intragastric-balloons (IGB-BIB®) to decrease surgical morbidity. Patients Methods: Since 2009 we are performing a randomized and prospective study to assess the usefulness of (IGB-BIB®) before bariatric surgery \[sleeve resection (SR) or gastric bypass (GB)\] group A. The intervention in this group was was to place an intragastric Balloon for 6 months vs a control group B with the same type of surgical procedures but without preoperative IGB-BIB.The intervention on this group was only to treat the obesity only with diet for 6 months . All patients coming for both groups were followed at 4-week intervals by a nurse practitioner and dietitian for 6 months, Nurse practitioner made the dietetics adjustments (750-1500 Kcal) , provide advice and assess the evolution of weight loss The hypothesis was that preoperative IGB-BIB helps the patients to lose weight ( more than 10%) ,and the weight loss will contribute to decrease surgical morbidity by at least 30%, and also will decrease hospital stay Objective: to check if morbidity, mortality and hospital stay decreased in the IGB-BIB ® group, and secondly if the weight before surgery was associated with surgical morbidity. secondary objective : Assess the rate of IGB-BIB failure.Intragastric balloon failure was considered when the weight loss is less than 10% from the initial weight. We defined severe complication whenever the patient had to be admitted in the hospital after discharge, new surgeries or transfusions were required or the hospital stay was longer than 7-10 days.

Detailed description

Treatment with an intragastric balloon (IGB) for morbid obesity is a temporary treatment reached as a second step, when the initial nutritional multidisciplinary approach has failed; however, its value is not clear compared with other conventional medical treatments \], though some authors have stated that IGB achieves higher weight loss than conventional diet treatments (12.2% of the initial weight) \]; and others have positioned IGB as the first valid step in order to achieve weight loss in patients who are adequate for a future gastric bypass surgery. Genco et al (2009) have compared the treatment with IGB only vs. laparoscopic sleeve gastrectomy (LSG), and have found no differences in the amount of weight loss at 6 months, but a reduction in adverse events caused by IGB treatment. One of the potential future indications for the intragastric balloon could be its use as a bridge-treatment until bariatric surgery, not only in order to achieve weight loss before surgery, but also to select the group of patients who might benefit more from derivative surgery, as suggested by some authors or its use in special populations such as super-obese patients . The objective would be to reduce weight before the surgical procedure, in order to improve comorbidities, facilitate the surgical technique, and potentially reduce any surgical complications. It is increasingly frequent in many surgical units to try and achieve weigh loss before bariatric surgery, using intragastric balloons (IGB). However, this therapeutic approach currently presents dubious utility. Our study intends to contribute with our experience in the evaluation of IGB before surgery for achieving weight loss, and its impact on post-surgical morbidity. Bariatric surgery shows an important morbidity and there are not to many randomized prospective studies using intragastric- balloons (IGB-BIB®) to evaluate if getting weight lost really matter on decreasing surgical complications before Bariatric surgery OBJECTIVE: To study the usefulness of preoperative IGB-BIB® grA \[sleeve resection (SR) or gastric bypass (GB)\] to help decrease postsurgical complications. Secondly we try to check the rate of IGB-BIB® failures (a total weight loss less than 10% of the initial weight), and the impact on decreasing hospital stay and rate of surgical reoperations. METHODS: The study was a clinical prospective and randomized essay coming from 2009. Cases (grA) had an IGB during 6 months before surgery vs Controls (grB)

Interventions

DEVICEIntragastric Balloon (IGB), group A

the intervention was to place An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM) endoscopically under conscious sedation and was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors (PPI), and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems

OTHERdiet, control group B

the intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Hospital Severo Ochoa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. \- Morbid obesity (BMI ≥ 40 kg/m2 ) with a failed Conventional Medical treatment 2. \- Morbid obesity (BMI ≥ 35 kg/m2) with important comorbidity with a failed Conventional Medical treatment 3. \- they should be operated by a laparoscopic gastric sleeve or by laparoscopic gastric by-pass

Exclusion criteria

1. \- Slight adherence to previous medical treatments . 2. \- Hiatal hernia more than 3 cms 3. \- Patients with active gastric or duodenal ulcer disease 4. \- Severe esophagitis 5. \- Psychiatric diseases (depression, bulimia etc) 6. \- Associated Severe Systemic Disease not amenable to improve with weight loss 7. \- Patients with Inflammatory bowel diseases 8. \- Patients on anticoagulant treatment or steroids . 9. \- Addiction to Drugs or alcohol 10. \- Past history of gastric surgery ,antireflux surgery or any other type of bariatric surgery 11. \- Patient refusing to be followed 6 months before and after surgery 12. \- Pregnancy or foreseeable pregnancy during the study 13. \- Patients with gastric or esophageal varices 14. \- proton pump inhibitor (PPI) allergy

Design outcomes

Primary

MeasureTime frameDescription
Postsurgical Morbidity on Both Arms of the Studywithin the 90 days after surgerypostsurgical morbidity includes all kind of post operative morbidity( mild ,moderate and severe) moderate and severe post surgical morbidity is the most important one
Total Postsurgical Morbidityduring the 6 months having the intragastric balloon and 90 days after surgerytotal postsurgical morbidity included the morbidity specifically due to the Intragastric balloon plus all the postoperative morbidity related to the surgical procedure severe intragastric balloon morbidity refers only to medical complications which meet the criteria of severe of The accordion severity grading system .

Secondary

MeasureTime frameDescription
Hospital Stay,the period of the study started when patients were randomizated and finished 90 days after surgeryall in all hospital stay
Rate of Surgical Conversion to Open Surgeryduring the initial laparoscopic surgerynumber of patients with surgical conversion from laparoscopic to open surgery
Percentage of Re-operationsduring all the period of the study ending within 90 days after surgeryPercentage of Re-operations during all the period of the study ending within 90 days after surgery

Countries

Spain

Participant flow

Recruitment details

151 patients were eligibles for the study and were evaluated at the endocrinologist office

Pre-assignment details

40 patients rejected to be included in the study and 30 were excluded before randomization for not to fulfill all the established requirement to be included

Participants by arm

ArmCount
Group B
this is the control group, It includes patients followed during at least 6 months before bariatric surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
34
Intragastrc Balloon (IGB) Group A
this is the intervention group, it includes patients who had a preoperative intragastric balloon during a period of 6 months before operation preoperative intragastric balloon ( IGB-BIB®): An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM)is placed endoscopically under conscious sedation was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors, and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
32
Total66

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPregnancy01
Overall StudyProtocol Violation52
Overall StudyWithdrawal by Subject34

Baseline characteristics

CharacteristicGroup BIntragastrc Balloon (IGB) Group ATotal
Age, Continuous42.6 years OF AGE
STANDARD_DEVIATION 9.2
43 years OF AGE
STANDARD_DEVIATION 10.2
42.8 years OF AGE
STANDARD_DEVIATION 9.6
Americam Society of Anestesiologist Physical Status Classification System (ASA) ; ASA score III;11 participants12 participants23 participants
BMI before surgery(kg/m^2)44.3 kg/m^2
STANDARD_DEVIATION 5.5
40 kg/m^2
STANDARD_DEVIATION 6.2
42.2 kg/m^2
STANDARD_DEVIATION 5.9
Ethnicity (NIH/OMB)
Hispanic or Latino
34 Participants32 Participants66 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Excess Body Mass Index Loss (EBMIL) before surgery (excess BMI loss)1 percentage of EBMI loss6.04 percentage of EBMI loss3 percentage of EBMI loss
Excess weight loss (EWL) before surgery4.54 percentage of EWL27.14 percentage of EWL11.1 percentage of EWL
ICU (hours) intensive care unit21.5 hours)11 hours)20 hours)
Operation time (hours)2.8 hours
STANDARD_DEVIATION 0.73
2.8 hours
STANDARD_DEVIATION 0.79
2.8 hours
STANDARD_DEVIATION 0.76
Percentage of Failure of Intragastric Balloon11 Participants11 Participants
Region of Enrollment
Spain
34 Participants32 Participants66 Participants
Sex: Female, Male
Female
24 Participants21 Participants45 Participants
Sex: Female, Male
Male
10 Participants11 Participants21 Participants
Starting body mass index (starting BMI)46 kg/m^2
STANDARD_DEVIATION 4.9
46.4 kg/m^2
STANDARD_DEVIATION 6.9
46.2 kg/m^2
STANDARD_DEVIATION 5.7
Starting body mass index (starting BMI) > 50 (kg/m^2)8 Participants7 Participants15 Participants
Starting weight (kg)125 Kg
STANDARD_DEVIATION 18.5
129.2 Kg
STANDARD_DEVIATION 19.4
127.1 Kg
STANDARD_DEVIATION 18.9
Surgery (sleeve resection (LSG)or gastric bypass (LGBP)
LGBP
23 Participants23 Participants46 Participants
Surgery (sleeve resection (LSG)or gastric bypass (LGBP)
LSG
11 Participants9 Participants20 Participants
total body weight loss (TBWL) > 10%4 Participants18 Participants22 Participants
Total weight loss (TWL)3 Kg16 Kg7 Kg
Weight before surgery (Kg)121.3 Kg
STANDARD_DEVIATION 20.5
112.8 Kg
STANDARD_DEVIATION 16.4
117.2 Kg
STANDARD_DEVIATION 19

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 340 / 32
other
Total, other adverse events
8 / 347 / 32
serious
Total, serious adverse events
2 / 341 / 32

Outcome results

Primary

Postsurgical Morbidity on Both Arms of the Study

postsurgical morbidity includes all kind of post operative morbidity( mild ,moderate and severe) moderate and severe post surgical morbidity is the most important one

Time frame: within the 90 days after surgery

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Group BPostsurgical Morbidity on Both Arms of the Studypostsurgical morbidity10 Participants
Group BPostsurgical Morbidity on Both Arms of the Studymoderate-severe postsurgical morbidity8 Participants
IGB Group APostsurgical Morbidity on Both Arms of the Studypostsurgical morbidity8 Participants
IGB Group APostsurgical Morbidity on Both Arms of the Studymoderate-severe postsurgical morbidity4 Participants
p-value: 0.68995% CI: [0.53, 2.6]Chi-squared
Primary

Total Postsurgical Morbidity

total postsurgical morbidity included the morbidity specifically due to the Intragastric balloon plus all the postoperative morbidity related to the surgical procedure severe intragastric balloon morbidity refers only to medical complications which meet the criteria of severe of The accordion severity grading system .

Time frame: during the 6 months having the intragastric balloon and 90 days after surgery

Population: Group B did not receive an intra-gastric balloon, and was thus not evaluated for balloon related complications.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Group BTotal Postsurgical Morbiditytotal postsurgical morbidity10 Participants
IGB Group ATotal Postsurgical Morbidityintragastric balloon morbidity (complications)8 Participants
IGB Group ATotal Postsurgical Morbiditysevere intragastric balloon morbidity2 Participants
IGB Group ATotal Postsurgical Morbiditytotal postsurgical morbidity15 Participants
p-value: 0.14495% CI: [0.84, 3.01]Chi-squared
Secondary

Hospital Stay,

all in all hospital stay

Time frame: the period of the study started when patients were randomizated and finished 90 days after surgery

ArmMeasureValue (MEAN)Dispersion
Group BHospital Stay,10.3 daysStandard Deviation 15.3
IGB Group AHospital Stay,7 daysStandard Deviation 4.3
p-value: 0.937Wilcoxon (Mann-Whitney)
Secondary

Percentage of Re-operations

Percentage of Re-operations during all the period of the study ending within 90 days after surgery

Time frame: during all the period of the study ending within 90 days after surgery

ArmMeasureValue (NUMBER)
Group BPercentage of Re-operations11.8 percentage of participants
IGB Group APercentage of Re-operations6.3 percentage of participants
p-value: 0.673Fisher Exact
Secondary

Rate of Surgical Conversion to Open Surgery

number of patients with surgical conversion from laparoscopic to open surgery

Time frame: during the initial laparoscopic surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Group BRate of Surgical Conversion to Open Surgery1 Participants
IGB Group ARate of Surgical Conversion to Open Surgery1 Participants
p-value: 1Fisher Exact

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026