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

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Morbid Obesity

Intervention / Treatment
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* Device: Intragastric Balloon (IGB), group A
* Other: diet, control group B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Morbid obesity (BMI ≥ 40 kg/m2 ) with a failed Conventional Medical treatment - Morbid obesity (BMI ≥ 35 kg/m2) with important comorbidity with a failed Conventional Medical treatment - they should be operated by a laparoscopic gastric sleeve or by laparoscopic gastric by-pass Exclusion Criteria: - Slight adherence to previous medical treatments . - Hiatal hernia more than 3 cms - Patients with active gastric or duodenal ulcer disease - Severe esophagitis - Psychiatric diseases (depression, bulimia etc) - Associated Severe Systemic Disease not amenable to improve with weight loss - Patients with Inflammatory bowel diseases - Patients on anticoagulant treatment or steroids . - Addiction to Drugs or alcohol - Past history of gastric surgery ,antireflux surgery or any other type of bariatric surgery - Patient refusing to be followed 6 months before and after surgery - Pregnancy or foreseeable pregnancy during the study - Patients with gastric or esophageal varices - proton pump inhibitor (PPI) allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IGB group A<br>the intervention in the group A : was to place a preoperative intragastric balloon (IGB-BIB®) in the stomach for 6 months before surgery plus an hypocaloric diet 1200 Kilocalories (Kcal) | Device: Intragastric Balloon (IGB), group A<br>* 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<br>* Other names: BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM;Other: diet, control group B<br>* the intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet<br>* Other names: 1200 Kilocalories (Kcal) diet;|
| Placebo Comparator: control group B<br>the intervention in this control group B was the specified diet (a hypocaloric diet of 1200 Kilocalories (Kcal) | Other: diet, control group B<br>* the intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet<br>* Other names: 1200 Kilocalories (Kcal) diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | within the 90 days after surgery | 
| 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 . | during the 6 months having the intragastric balloon and 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Stay, | all in all hospital stay | the period of the study started when patients were randomizated and finished 90 days after surgery | 
| Rate of Surgical Conversion to Open Surgery | number of patients with surgical conversion from laparoscopic to open surgery | during the initial laparoscopic surgery | 
| Percentage of Re-operations | Percentage of Re-operations during all the period of the study ending within 90 days after surgery | during all the period of the study ending within 90 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bioenterics intragastric balloon, bariatric surgery, morbid obesity