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

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ClinicalTrials.gov Identifier: NCT01998243
Recruitment Status : Completed
First Posted : November 28, 2013
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
luis ramon rábago torre, Hospital Severo Ochoa

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.


Condition or disease Intervention/treatment Phase
Morbid Obesity Device: Intragastric Balloon (IGB), group A Other: diet, control group B Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Usefulness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity To Decrease Bariatric Surgery Morbidity
Study Start Date : January 2009
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IGB group A
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
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
Other Name: BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM

Other: diet, control group B
the intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet
Other Name: 1200 Kilocalories (Kcal) diet

Placebo Comparator: control group B
the intervention in this control group B was the specified diet (a hypocaloric diet of 1200 Kilocalories (Kcal)
Other: diet, control group B
the intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet
Other Name: 1200 Kilocalories (Kcal) diet




Primary Outcome Measures :
  1. Postsurgical Morbidity on Both Arms of the Study [ Time Frame: within the 90 days after surgery ]
    postsurgical morbidity includes all kind of post operative morbidity( mild ,moderate and severe) moderate and severe post surgical morbidity is the most important one

  2. Total Postsurgical Morbidity [ Time Frame: during the 6 months having the intragastric balloon and 90 days after surgery ]
    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 ".


Secondary Outcome Measures :
  1. Hospital Stay, [ Time Frame: the period of the study started when patients were randomizated and finished 90 days after surgery ]
    all in all hospital stay

  2. Rate of Surgical Conversion to Open Surgery [ Time Frame: during the initial laparoscopic surgery ]
    number of patients with surgical conversion from laparoscopic to open surgery

  3. Percentage of Re-operations [ Time Frame: during all the period of the study ending within 90 days after surgery ]
    Percentage of Re-operations during all the period of the study ending within 90 days after surgery



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998243


Locations
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Spain
Gastroenterology Department ,Severo Ochoa Hospital
Leganés, Madrid, Spain, 28911
Sponsors and Collaborators
Hospital Severo Ochoa
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Luis R Rábago, MD,PhD

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: luis ramon rábago torre, Dr. Phd Luis Ramon Rábago Torre, Hospital Severo Ochoa
ClinicalTrials.gov Identifier: NCT01998243     History of Changes
Other Study ID Numbers: fis PI070682
FIS PI070682 ( Other Grant/Funding Number: SPANISH NATIONAL HEALTH SYSTEM, LAIN ENTRALGO AGENCY )
First Posted: November 28, 2013    Key Record Dates
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by luis ramon rábago torre, Hospital Severo Ochoa:
morbid obesity
bioenterics intragastric balloon
bariatric surgery
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms