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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01998243
Recruitment Status : Recruiting
First Posted : November 28, 2013
Last Update Posted : August 17, 2016
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" vs a control group "B" with the same type of surgical procedures but without preoperative IGB-BIB. 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: preoperative intragastric balloon ( IGB-BIB®) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Usefulness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity To Decrease Bariatric Surgery Morbidity
Study Start Date : January 2009
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

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U.S. FDA Resources

Arm Intervention/treatment
No Intervention: group B
patients were followed during at least 6 months before surgery by the same group of nutritionist that followed the group A and with the same type of diet and diet recommendations
Active Comparator: IGB-BIB® group A
patients included have a preoperative intragastric balloon during a period of 6 months before operation
Device: 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
Other Names:
  • Endoscopic Intra Gastric Balloon(IGB)

Primary Outcome Measures :
  1. morbidity and mortality on both arms of the study [ Time Frame: within the 90 days after surgery ]
    we checked total morbidity and mortality which included Intragastric balloon related morbidity ,postsurgical morbidity and mortality

Secondary Outcome Measures :
  1. hospital stay, [ Time Frame: during all the period of the study ending within 90 days after surgery ]
    all in all hospital stay

  2. factors associated with surgical morbidity [ Time Frame: during the preoperative period of the study and within the 90 days after surgery ]
    multivariate regression analysis to assess the factors related with morbidity (weight before surgery, age,type of surgery?)

  3. rate or surgical conversion to open surgery [ Time Frame: during all the period of the study ending within 90 days after surgery ]
    all in all hospital stay

  4. rate of reoperations [ Time Frame: during all the period of the study ending within 90 days after surgery ]
    all in all hospital stay

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

Inclusion Criteria:

  1. - Patients older than 18 and younger than 80 y-o
  2. - Morbid obesity (BMI ≥ 40 kg/m2 ) with indication for laparoscopic bariatric surgery or Morbid obesity (BMI ≥ 35 kg/m2) with important comorbidity
  3. - Conventional Medical treatment (diet and drugs) should have failed before
  4. - Patients included should be operated by a laparoscopic gastric sleeve or by laparoscopic gastric by-pass
  5. - Obesity should no be secondary to any other systemic disease
  6. - Firmed informed consent

Exclusion Criteria:

  1. - slight adherence to previous medical treatments .
  2. - Hiatal hernia more than 3 cms
  3. - Patients with gastric or duodenal ulcer disease not treated and cured
  4. - Severe esophagitis
  5. - Psychiatric diseases (depression, bulimia etc)
  6. - Associated Severe Systemic Disease not amenable to improve with weight loss, and with implication ON decreasing life expectancy (cancer, symptomatic ischemic cardiopathy or terminal renal failure )
  7. - Patients with previous antireflux surgery
  8. - Patients with Inflammatory bowel diseases
  9. - Patients with indication or already been on anticoagulant treatment .
  10. - Addiction to Drugs or alcohol
  11. - Past history of gastric surgery,or any other type of bariatric surgery or gastric complication related to gastric lap-band
  12. - Patient refusing to be followed 6 months before and after surgery
  13. - Pregnancy or foreseeable pregnancy during the study
  14. - Patients taking anticoagulant agents or steroids
  15. - Patients with gastric or esophageal varices
  16. - 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 identifier (NCT number): NCT01998243

Contact: luis r rabago, MD,PhD 34916434546
Contact: cristina vicente, MD 34654622581

Gastroenterology Department ,Severo Ochoa Hospital Recruiting
Leganés, Madrid, Spain, 28911
Contact: Isabel Pua BLanco    034914818000   
Contact: Dolores Del Olmo, MD    034914818000   
Sub-Investigator: Dolores Del olmo, MD         
Sponsors and Collaborators
Hospital Severo Ochoa
Instituto de Salud Carlos III
Principal Investigator: Luis R Rábago, MD,PhD

Responsible Party: luis ramon rábago torre, Dr. Phd Luis Ramon Rábago Torre, Hospital Severo Ochoa Identifier: NCT01998243     History of Changes
Other Study ID Numbers: fis PI070682
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by luis ramon rábago torre, Hospital Severo Ochoa:
morbid obesity
bioenterics intragastric balloon
bariatric surgery

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms