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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Hospital Severo Ochoa
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
luis ramon rábago torre, Hospital Severo Ochoa
ClinicalTrials.gov Identifier:
NCT01998243
First received: November 19, 2013
Last updated: November 23, 2013
Last verified: November 2013
  Purpose

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 Intervention
Morbid Obesity
Device: preoperative intragastric balloon ( IGB-BIB®)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Usefulness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity To Decrease Bariatric Surgery Morbidity

Resource links provided by NLM:


Further study details as provided by Hospital Severo Ochoa:

Primary Outcome Measures:
  • morbidity rate [ Time Frame: wihtin the 90 days after surgery ] [ Designated as safety issue: Yes ]
    we checked total morbidity which included Intragastric balloon related morbidity ,postsurgical morbidity and mortality


Secondary Outcome Measures:
  • hospital stay [ Time Frame: during all the period of the study ending within 90 days after surgery ] [ Designated as safety issue: Yes ]
    all in all hospital stay

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


Estimated Enrollment: 80
Study Start Date: January 2009
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
  • with BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. - Morbid obesity (BMI ≥ 40 kg/m2 ) with medical indication for bariatric surgery and with failure of conventional treatment (diet and drugs)
  2. - Patients older than 18 y-old and younger than 80
  3. - The type of bariatric surgery proposed had to be laparoscopic gastric sleeve or laparoscopic gastric by-pass iatric surgery .

Exclusion Criteria:

  1. - slight adherence to previous medical treatments .
  2. - Hiatal hernia more than 3 cms
  3. - peptic ulcer
  4. - severe esophagitis
  5. - psychiatric diseases
  6. - Severe disease not amenable to improve with weight loss, and with implication of decreasing life expectancy (cancer, symptomatic ischemic cardiopathy or terminal renal failure )
  7. - Patients gastrectomized
  8. - Patients with previous antireflux surgery
  9. - Inflammatory bowel diseases
  10. - Patients with indication or already been on anticoagulant treatment .
  11. - Addiction to Drugs or alcohol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998243

Contacts
Contact: luis r rabago, MD,PhD 34916434546 lrabagot@gmail.com
Contact: cristina vicente, MD 34654622581 crisvimar4@gmail.com

Locations
Spain
Gastroenterology Department ,Severo Ochoa Hospital Recruiting
Leganés, Madrid, Spain, 28911
Contact: Isabel Pua BLanco    034914818000    isabel.pua@salud.madrid.or   
Contact: Dolores Del Olmo, MD    034914818000    dolmo.hsvo@salud.madrid.org   
Sub-Investigator: Dolores Del olmo, MD         
Sponsors and Collaborators
Hospital Severo Ochoa
Instituto de Salud Carlos III
Investigators
Principal Investigator: Luis R Rábago, MD,PhD
  More Information

Publications:
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
Study First Received: November 19, 2013
Last Updated: November 23, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Severo Ochoa:
morbid obesity
bioenteric intragastric balloon
bariatric surgery

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

ClinicalTrials.gov processed this record on November 20, 2014