Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass (BIGPOM)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00504036
First received: July 18, 2007
Last updated: October 31, 2011
Last verified: October 2008
  Purpose

To demonstrate, during a prospective randomized medico-economic study, in morbidly obese patients (BMI > 45 kg/m²) selected for a laparoscopic gastric by-pass that, in comparison to usual care, a temporary intra-gastric balloon (6 months) decreases medical costs and peri-operative morbidity.


Condition Intervention
Morbid Obesity
Device: inflatable intra-gastric balloon

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Medico Economic Evaluation of a Temporary (6 Months) Intra-gastric Balloon in Morbidly Obese Patients Before a Gastric By-pass. A Randomised Multicenter Study Comparing the Usual Strategy to Two Types of Gastric Balloon

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Rate of admission in Intensive Care Units [ Time Frame: > 24 hrs during the 30-day period following gastric by-pass ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Differences in absolute weight loss [ Time Frame: at 6 months, before gastric by-pass, between the 2 strategies ] [ Designated as safety issue: Yes ]
  • Number and types of complications occurring [ Time Frame: during the 30-day post-operative period ] [ Designated as safety issue: Yes ]
  • Number of comorbidities present [ Time Frame: after the 6-month initial period ] [ Designated as safety issue: No ]
  • Differences in quality of life [ Time Frame: at the end of first 6-month period and at the end of the study ] [ Designated as safety issue: Yes ]
  • Differences in time of surgery, length of stay, readmission [ Time Frame: during the 30-day post by-pass period ] [ Designated as safety issue: Yes ]
  • Differences in medical costs between the 2 strategies [ Time Frame: 6 months before and after gastric by-pass ] [ Designated as safety issue: Yes ]

Enrollment: 314
Study Start Date: October 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intra-gastric balloon
Patients will receive either an air-filled or water-filled intra-gastric balloon.
Device: inflatable intra-gastric balloon
inflatable intra-gastric balloon
Other Name: inflatable intra-gastric balloon
No Intervention: Usual care
Usual care will be given to the patients.

Detailed Description:

On inclusion, comorbidities associated with obesity will be recorded. After recording of the informed consent patients will be randomized in two groups: usual care or intra-gastric balloon. In the latter, a second randomization will be performed between air-filled balloon or water-filled balloon. Six months later, after withdrawal of the balloon (if required), laparoscopic gastric by-pass will be performed. Thereafter, patients will be followed during 6 months.

On each visit, inclusion, 3 months, 6 months, surgery, 1 month and 6 months post surgery, a medical and biological evaluation will be systematically performed.

The main criteria of judgement is the rate of admission in ICU during more than 24 hrs during the 30 days following surgery.

The secondary criteria of judgement is: the differences in pre-operative weight loss between the 2 groups, number of complications occurring during the 30 days after surgery, differences in different scales of quality of life (SF36, IWQOL-lite), differences in operative time, length of hospital stay, readmissions, and medical cots between the two strategies. Efficacy and tolerance of each type of balloon (air-filled or water-filled) will be compared in the intra-gastric balloon group.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 75 years
  • Patients with morbid obesity with BMI > 45 kg/m² requiring a gastric by-pass by laparoscopy.
  • No efficacy of previous treatment on obesity
  • Firmed informed consent

Exclusion Criteria:

  • Patients in whom laparoscopy is contra-indicated
  • Indication of gastric by-pass by laparoscopy retained without multidisciplinary advice
  • Morbid obesity present since less than 5 years
  • Severe associated pathology, non-related to obesity, impairing vital prognosis on a short or mean time
  • Past history of gastric surgery, or gastric complication related to gastric lap-band
  • Lack of health insurance
  • Patient refusing to be followed 6 months before and after surgery
  • Drug abuse
  • Pregnancy or foreseeable pregnancy during the study
  • Patients taking anticoagulant agents or steroids
  • Patients with hiatal hernia > 4 cm
  • Patients with active ulcerated esophagitis (grade C-D in Los Angeles Classification)
  • Patients with duodenal or gastric ulcer
  • Patients with gastric or esophageal varices
  • Patients with NSAIDs not taking PPI
  • Patients with bulimia
  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: NCT00504036

Locations
France
Hopital Louis Mourier
Colombes, France, 92700
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Benoit Coffin, PU-PH Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00504036     History of Changes
Other Study ID Numbers: P060408
Study First Received: July 18, 2007
Last Updated: October 31, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Obesity
Morbid obesity
Gastric balloon
Gastric by-pass
Morbid obesity with BMI > 45 kg/m²

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

ClinicalTrials.gov processed this record on September 22, 2014