Clinical trial NCT00504036: Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Obesity
Morbid obesity
Gastric balloon
Gastric by-pass
Morbid obesity with BMI > 45 kg/m²
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-07-19
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Rate of admission in Intensive Care Units
timeFrame: > 24 hrs during the 30-day period following gastric by-pass
Secondary outcomes:
measure: Differences in absolute weight loss
timeFrame: at 6 months, before gastric by-pass, between the 2 strategies
measure: Number and types of complications occurring
timeFrame: during the 30-day post-operative period
measure: Number of comorbidities present
timeFrame: after the 6-month initial period
measure: Differences in quality of life
timeFrame: at the end of first 6-month period and at the end of the study
measure: Differences in time of surgery, length of stay, readmission
timeFrame: during the 30-day post by-pass period
measure: Differences in medical costs between the 2 strategies
timeFrame: 6 months before and after gastric by-pass
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hopital Louis Mourier
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Benoit Coffin, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fernandes M, Atallah AN, Soares BG, Humberto S, Guimaraes S, Matos D, Monteiro L, Richter B. Intragastric balloon for obesity. Cochrane Database Syst Rev. 2007 Jan 24;2007(1):CD004931. doi: 10.1002/14651858.CD004931.pub2.