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

Morbid Obesity Clinical Trial

— BIGPOM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00504036
• Other study ID #: P060408
• Status: Completed
• Phase: N/A
• First received: July 18, 2007
• Last updated: October 31, 2011
• Start date: October 2007
• Est. completion date: July 2011

Study information

• Verified date: October 2008
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 314
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Device:
• inflatable intra-gastric balloon
inflatable intra-gastric balloon

Locations

Country	Name	City	State
France	Hopital Louis Mourier	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Fernandes M, Atallah AN, Soares BG, Humberto S, Guimarães S, Matos D, Monteiro L, Richter B. Intragastric balloon for obesity. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD004931. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of admission in Intensive Care Units		> 24 hrs during the 30-day period following gastric by-pass	Yes
Secondary	Differences in absolute weight loss		at 6 months, before gastric by-pass, between the 2 strategies	Yes
Secondary	Number and types of complications occurring		during the 30-day post-operative period	Yes
Secondary	Number of comorbidities present		after the 6-month initial period	No
Secondary	Differences in quality of life		at the end of first 6-month period and at the end of the study	Yes
Secondary	Differences in time of surgery, length of stay, readmission		during the 30-day post by-pass period	Yes
Secondary	Differences in medical costs between the 2 strategies		6 months before and after gastric by-pass	Yes