Morbid ObesityBIGPOMNCT00504036
Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass
A study testing inflatable intra-gastric balloon in people with Morbid Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- inflatable intra-gastric balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Morbid Obesity
- Being tested
- inflatable intra-gastric balloon
- Keywords
- Obesity, Morbid obesity, Gastric balloon, Gastric by-pass, Morbid obesity with BMI > 45 kg/m²
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inflatable intra-gastric balloonDevice
inflatable intra-gastric balloon
| Study group | Role | What they receive |
|---|---|---|
| Intra-gastric balloon | Experimental | Patients will receive either an air-filled or water-filled intra-gastric balloon. Receives: Device: inflatable intra-gastric balloon |
| Usual care | No intervention | Usual care will be given to the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of admission in Intensive Care Units
Measured: > 24 hrs during the 30-day period following gastric by-pass
Secondary outcomes (6)
Differences in absolute weight loss
Measured: at 6 months, before gastric by-pass, between the 2 strategies
Number and types of complications occurring
Measured: during the 30-day post-operative period
Number of comorbidities present
Measured: after the 6-month initial period
Differences in quality of life
Measured: at the end of first 6-month period and at the end of the study
Differences in time of surgery, length of stay, readmission
Measured: during the 30-day post by-pass period
Differences in medical costs between the 2 strategies
Measured: 6 months before and after gastric by-pass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startOct 2007
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Coffin, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00504036
- Sponsor's protocol ID
- P060408
- Acronym
- BIGPOM
- Status last verified
- Oct 2008
- First submitted
- 18 Jul 2007
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17253531
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00504036
- Acronym / sponsor ID
- BIGPOM / P060408
- Conditions
- Morbid Obesity
- Keywords
- Obesity, Morbid obesity, Gastric balloon, Gastric by-pass, Morbid obesity with BMI > 45 kg/m²
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-gastric balloon | Experimental | Device: inflatable intra-gastric balloonPatients will receive either an air-filled or water-filled intra-gastric balloon. |
| Usual care | No intervention | –Usual care will be given to the patients. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inflatable intra-gastric ballooninflatable intra-gastric balloon | Device | Intra-gastric balloon |
Primary outcome
Rate of admission in Intensive Care Units
Time frame: > 24 hrs during the 30-day period following gastric by-pass
6 secondary outcomes
Differences in absolute weight loss
Time frame: at 6 months, before gastric by-pass, between the 2 strategies
Number and types of complications occurring
Time frame: during the 30-day post-operative period
Number of comorbidities present
Time frame: after the 6-month initial period
Differences in quality of life
Time frame: at the end of first 6-month period and at the end of the study
Differences in time of surgery, length of stay, readmission
Time frame: during the 30-day post by-pass period
Differences in medical costs between the 2 strategies
Time frame: 6 months before and after gastric by-pass
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2011.
- Results publication: PubMed 17253531Fernandes 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.
Related trials for Morbid Obesity
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Not yet recruitingObservational study
Evaluating Metabolic Health in Individuals With Extreme Obesity
BMI>40
Enrolling by invitationObservational study
Bariatric Surgery Registry
Obesity, Morbid
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Coffin, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inflatable intra-gastric balloon in people with Morbid Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of admission in Intensive Care Units (time frame: > 24 hrs during the 30-day period following gastric by-pass). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00504036, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2011.