NCT00504036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
314

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

November 1, 2011

Status Verified

October 1, 2008

Enrollment Period

3.8 years

First QC Date

July 18, 2007

Last Update Submit

October 31, 2011

Conditions

Morbid Obesity

Keywords

ObesityMorbid obesityGastric balloonGastric by-passMorbid obesity with BMI > 45 kg/m²

Outcome Measures

Primary Outcomes (1)

  • Rate of admission in Intensive Care Units

    > 24 hrs during the 30-day period following gastric by-pass

Secondary Outcomes (6)

  • Differences in absolute weight loss

    at 6 months, before gastric by-pass, between the 2 strategies

  • Number and types of complications occurring

    during the 30-day post-operative period

  • Number of comorbidities present

    after the 6-month initial period

  • Differences in quality of life

    at the end of first 6-month period and at the end of the study

  • Differences in time of surgery, length of stay, readmission

    during the 30-day post by-pass period

  • +1 more secondary outcomes

Study Arms (2)

Intra-gastric balloon

EXPERIMENTAL

Patients will receive either an air-filled or water-filled intra-gastric balloon.

Device: inflatable intra-gastric balloon

Usual care

NO INTERVENTION

Usual care will be given to the patients.

Interventions

inflatable intra-gastric balloonDEVICE

inflatable intra-gastric balloon

Intra-gastric balloon

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Louis Mourier

Colombes, 92700, France

Location

Related Publications (1)

  • 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.

    PMID: 17253531RESULT

MeSH Terms

Conditions

Obesity, MorbidObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benoit Coffin, PU-PH

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2007

First Posted

July 19, 2007

Study Start

October 1, 2007

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

November 1, 2011

Record last verified: 2008-10

Locations

FR(1)