Gastric Volumetry by Gastric Tomodensitometry With Gas (VOLUSCAN)
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
gastric tomodensitometry with gas at 3 months and 12 months
Sponsored by
About this trial
This is an interventional diagnostic trial for Morbid Obesity focused on measuring obesity, sleeve gastrectomy, gastric bypass, gastric tomodensitometry, gastric pouch size, weight regain
Eligibility Criteria
Inclusion Criteria:
- Patients of both genders, with morbid obesity (BMI > or = 40kg / m ²)
- Age included between 18 and 60 years
- Patient who requires a gastric bypass or a Sleeve gastrectomy as a 1st bariatric procedure. Indication validated in pluridisciplinary concertation meeting for bariatric surgery
- No previous history of bariatric surgery
- Free and informed consent signed
- Being affiliated to a French social security system or similar.
Exclusion Criteria:
- Bariatric surgery with metabolic aim (BMI < 40kg / m ²)
- Patients with a history of bariatric surgery, after failure of one or several previous procedures
- Contraindication to radiation exposition: current or planned pregnancy during the study
- prostate adenoma : contraindication to antispasmodic
- Known allergy to effervescent salts or butylscopolamine (Scoburen)
- Glaucoma
- Inability to express a consent
- Unaffiliated patients to a French national insurance
- Patients with Pacemaker
- Patients already enrolled in a study with a conflict of interest with this study.
Sites / Locations
- Hospices Civils de Lyon- hôpital Edouard Herriot- service de Chirurgie Digestive
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with morbid obesity
Arm Description
Patients with morbid obesity and who requires a gastric bypass or a Sleeve gastrectomy as a 1st bariatric procedure.
Outcomes
Primary Outcome Measures
the neostomach volume measured by gastrictomodensitometry with gas
the subjects' weight at the 3rd and the 12th month after GBP or SG
Secondary Outcome Measures
the neostomach volume at 12 months and total weightloss
determination of the positive predictive value of the neostomach volume at 3 months, on weight evolution at 12 months after GBP or SG
the volume of the neostomach at 3 and 12 months between the subjects who gain weight and thosewho do not
standard values for gastricvolumetry by gastrictomodensitometry with gas, at 3 and 12 months after GBP or SG
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01963637
Brief Title
Gastric Volumetry by Gastric Tomodensitometry With Gas
Acronym
VOLUSCAN
Official Title
Evolution of Gastric Volume Measured by Gastric Tomodensitometry With Gas After Gastric Bypass Surgery or Sleeve Gastrectomy. Research for a Correlation With Weight Evolution : Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The Gastric bypass (GBP) is actually one of the most performed bariatric procedures worldwide. Short term results report 67% of mean Excess Weight Loss (EWL) at 2 years, and 58% EWL at 5 years. Sleeve gastrectomy (SG) which is a restrictive procedure has gained in popularity because of its technical simplicity and its efficiency (60% EWL at 1 year and 48% over 4 years). However, failures are observed because of insufficient weight loss or early weight regain. Several hypotheses have been proposed to explain these failures, such as the size of the gastric pouch that could be correlated to weight evolution.
Purpose of the study Taking the hypothesis that a progressive dilatation of the gastric pouch is one of the main factors of weight loss failure after GBP or SG due to the loss of its restrictive function, the aim of our study is to measure these gastric volumes using gastric tomodensitometry with gas, a new reliable,precise and 3 dimension radiological technique. The investigators will try to identify a positive correlation between gastric dilatation and weight regain.
Methods This is a 2 year interventional, prospective, monocentric study with longitudinal follow-up. Forty-five obese patients (BMI>40kg/m²) eligible for primary GBP (n=25) or SG (n=20) will be included. Gastric volumes will be measured by gastric tomodensitometry with gas at 3 and 12 month after surgery. In the GBP group, the investigators will measure the gastric pouch volume, the candy cane Roux limb volume, the neostomach volume (= gastric pouch+candy cane Roux limb) and the gastro-jejunal anastomosis diameter. In the SG group, the investigators will measure the volume of the gastric tube, of the non resectedantrum, of the whole residual stomach and the gastric tube diameter at the middle of the small curvature. Volume variations between 3 and 12 months will be compared to the EWL and to clinical and metabolic data (HbA1c, Insulinemia, HOMA index, liver steatosis). A 30% dilatation of the neostomach at 12 months will be considered as significant. Reinhold's criteria will be used to define surgical failure: EWL<50% at 12 months. Weight regain will be considered as significant if the weight reached at 12 months is higher than the minimum weight obtained. Gastric volume variation, EWL and BMI evolution between the 3rd and the 12th month will be analysed in the whole population and in each group (GBP and SG) with a Wilcoxon test.
Expected benefits If the investigators valid the hypothesis that the dilatation of the neostomach is an essential factor in weight regain after GBP and SG, the benefit for the patient will be dual: 1/ validate the prognostic value of gastric volumetry by gastric tomodensitometry with gas in order to explain weight regain, and in order to use it as a standard. 2/ the identification of specific risk factors related to the surgical procedure could result in surgical technique improvements as well as a better adaptation of revisional procedures, in order to improve treatment of recurrent obesity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
obesity, sleeve gastrectomy, gastric bypass, gastric tomodensitometry, gastric pouch size, weight regain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with morbid obesity
Arm Type
Experimental
Arm Description
Patients with morbid obesity and who requires a gastric bypass or a Sleeve gastrectomy as a 1st bariatric procedure.
Intervention Type
Device
Intervention Name(s)
gastric tomodensitometry with gas at 3 months and 12 months
Primary Outcome Measure Information:
Title
the neostomach volume measured by gastrictomodensitometry with gas
Time Frame
3 and 12 month
Title
the subjects' weight at the 3rd and the 12th month after GBP or SG
Time Frame
3 and 12 months
Secondary Outcome Measure Information:
Title
the neostomach volume at 12 months and total weightloss
Time Frame
12 month
Title
determination of the positive predictive value of the neostomach volume at 3 months, on weight evolution at 12 months after GBP or SG
Time Frame
3 and 12 month
Title
the volume of the neostomach at 3 and 12 months between the subjects who gain weight and thosewho do not
Time Frame
3 and 12 month
Title
standard values for gastricvolumetry by gastrictomodensitometry with gas, at 3 and 12 months after GBP or SG
Time Frame
3 and 12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of both genders, with morbid obesity (BMI > or = 40kg / m ²)
Age included between 18 and 60 years
Patient who requires a gastric bypass or a Sleeve gastrectomy as a 1st bariatric procedure. Indication validated in pluridisciplinary concertation meeting for bariatric surgery
No previous history of bariatric surgery
Free and informed consent signed
Being affiliated to a French social security system or similar.
Exclusion Criteria:
Bariatric surgery with metabolic aim (BMI < 40kg / m ²)
Patients with a history of bariatric surgery, after failure of one or several previous procedures
Contraindication to radiation exposition: current or planned pregnancy during the study
prostate adenoma : contraindication to antispasmodic
Known allergy to effervescent salts or butylscopolamine (Scoburen)
Glaucoma
Inability to express a consent
Unaffiliated patients to a French national insurance
Patients with Pacemaker
Patients already enrolled in a study with a conflict of interest with this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MAUD ROBERT, MD
Organizational Affiliation
Hospices Civils de Lyon- Hôpital Edouard Herriot
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon- hôpital Edouard Herriot- service de Chirurgie Digestive
City
Lyon
ZIP/Postal Code
69003
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
25500226
Citation
Robert M, Pechoux A, Marion D, Laville M, Gouillat C, Disse E. Relevance of Roux-en-Y gastric bypass volumetry using 3-dimensional gastric computed tomography with gas to predict weight loss at 1 year. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):26-31. doi: 10.1016/j.soard.2014.05.014. Epub 2014 May 23.
Results Reference
result
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Gastric Volumetry by Gastric Tomodensitometry With Gas
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