Morbid ObesityVOLUSCANNCT01963637
Gastric Volumetry by Gastric Tomodensitometry With Gas
A study testing gastric tomodensitometry with gas at 3 months and 12 months in people with Morbid Obesity, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- gastric tomodensitometry with gas at 3 months and 12 months
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Jan 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices Civils de Lyon- hôpital Edouard Herriot- service de Chirurgie Digestive
Lyon, 69003
About this study
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.
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.
Read more
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.
- Conditions
- Morbid Obesity
- Being tested
- gastric tomodensitometry with gas at 3 months and 12 months
- Keywords
- obesity, sleeve gastrectomy, gastric bypass, gastric tomodensitometry, gastric pouch size, weight regain
- 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.
gastric tomodensitometry with gas at 3 months and 12 monthsDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients with morbid obesity | Experimental | Patients with morbid obesity and who requires a gastric bypass or a Sleeve gastrectomy as a 1st bariatric procedure. Receives: Device: gastric tomodensitometry with gas at 3 months and 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
the neostomach volume measured by gastrictomodensitometry with gas
Measured: 3 and 12 month
the subjects' weight at the 3rd and the 12th month after GBP or SG
Measured: 3 and 12 months
Secondary outcomes (4)
the neostomach volume at 12 months and total weightloss
Measured: 12 month
determination of the positive predictive value of the neostomach volume at 3 months, on weight evolution at 12 months after GBP or SG
Measured: 3 and 12 month
the volume of the neostomach at 3 and 12 months between the subjects who gain weight and thosewho do not
Measured: 3 and 12 month
standard values for gastricvolumetry by gastrictomodensitometry with gas, at 3 and 12 months after GBP or SG
Measured: 3 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startSep 2012
- Primary completionJan 2015
- Study completionJan 2015
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 Hospices Civils de LyonThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- MAUD ROBERT, MD, Principal investigator, Hospices Civils de Lyon- Hôpital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963637
- Sponsor's protocol ID
- 2012.721
- Other IDs
- 2012-A00591-42
- Acronym
- VOLUSCAN
- Status last verified
- Aug 2025
- First submitted
- 10 Oct 2013
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Robert M, Pasquer A, Pelascini E, Valette PJ, Gouillat C, Disse E. Impact of sleeve gastrectomy volumes on weight loss results: a prospective study. Surg Obes Relat Dis. 2016 Aug;12(7):1286-1291. doi: 10.1016/j.soard.2016.01.021. Epub 2016 Jan 25.
PubMed 27134194
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01963637
- Acronym / sponsor ID
- VOLUSCAN / 2012.721
- Conditions
- Morbid Obesity
- Keywords
- obesity, sleeve gastrectomy, gastric bypass, gastric tomodensitometry, gastric pouch size, weight regain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Oct 2013 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with morbid obesity | Experimental | Device: gastric tomodensitometry with gas at 3 months and 12 monthsPatients with morbid obesity and who requires a gastric bypass or a Sleeve gastrectomy as a 1st bariatric procedure. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
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 |
|---|---|---|
| gastric tomodensitometry with gas at 3 months and 12 months | Device | Patients with morbid obesity |
Primary outcome
the neostomach volume measured by gastrictomodensitometry with gas
Time frame: 3 and 12 month
the subjects' weight at the 3rd and the 12th month after GBP or SG
Time frame: 3 and 12 months
4 secondary outcomes
the neostomach volume at 12 months and total weightloss
Time frame: 12 month
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
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
standard values for gastricvolumetry by gastrictomodensitometry with gas, at 3 and 12 months after GBP or SG
Time frame: 3 and 12 month
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 4 Sep 2025.
- Results publication: PubMed 27134194Robert M, Pasquer A, Pelascini E, Valette PJ, Gouillat C, Disse E. Impact of sleeve gastrectomy volumes on weight loss results: a prospective study. Surg Obes Relat Dis. 2016 Aug;12(7):1286-1291. doi: 10.1016/j.soard.2016.01.021. Epub 2016 Jan 25.
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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.
MAUD ROBERT, MD principal investigator
Hospices Civils de Lyon- Hôpital Edouard Herriot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gastric tomodensitometry with gas at 3 months and 12 months in people with Morbid Obesity, run by Hospices Civils de Lyon 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 6 inclusion and 10 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 4 Sep 2025. 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?
the neostomach volume measured by gastrictomodensitometry with gas (time frame: 3 and 12 month). The study lists 2 primary outcomes in all. 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 NCT01963637, 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 4 Sep 2025.