ObesitySLEEVENCT00722995
Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass
A study testing Sleeve gastrectomy and Gastric Bypass in people with Obesity, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit than the gastric bypass Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Sleeve gastrectomy and Gastric Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Apr 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient aged from 18 to 60 years old
- Patient having given his consent to the use of data from the project
- Patient fulfilling the inclusion criteria for surgery of obesity according to the ANAES (french national health service)
- Patient presenting one of the following criteria:
- A morbid obesity strict with BMI> 40
- A super obesity BMI> 50
Show all 10Show fewer
- A super super obesity BMI> 60
- Obese patient in failure following the installation of a gastric banding with BMI> 35
- obese patient 35>BMI>40 with a comorbidity
- Preliminary agreement during the consultation of a psychiatrist / psychologist
Who cannot join
- Patient with complications or co morbidities associated involving life to less 6 months
- Patient presenting no anaesthetic indication
- Patient presenting no psychiatric indication for obesity surgery
- Patient not affiliated with a social security scheme
- Pregnant Patient likely to breastfeed in the first year
Trial locations and contacts
1 site in 1 country.
France1 site
Service de chirurgie digestive / Centre Hospitalier Général de Saint-Denis Delafontaine
Saint-Denis, 93205
About this study
Official title: Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass. Study Comparing Complications, Efficacy and Quality of Life.
The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit than the gastric bypass
Read the detailed description
In the obese patient population, the frequency of patients presenting a severe morbid obesity (40 >= BMI <= 50), a super obesity (BMI >50), a super super obesity (BMI>60), and obese patients (BMI>35) with a failure of gastric banding is constantly increasing. In these patients, the surgery risk is proportionate to the weight and / or gastric surgery records.
This risk is high, in bariatric surgery, for gastric bypass procedure. This justifies the evaluation of new procedure to reduce the morbidity allowing the reduction of morbid /mortality associated with the intervention.
- Conditions
- Obesity
- Being tested
- Sleeve gastrectomy, Gastric Bypass
- Keywords
- Morbid obesity, Sleeve gastrectomy, Gastric bypass, Complications, Efficacity, Safety, Compare
- Medical subject headings
- Obesity, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomyProcedure or surgery
Also called SLEEVE
Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity
Gastric BypassProcedure or surgery
Also called BYPASS
Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Sleeve gastrectomy Receives: Procedure: Sleeve gastrectomy |
| 2 | Active comparator | Gastric Bypass Receives: Procedure: Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite criteria of morbid/mortality
Measured: during 18 months and 36 months
Secondary outcomes (8)
Frequency of morbid events
Measured: during the follow up
Percentage of excess weight loss
Measured: during 18 and 36 months
Frequency of patients having a excess weight loss superior than 50%
Measured: during 36 months
Regression of morbidities
Measured: during 36 months
Rate serum ghrelin
Measured: at inclusion visit, 6, 12, 18 and 36 months
Evaluation of quality of life and scores of precariousness, SF 36, EPWORTH Score, Lequesne' Score, Insecure' Score
Measured: at inclusion visit, 6, 12, 18 and 36 months
Frequency of morbid/mortality events
Measured: during 36 months
Frequency of patients having excess weight loss superior than 50%
Measured: during 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc CATHELINE, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris / Hôpital De la Fontaine (St Denis)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722995
- Sponsor's protocol ID
- K060213
- Acronym
- SLEEVE
- Status last verified
- Jun 2021
- First submitted
- 25 Jul 2008
- Last updated
- 15 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass. Study Comparing Complications, Efficacy and Quality of Life.
- ClinicalTrials.gov ID
- NCT00722995
- Acronym / sponsor ID
- SLEEVE / K060213
- Conditions
- Obesity
- Keywords
- Morbid obesity, Sleeve gastrectomy, Gastric bypass, Complications, Efficacity, Safety, Compare
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Jul 2008 (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 aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit than the gastric bypass
Detailed description
In the obese patient population, the frequency of patients presenting a severe morbid obesity (40 >= BMI <= 50), a super obesity (BMI >50), a super super obesity (BMI>60), and obese patients (BMI>35) with a failure of gastric banding is constantly increasing. In these patients, the surgery risk is proportionate to the weight and / or gastric surgery records.
This risk is high, in bariatric surgery, for gastric bypass procedure. This justifies the evaluation of new procedure to reduce the morbidity allowing the reduction of morbid /mortality associated with the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Sleeve gastrectomySleeve gastrectomy |
| 2 | Active comparator | Procedure: Gastric BypassGastric Bypass |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patient aged from 18 to 60 years old
- Patient having given his consent to the use of data from the project
- Patient fulfilling the inclusion criteria for surgery of obesity according to the ANAES (french national health service)
- Patient presenting one of the following criteria:
- Preliminary agreement during the consultation of a psychiatrist / psychologist
Key exclusion criteria (5 listed)
- Patient with complications or co morbidities associated involving life to less 6 months
- Patient presenting no anaesthetic indication
- Patient presenting no psychiatric indication for obesity surgery
- Patient not affiliated with a social security scheme
- Pregnant Patient likely to breastfeed in the first year
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 |
|---|---|---|
| Sleeve gastrectomyAlso: SLEEVELaparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity | Procedure or surgery | 1 |
| Gastric BypassAlso: BYPASSLaparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity | Procedure or surgery | 2 |
Primary outcome
Composite criteria of morbid/mortality
Time frame: during 18 months and 36 months
8 secondary outcomes
Frequency of morbid events
Time frame: during the follow up
Percentage of excess weight loss
Time frame: during 18 and 36 months
Frequency of patients having a excess weight loss superior than 50%
Time frame: during 36 months
Regression of morbidities
Time frame: during 36 months
Rate serum ghrelin
Time frame: at inclusion visit, 6, 12, 18 and 36 months
Evaluation of quality of life and scores of precariousness, SF 36, EPWORTH Score, Lequesne' Score, Insecure' Score
Time frame: at inclusion visit, 6, 12, 18 and 36 months
Frequency of morbid/mortality events
Time frame: during 36 months
Frequency of patients having excess weight loss superior than 50%
Time frame: during 18 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 15 Jun 2021.
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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.
Jean-Marc CATHELINE, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris / Hôpital De la Fontaine (St Denis)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeve gastrectomy and Gastric Bypass in people with 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 10 inclusion and 5 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 15 Jun 2021. 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?
Composite criteria of morbid/mortality (time frame: during 18 months and 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2021.