Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass (SLEEVE)
This study is ongoing, but not recruiting participants.
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00722995
First received: July 25, 2008
Last updated: November 21, 2012
Last verified: November 2012
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Purpose
The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit than the gastric bypass
| Condition | Intervention |
|---|---|
|
Obesity |
Procedure: Sleeve gastrectomy Procedure: Gastric Bypass |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass. Study Comparing Complications, Efficacy and Quality of Life. |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- Composite criteria of morbid/mortality [ Time Frame: during 18 months and 36 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Frequency of morbid events [ Time Frame: during the follow up ] [ Designated as safety issue: Yes ]
- Percentage of excess weight loss [ Time Frame: during 18 and 36 months ] [ Designated as safety issue: Yes ]
- Frequency of patients having a excess weight loss superior than 50% [ Time Frame: during 36 months ] [ Designated as safety issue: Yes ]
- Regression of morbidities [ Time Frame: during 36 months ] [ Designated as safety issue: Yes ]
- Rate serum ghrelin [ Time Frame: at inclusion visit, 6, 12, 18 and 36 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- Frequency of morbid/mortality events [ Time Frame: during 36 months ] [ Designated as safety issue: Yes ]
- Frequency of patients having excess weight loss superior than 50% [ Time Frame: during 18 month ] [ Designated as safety issue: Yes ]
| Enrollment: | 280 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Sleeve gastrectomy
|
Procedure: Sleeve gastrectomy
Laparoscopic sleeve gastrectomy is a restrictive procedure for the treatment for morbid obesity
Other Name: SLEEVE
|
|
Active Comparator: 2
Gastric Bypass
|
Procedure: Gastric Bypass
Laparoscopic gastric bypass is a restrictive and difficult absorption procedure for the treatment of morbid obesity
Other Name: 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722995
Locations
| France | |
| Service de chirurgie digestive / Centre Hospitalier Général de Saint-Denis Delafontaine | |
| Saint-Denis, France, 93205 | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| Principal Investigator: | Jean-Marc CATHELINE, MD, PhD | Assistance Publique - Hôpitaux de Paris / Hôpital De la Fontaine (St Denis) |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00722995 History of Changes |
| Other Study ID Numbers: | K060213 |
| Study First Received: | July 25, 2008 |
| Last Updated: | November 21, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Morbid obesity Sleeve gastrectomy Gastric bypass Complications |
Efficacity Safety Compare |
Additional relevant MeSH terms:
|
Obesity Obesity, Morbid Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013