Clinical trial NCT00722995: Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass
Official title: Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass. Study Comparing Complications, Efficacy and Quality of Life.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Morbid obesity
Sleeve gastrectomy
Gastric bypass
Complications
Efficacity
Safety
Compare
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-07-28
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility 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

Primary outcomes:
measure: Composite criteria of morbid/mortality
timeFrame: during 18 months and 36 months
Secondary outcomes:
measure: Frequency of morbid events
timeFrame: during the follow up
measure: Percentage of excess weight loss
timeFrame: during 18 and 36 months
measure: Frequency of patients having a excess weight loss superior than 50%
timeFrame: during 36 months
measure: Regression of morbidities
timeFrame: during 36 months
measure: Rate serum ghrelin
timeFrame: at inclusion visit, 6, 12, 18 and 36 months
measure: Evaluation of quality of life and scores of precariousness, SF 36, EPWORTH Score, Lequesne' Score, Insecure' Score
timeFrame: at inclusion visit, 6, 12, 18 and 36 months
measure: Frequency of morbid/mortality events
timeFrame: during 36 months
measure: Frequency of patients having excess weight loss superior than 50%
timeFrame: during 18 month
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Service de chirurgie digestive / Centre Hospitalier Général de Saint-Denis Delafontaine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris / Hôpital De la Fontaine (St Denis)
name: Jean-Marc CATHELINE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: