Creating a laparoscopIc banded sleeve gastrectomy

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 211

Inclusion Criteria

- Age between and 65 years
- BMI > 40 kg/m2
- BMI > 35 kg/m2 with comorbidities of which expect to improve after surgery
- Medical history of overweight for at least 5 years
- Proven failed attempts to lose weight in a conservative way, or initial good
result with relapse
- The intention to fully follow the postoperative program

Exclusion Criteria

- Mental disorder, psychotic disorder, severe depression and personality
disorder
- Never had professional medical guidance with weight loss
- Not able to participate in long-term medical checks
- Alcohol or drug abuse
- Diseases that form a threat on life expectancy on the short term
perioperavtively
- Patients who can not taken care for themselfs, or patients who do not have
any social network to take this responsibility
- Pregnacy
- BMI > 60 kg/m2 and/or a planned 'two stage' treatment with a SADI procedure
- Bariatric surgery in the medical history
- Patients with a language barrier which can have affect on medical follow-up
and treatment
- Patients with a disease not related to morbid obesity, e.g. Cushing or
medication related
- Chronic bowel diseases, e.g. M. Crohn, colitis ulcerosa
- Renal impairment (MDRD<30) of hepatic dysfunction (ASAT/ALAT twice the normal
value)
- Patients with therapy resistant reflux symptoms, defined as persistant
symptoms despite the use of maximum dose proton-pump-inhibitors (pantozol
2dd40mg/omeprazol 2dd40mg)
- Genetic cause of obesity
-

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Weight loss: Total body weight loss after 3 years</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Weight loss: Excess weight loss, Excess Body Mass Index loss<br /><br>Complications and reoperations<br /><br>Reduction of comorbidities: tyhpe 2 diabetes, hypertension, hypercholesteromie,<br /><br>jointcomplaints, OSAS<br /><br>Quality of life: BARS, SF36 and Body Q<br /><br>Reflux: GERD-HRQL<br /><br>f- Food tolerance: F1.10 Quality of Alimentation + additional food groups op 3<br /><br>and 5 jyears postoperatively </p><br>