E66
Conditions
Interventions
Group 1: laparoscopic sleeve gastrectomy without MiniMizer Ring
Group 2: laparoscopic sleeve gastrectomy with MiniMizer Ring
Sponsors
Universitätsklinikum Freiburg
Abt. Allgemein- und Viszeralchirurgie
Eligibility
Sex/Gender
All
Age
19 Years to 64 Years
Inclusion criteria
Inclusion criteria: ->18 and = 35kg/m2 and existence of obesety-related comorbiditys as there are: type 2 diabetes mellitus, arterial hypertension, sleep apnea, degenerative diseases of the spine or knees, or BMI >=40kg/m2, signed informed consent
Exclusion criteria
Exclusion criteria: -history of obesity surgery -history of major abdominal surgery with resection of the stomach, small and large bowel (exception: appendectomym cholecystectomy, umbilical hernia repair, incisional hernia repair, ingual hernia repair), Patients not eligible to implement silastic ring, history of drug or alcohol abuse, history of major psychiatric illness conflicting with patient´s compliance, lack of compliance, autoimmune disease, inflammatory bowel disease or malabsorptive disease, liver cirrhosis (CHILD A, B, C), active viral or bacterial disease, pregnant women or women with childbearing potential without efficient contraception, history of cancer in the last five years, severe gastroesophageal reflux disease with Barrett´s dysplasia or hiatal hernia >5cm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss after 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c, number of antidiabetic drugs, blood pressure, number of antihypertension drugs, triglycerides, LDL, HDL, total cholersterol, occurence of reflux, dysphagia, occurence of adverse events, operation time, hosptal stay, Occurence of postsurgical regurgitation after 1, 3, 6, 12 and 36 months, volume of gastric sleeve after 1 and 3 years (MRI) | — |
Countries
Germany
Contacts
Public ContactJodok Fink
Universitätsklinikum Freiburg Abt. Allgemein- und Viszeralchirurgie
Outcome results
None listed