Banded Versus Conventional Laparoscopic Sleeve Gastrectomy

Not Applicable

• Conditions: E66; Obesity

• Registration Number: DRKS00000809
• Lead Sponsor: niversitätsklinikum FreiburgAbt. Allgemein- und Viszeralchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-14
• Study Completion: 2012-04-13
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting withdrawn before recruiting started
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Age 18-60 Years
- BMI >=50 bis <=60
- signed informed consent
- Patients with on e or more of the following comorbidities: hypertension, diabetes mellitus type 2, Hyperlipidemia, Hyperuricemia, degenerative diseases of: spine osteochondrosis, hip, knee, feet

Exclusion Criteria

- history of obisity surgery
-history of major abdominal surgery with consecutive malabsorption (no resections of the stomach, small and large bowel (exception: appendectomy)
- Patient not eligible to implement silastic ring size 6,5
-history of drug or alcohol abuse
-history of major psychiatric illness conflicting with patient´s compliance
-history of recent or chronic steroid medication
-automimmune disease
-inflammatory bowel disease or malabsorptive disease
-liver cirrhosis (CHILD B + C)
-Acitve viral or bacterial disease (e.g. HIV, Hepatitis B or C, Tbc ect. )
-pregnant women or women with childbearing potential without efficient contraception
-history of cancer in the last five years
-need of long-term anticoagulant medication for any reason
-any medication with ingedrient ASS
-GERD

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
to evaluate excess body weight loss after 3 years

Secondary Outcome Measures

Name	Time	Method
1)Safety of operation techniques comparing early (after 1 year) and late (after 2 and 5 years) postoperative complicatons.<br>2)Comparison of number of Adverse Incidents<br>3)Evaluation of postoperative tube dilation in correlation to the performed procedure (quantitative Analysis with MRI after 1 and 3 years)<br>4)B.A.R.O.S. (bariatric Analysis and Reporting Outcome System) questionnaire after 1 and 3 years<br>5)Changes in metabolic syndrome (HbA1c-value, triglycerides, cholesterol in the course until 5 years<br>6)Changes in blood pressures in the course until 5 years<br>