Banded Versus Conventional Laparoscopic Sleeve Gastrectomy

Banded Versus Conventional Laparoscopic Sleeve Gastrectomy - RIGA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000809

Enrollment

Registered

2011-04-14

Start date

2011-04-13

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E66

Interventions

Group 1: conventional sleeve gastrectomy Group 2: banded sleeve gastrectomy

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
to evaluate excess body weight loss after 3 years	—

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactOlivia Sick

Universitätsklinikum Freiburg Abteilung Allgemein- und Viszeralchirurgie

olivia.sick@uniklinik-freiburg.de0761/270-2808

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026