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Search / Trial NCT03097887

Omega Loop Gastric Bypass With And Without Anti-Reflux Sutures

Launched by MEDICAL UNIVERSITY OF VIENNA · Mar 25, 2017

Trial Information

Current as of April 30, 2025

Unknown status

Keywords

Omega Loop Gastric Bypass Reflux Mini Gastric Bypass

ClinConnect Summary

Obesity, and especially its comorbidities, has unarguably become the number one threat to human health in the modern world. Western lifestyle leads to an increased prevalence and thus to a higher mortality (i.e. due to cardiovascular diseases).

The positive effects of gastric bypass surgery on excess weight loss and comorbidity resolution are well-known. In contrast to the standard laparoscopic Roux-en-Y Gastric Bypass (RYGB), a newer method, the laparoscopic Omega Loop Gastric Bypass (OLGB), has emerged over the past years. It is believed to be the simpler method involving only one anasto...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age between 20 and 70 years
  • Body Mass Index ≥ 35.0 kg/m2
  • Exclusion of psychological, endocrinological and anesthesiological contraindications
  • Willingness to be assigned to either of the two groups
  • Follow-up anticipation
  • Willingness to attend all follow-up visits
  • Written informed consent
  • Exclusion Criteria:
  • recent or ongoing cardiovascular event within the last 6 months (myocardial infarction, acute coronary syndrome, angioplasty or coronary bypass operation, insult),
  • pulmonary embolism or thrombophlebitis within the last 6 months, other bariatric procedures, e.g. gastric banding, Sleeve Gastrectomy, etc., cancer of various origins (exceptions: basal cell carcinoma or carcinoma in situ, disease-free over the last 5 years),
  • significant anemia or coagulopathy,
  • serum creatinin ≥ 1.5 mg/dl.,
  • serum bilirubin or phosphatase elevated or ALT above 3 times the upper limit, stomach, biliopancreatic operations, splenectomy or colon resections, gastric or duodenal ulcer within the last 6 months,
  • intraabdominal sepsis (except uncomplicated appendicitis or diverticulitis over 6 months prior to the study),
  • organ transplantations,
  • anamnestic HIV infection, active TBC, active malaria, chronic Hepatitis B or C, liver cirrhosis,
  • alcohol or drug addiction (except caffeine, nicotine) in history,
  • acute psychiatric disease interfering with the proposed trial,
  • other chronic disease which might interfere with the participation.
  • Also, patients who are pregnant or plan a pregnancy within the following two years as well as patients who have been included in another study, will be excluded.
  • Note: Exclusion can be performed by a study coordinator at any time.
  • Hiatal hernia is not considered an exclusion criterion in this study.

About Medical University Of Vienna

The Medical University of Vienna is a leading research institution dedicated to advancing healthcare through innovative clinical research and education. Renowned for its commitment to excellence in medical science, the university fosters interdisciplinary collaboration among researchers, clinicians, and academic professionals. Its clinical trials encompass a wide range of medical disciplines, aiming to develop cutting-edge therapies and improve patient outcomes. With state-of-the-art facilities and a strong emphasis on ethical standards, the Medical University of Vienna is at the forefront of transforming scientific discoveries into practical applications that enhance global health.

Locations

Wien, Vienna, Austria

Patients applied

0 patients applied

Trial Officials

Gerhard Prager, Univ. Prof.

Study Director

Vienna Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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