Interdisciplinary European Guidelines on metabolic and bariatric surgery.
Martin Fried, Volkan Yumuk, Jean-Michel Oppert...
https://pubmed.ncbi.nlm.nih.gov/24135948/Actively Recruiting
Led by University of Ostrava · Updated on 2025-08-19
80
Participants Needed
2
Research Sites
N/A
Total Duration
Researchers are evaluating two new surgical methods called jejuno-ileal diversion and jejuno-colic diversion to treat obesity and Type 2 Diabetes. These procedures create a bowel-to-bowel connection allowing food to pass through two routes, aiming to mimic the effects of metabolic surgeries like gastric bypass but with fewer risks such as malnutrition or diarrhea. The study is a prospective randomized clinical trial sponsored by the University of Ostrava to assess the safety and effectiveness of these innovative approaches. The surgeries are performed under general anesthesia using a laparoscopic technique. For jejuno-ileal diversion, an anastomosis is created between the jejunum and ileum using a linear stapler, and for jejuno-colic diversion, the connection is made between the jejunum and transverse colon. After surgery, patients will have follow-up visits scheduled frequently during the first weeks and then up to 36 months to monitor health and surgical outcomes. Participants will attend clinic visits at specific intervals to assess medical history, physical health including weight and body measurements, blood work such as glycated hemoglobin levels, and metabolic studies like mixed meal tolerance tests. Imaging studies will also be done before and after surgery to check the surgical connections. The primary outcomes include weight loss and improvements in diabetes-related markers over 36 months, with safety and quality of life also monitored through questionnaires and clinical exams.
CONDITIONS
Small Bowel Diversion
J
Jana Soldánová
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
University of Ostrava
Lead Sponsor
Institute for Clinical and Experimental Medicine
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Day of surgery and immediate recovery period
Participants undergo laparoscopic jejuno-ileal or jejuno-colic diversion surgery under general anesthesia. This involves creating an anastomosis between parts of the small intestine or between the jejunum and transverse colon.
1 visit (in-person) for surgery
Duration - Up to 36 months after surgery
Participants have follow-up clinic visits to monitor recovery, assess adverse events, and conduct physical exams including weight and girth measurements. Blood work such as glycated hemoglobin (HbA1c) is also performed.
Follow-up visits at weeks 1, 2, 3 and months 1, 2, 3, 6, 12, 18, 24, 30, and 36 after surgery
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Martin Fried, Volkan Yumuk, Jean-Michel Oppert...
https://pubmed.ncbi.nlm.nih.gov/24135948/Su-Hsin Chang, Carolyn R T Stoll, Jihyun Song...
https://pubmed.ncbi.nlm.nih.gov/24352617/Henry Buchwald, Yoav Avidor, Eugene Braunwald...
https://pubmed.ncbi.nlm.nih.gov/15479938/Francesco Rubino, Michel Gagner
https://pubmed.ncbi.nlm.nih.gov/12409659/Judith Korner, William Inabnet, Irene M Conwell...
https://pubmed.ncbi.nlm.nih.gov/17030966/Francesco Rubino, Michel Gagner, Paolo Gentileschi...
https://pubmed.ncbi.nlm.nih.gov/15273546/Lars Sjöström, Kristina Narbro, C David Sjöström...
https://pubmed.ncbi.nlm.nih.gov/17715408/Sarah Catherine Walpole, David Prieto-Merino, Phil Edwards...
https://pubmed.ncbi.nlm.nih.gov/22709383/Francesco Rubino, David M Nathan, Robert H Eckel...
https://pubmed.ncbi.nlm.nih.gov/27957699/N Honzíková, A Krtička, E Závodná...
https://pubmed.ncbi.nlm.nih.gov/22670692/University of Ostrava
Lead Sponsor
Institute for Clinical and Experimental Medicine
Collaborating Sponsor