Actively Recruiting
Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial
Led by Spital Limmattal Schlieren · Updated on 2025-06-06
300
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB). This study aims to assess various risk factors such as age, gender, tobacco and alcohol use, medications, and health conditions for the development of marginal ulcers after surgery, as well as other outcomes related to weight loss and gastrointestinal health. The research is sponsored by Spital Limmattal Schlieren and focuses on patients with obesity and related conditions like GERD and gastric ulcers. Participants will undergo the OAGB procedure performed laparoscopically. The surgery involves dividing the stomach and connecting it to the small bowel at a point about 200 cm from the ligament of Treitz. This creates a new pathway for food to bypass part of the stomach and small intestine. The study tracks patients after surgery to monitor changes and complications over time. Throughout the study, participants will be followed for up to 5 years post-surgery. Researchers will monitor marginal ulcer rates, weight loss percentages, changes in esophageal function, reflux events, and quality of life related to gastrointestinal and obesity issues. Assessments include endoscopy, manometry, impedance pH-metry, and questionnaires to evaluate reflux symptoms and life quality. Safety and long-term effects will be carefully observed to understand the impact of OAGB on stomach and esophagus function.
CONDITIONS
Brief Title
Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI greater than 35 kg/m2
- At least 2 years of controlled conservative obesity treatment without weight reduction
- Patients must give consent to participate in the study
You will not qualify if you...
- Less than 2 years of conservative obesity treatment
- Cancer
- Cirrhosis Child-Pough score A
- Crohn's disease
- Serious psychiatric disorder leading to hospital treatment in the past 2 years
- Drug consumption
- Non-compliance
- Hiatal hernia larger than 4cm
- Gastric pouch smaller than 10cm
- Barrett esophagus
- Erosive esophagitis Grade C or D
- Endoscopically proven gastric stricture
- Acid exposure time over 6% (Lyon criteria)
- Reflux episodes over 80 per 24 hours (Lyon criteria)
- Insufficient low esophageal sphincter by manometry
- Pathological findings in impedance pH-metry (acid and non-acid reflux)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until discharge
Participants undergo the One Anastomosis Gastric Bypass (OAGB) surgery performed laparoscopically, followed by immediate post-operative care.
1 surgery visit and several immediate post-operative visits
Duration - Up to 5 years post surgery
Participants are monitored for recovery, functional changes in the stomach and esophagus, and assessed for complications and quality of life outcomes over time.
Periodic follow-up visits over 5 years
Trial Site Locations
Total: 1 location
1
Limmattal Hospital
Schlieren, Canton of Zurich, Switzerland, 8952
Actively Recruiting
Research Team
U
Urs Zingg, MD, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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