Evaluating stomach and esophagus changes after gastric bypass surgery
Official title: Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial
Run by Spital Limmattal Schlieren · NCT04422405 · Data updated 2026-11-12
This study is testing how gastric bypass surgery affects the stomach and esophagus in people with obesity who haven't lost weight through other methods.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Spital Limmattal Schlieren Academic / other |
| Locations | 1 site (Schlieren, Canton of Zurich) |
| Status | Recruiting |
| Started | June 1, 2020 |
| Main results expected | May 28, 2035 |
| Study ends | May 28, 2035 |
| Registry record updated | June 6, 2025 |
| Trial ID | NCT04422405 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals with a BMI over 35 kg/m2 who have undergone at least two years of conservative obesity treatment without significant weight loss.
✕Probably not a fit
Patients with certain gastrointestinal disorders, severe psychiatric conditions, or those who have not met the conservative treatment criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the functional changes in the stomach and esophagus of patients who undergo One Anastomosis Gastric Bypass (OAGB). It aims to assess how this surgical intervention affects gastrointestinal function, particularly in patients with obesity and related conditions. The study will involve patients with a BMI greater than 35 kg/m2 who have not achieved weight reduction through conservative treatment over the past two years. Participants will be monitored for various gastrointestinal parameters post-surgery.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of OAGB in improving gastrointestinal function and managing obesity-related conditions.
How similar studies have gone: While there may be studies on gastric bypass, the specific focus on functional changes post-OAGB is relatively novel and not extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI\> 35 kg/m2 * 2 years of controlled conservative obesity treatment without weight reduction * patients should give their consent to participate in the study Exclusion Criteria: * Less than 2 years of conservative obesity treatment * cancer * cirrhosis Child-Pough score A * Crohn's disease * serious psychiatric disorder, which led to in-hospital treatment in psychiatric clinic in the past two years * drug consumption * non-compliance * hiatal hernia \> 4cm * gastric pouch \< 10cm * Barett esophagus * erosive esophagitis Grade C or D according to the Los Angeles Classification * endoscopically proven gastric stricture * acid exposition time \> 6% (Lyon criteria) * reflux episodes\> 80 /24 hours (Lyon criteria) * insufficient low esophageal sphincter according to manometry findings * pathological findings in the impedance pH-metry (acid and non-acid reflux)
Where it's running
-
Limmattal Hospital
Schlieren, Canton of Zurich, Switzerland Recruiting
Study contacts
- Study coordinator: Urs Zingg, MD, Prof.
- Email: urs.zingg@spital-limmattal.ch
- Phone: +41 44 733 21 26
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.