Evaluating stomach and esophagus changes after gastric bypass surgery
Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Spital Limmattal Schlieren Academic / other |
| Locations | 1 site (Schlieren, Canton of Zurich) |
| Trial ID | NCT04422405 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While there may be studies on gastric bypass, the specific focus on functional changes post-OAGB is relatively novel and not extensively tested.
Eligibility criteria
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 this trial is running
Schlieren, Canton of Zurich
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.