Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB
BiFLux
1 other identifier
interventional
300
1 country
1
Brief Summary
Evaluation of the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2020
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 28, 2035
June 6, 2025
June 1, 2025
15 years
May 25, 2020
June 3, 2025
Conditions
Outcome Measures
Primary Outcomes (24)
Marginal ulcer rates
2 years post surgery
Marginal ulcer rates
5 years post surgery
Assessment of age as risk factor for marginal ulcer development
Age of participants will be measured in years.
2 years post surgery
Assessment of age as risk factor for marginal ulcer development
Age of participants will be measured in years
5 years post surgery
Assessment of gender as risk factor for marginal ulcer development
The association between gender of participants (male/female) and incidence of marginal ulcers will be assessed.
2 years post surgery
Assessment of gender as risk factor for marginal ulcer development
The association between gender of participants (male/female) and incidende of marginal ulcers will be assessed.
5 years post surgery
Assessment of tobacco use as risk factor for marginal ulcer development
It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.
2 years post surgery
Assessment of tobacco use as risk factor for marginal ulcer development
It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.
5 years post surgery
Assessment of alcohol use as risk factor for marginal ulcer development
It will be assessed if the number of participants who report alcohol use correlates with the incidence of marginal ulcers.
2 years post surgery
Assessment of alcohol use as risk factor for marginal ulcer development
It will be assessed if the the number of participants who report alcohol use correlates with the incidence of marginal ulcers.
5 years post surgery
Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development
It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers.
2 years post surgery
Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development
It will be assessed if the number of participants who report NSAID use correlates with the incidence of marginal ulcers.
5 years post surgery
Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development
It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers.
2 years post surgery
Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development
It will be assessed if the number of participants who report immunosuppressive medication usage correlates with the incidence of marginal ulcers.
5 years post surgery
Assessment of Helicobacter pylori as risk factor for marginal ulcer development
It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcers.
2 years post surgery
Assessment of Helicobacter pylori as risk factor for marginal ulcer development
It will be assessed if the incidence of Helicobacter pylori proven by biopsy correlates with the incidence of marginal ulcer.
5 years post surgery
Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development
It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.
2 years post surgery
Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development
It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.
5 years post surgery
Assessment of diabetes mellitus as risk factor for marginal ulcer development
It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.
2 years post surgery
Assessment of diabetes mellitus as risk factor for marginal ulcer development
It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.
5 years post surgery
Assessment of dyslipidemia as risk factor for marginal ulcer development
It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers.
2 years post surgery
Assessment of dyslipidemia as risk factor for marginal ulcer development
It will be assessed if the incidence of dyslipidemia among the participants correlates with the incidence of marginal ulcers.
5 years post surgery
Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development
It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers.
2 years post surgery
Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development
It will be assessed if the incidence of CAD among the participants correlates with the incidence of marginal ulcers.
5 years post surgery
Secondary Outcomes (28)
Total weight loss % (TWL)
2 years post surgery
Total weight loss % (TWL)
5 years post surgery
Excess weight loss % (EWL)
2 years post surgery
Excess weight loss % (EWL)
5 years post surgery
Total BMI loss (TBL)
2 years post surgery
- +23 more secondary outcomes
Study Arms (1)
Patients undergoing OAGB
EXPERIMENTALInterventions
The procedure is performed laparoscopically. The "GIA" stapler divides the stomach at the junction of the body and antrum. An Ewald tube, roughly the diameter of the esophagus, is passed by the anesthetist and held against the lesser curvature. The division of the stomach against the tube is completed, with 5- 6 lines of staples. The division of the stomach is parallel to the lesser curvature and up to the angle of His. A point is selected on the small bowel about 200 cm distal to the ligament of Treitz. The jejunal loop is brought up antecolic, and the Endo-GIA stapler is used to perform the anastomosis between the stomach and the small bowel at this point. The distal end of the gastric tube is anastomosed to the side of the small bowel.
Eligibility Criteria
You may qualify if:
- BMI\> 35 kg/m2
- years of controlled conservative obesity treatment without weight reduction
- patients should give their consent to participate in the study
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Limmattal Hospital
Schlieren, Canton of Zurich, 8952, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 25, 2020
First Posted
June 9, 2020
Study Start
June 1, 2020
Primary Completion (Estimated)
May 28, 2035
Study Completion (Estimated)
May 28, 2035
Last Updated
June 6, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share