ClinicalTrials.gg
RecruitingNCT04422405BiFLuxUpdated Jun 6, 2025

Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB

An interventional study of One Anastomosis Gastric Bypass (OAGB) in Obesity, Morbid, GERD and Ulcer, Gastric, sponsored by Spital Limmattal Schlieren. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-06-06.

Sponsored by Spital Limmattal Schlieren · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2020; still recruiting 6 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Evaluation of the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB)

02

Conditions studied

  • Obesity, Morbid
  • GERD
  • Ulcer, Gastric
03

In context

Obesity, Morbid

941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.

This study's planned enrollment of 300 is above the median of 62 across 602 interventional studies indexed under Obesity, Morbid.

Browse Obesity, Morbid studies →

Lead sponsor

Spital Limmattal Schlieren is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • > 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

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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Patients undergoing OAGB

    Procedure: One Anastomosis Gastric Bypass (OAGB)

Interventions

  • ProcedureOne Anastomosis Gastric Bypass (OAGB)

    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.

    Also known as: Mini-Gastric Bypass

06

What researchers measure

Primary outcomes

  1. Marginal ulcer rates

    Time frame: 2 years post surgery

  2. Marginal ulcer rates

    Time frame: 5 years post surgery

  3. Assessment of age as risk factor for marginal ulcer development

    Age of participants will be measured in years.

    Time frame: 2 years post surgery

  4. Assessment of age as risk factor for marginal ulcer development

    Age of participants will be measured in years

    Time frame: 5 years post surgery

  5. 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.

    Time frame: 2 years post surgery

  6. 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.

    Time frame: 5 years post surgery

  7. 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.

    Time frame: 2 years post surgery

  8. 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.

    Time frame: 5 years post surgery

  9. 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.

    Time frame: 2 years post surgery

  10. 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.

    Time frame: 5 years post surgery

  11. 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.

    Time frame: 2 years post surgery

  12. 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.

    Time frame: 5 years post surgery

  13. 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.

    Time frame: 2 years post surgery

  14. 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.

    Time frame: 5 years post surgery

  15. 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.

    Time frame: 2 years post surgery

  16. 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.

    Time frame: 5 years post surgery

  17. 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.

    Time frame: 2 years post surgery

  18. 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.

    Time frame: 5 years post surgery

  19. 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.

    Time frame: 2 years post surgery

  20. 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.

    Time frame: 5 years post surgery

  21. 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.

    Time frame: 2 years post surgery

  22. 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.

    Time frame: 5 years post surgery

  23. 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.

    Time frame: 2 years post surgery

  24. 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.

    Time frame: 5 years post surgery

Secondary outcomes

  1. Total weight loss % (TWL)

    Time frame: 2 years post surgery

  2. Total weight loss % (TWL)

    Time frame: 5 years post surgery

  3. Excess weight loss % (EWL)

    Time frame: 2 years post surgery

  4. Excess weight loss % (EWL)

    Time frame: 5 years post surgery

  5. Total BMI loss (TBL)

    Time frame: 2 years post surgery

  6. Total BMI loss (TBL)

    Time frame: 5 years post surgery

  7. Excess BMI loss (EBL)

    Time frame: 2 years post surgery

  8. Excess BMI loss (EBL)

    Time frame: 5 years post surgery

  9. Late morbidity (>30 days)

    Number of surgical complications according to Dindo-Clavien classification

    Time frame: 30 days post surgery

  10. Late morbidity (>30 days)

    Number of surgical complications according to Dindo-Clavien classification

    Time frame: 5 years

  11. Incidence of gastroesopagheal reflux disease (GERD)

    based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification

    Time frame: 2 years post surgery

  12. Incidence of gastroesopagheal reflux disease (GERD)

    based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification

    Time frame: 5 years post surgery

  13. Incidence of Barrett's esophagus

    based on biopsy findings

    Time frame: 2 years post surgery

  14. Incidence of Barrett's esophagus

    based on biopsy findings

    Time frame: 5 years post surgery

  15. Changes of esophageal motor function

    The esophageal motor function will be measured in mmHg via high-resolution manometry.

    Time frame: 2 years post surgery

  16. Changes of esophageal motor function

    The esophageal motor function will be measured in mmHg via high-resolution manometry.

    Time frame: 5 years post surgery

  17. Esophageal acid or bolus exposure

    Measured with impedance-pH Monitoring. Acid exposure (%) is defined as the total time the pH is \< 4 divided by the time monitored. Bolus exposure (%) is defined as being analogous to acid exposure by adding the duration of all four reflux subcategories defined by the impedance, and dividing this value by the time monitored.

    Time frame: 2 years post surgery

  18. Esophageal acid or bolus exposure

    Measured with impedance-pH Monitoring. Acid exposure (%) is defined as the total time the pH is \< 4 divided by the time monitored. Bolus exposure (%) is defined as being analogous to acid exposure by adding the duration of all four reflux subcategories defined by the impedance, and dividing this value by the time monitored.

    Time frame: 5 years post surgery

  19. Number of acid or alcaline reflux events

    Measured with impedance-pH Monitoring.

    Time frame: 2 years post surgery

  20. Number of acid or alcaline reflux events

    Measured with impedance-pH Monitoring.

    Time frame: 5 years post surgery

  21. Gastrointestinal quality of life (QoL): GIQLI

    The gastrointestinal (QoL) will be measured using the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a validated tool to assess health- related quality of life of patients with gastrointestinal disease or patients who undergo gastrointestinal operations. Its scale is 0-128. Higher values indicate a better quality of life outcome.

    Time frame: 2 years post surgery

  22. Gastrointestinal quality of life (QoL): GIQLI

    The gastrointestinal (QoL) will be measured using the Gastrointestinal Quality of Life Index (GIQLI). The GIQLI is a validated tool to assess health- related quality of life of patients with gastrointestinal disease or patients who undergo gastrointestinal operations. Its scale is 0-128. Higher values indicate a better quality of life outcome.

    Time frame: 5 years post surgery

  23. Obesity- related quality of life (QoL): BAROS

    Obesity- related QoL will be measured with the BAROS (Bariatric Analysis and Reporting Outcome System). BAROS consists of a scoring table that includes three columns with the main areas of interest: weight loss, improvement of medical conditions, and QoL. A maximum of three points is given in each domain to evaluate changes after medical intervention (maximum score is 9 points). Higher scores indicate a better outcome.

    Time frame: 2 years post surgery

  24. Obesity- related quality of life: BAROS

    Obesity- related QoL will be measured with the BAROS (Bariatric Analysis and Reporting Outcome System). BAROS consists of a scoring table that includes three columns with the main areas of interest: weight loss, improvement of medical conditions, and QoL. A maximum of three points is given in each domain to evaluate changes after medical intervention (maximum score is 9 points). Higher scores indicate a better outcome.

    Time frame: 5 years post surgery

  25. Reflux-associated symptoms

    GERD symptoms will be measured with the Gastroesophageal reflux disease questionnaire (GERDQ). GERDQ has a scale between 0 and 18 points. Increasing scores correlate with increasing severity of heartburn symptoms.

    Time frame: 2 years post surgery

  26. Reflux-associated symptoms

    GERD symptoms will be measured with the Gastroesophageal reflux disease questionnaire (GERDQ). GERDQ has a scale between 0 and 18 points. Increasing scores correlate with increasing severity of heartburn symptoms.

    Time frame: 5 years post surgery

  27. Reflux-associated quality of life (QoL): GERD-HRQL

    Reflux- associated QoL will be assessed with the Health-related QoL scale for GERD (GERD-HRQL). The scale has 11 items, which focus on heartburn symptoms, dysphagia, medication effects and the patient's present health condition. Each item is scored from 0 to 5, with a higher score indicating a better QoL.

    Time frame: 2 years post surgery

  28. Reflux-associated quality of life (QoL): GERD-HRQL

    Reflux- associated QoL will be assessed with the Health-related QoL scale for GERD (GERD-HRQL). The scale has 11 items, which focus on heartburn symptoms, dysphagia, medication effects and the patient's present health condition. Each item is scored from 0 to 5, with a higher score indicating a better QoL.

    Time frame: 5 years post surgery

07

Study locations

1 of 1 sites recruiting
  • Limmattal Hospital
    Schlieren, Zurich 8952, Switzerland
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04422405
Lead sponsor
Spital Limmattal Schlieren
Responsible party
Marko Kraljevic, MD (Principal Investigator, Spital Limmattal Schlieren) — Principal investigator
First posted
Jun 9, 2020
Start date
Jun 1, 2020
Primary completion
May 28, 2035 (estimated)
Completion
May 28, 2035 (estimated)
Last update
Jun 6, 2025

Study contacts

Urs Zingg, MD, Prof.
Contact
urs.zingg@spital-limmattal.ch
+41 44 733 21 26

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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