search
Back to results

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

Primary Purpose

Obesity, Morbid, GERD, Ulcer, Gastric

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
One Anastomosis Gastric Bypass (OAGB)
Sponsored by
Spital Limmattal Schlieren
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Limmattal HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients undergoing OAGB

Arm Description

Outcomes

Primary Outcome Measures

Marginal ulcer rates
Marginal ulcer rates
Assessment of age as risk factor for marginal ulcer development
Age of participants will be measured in years.
Assessment of age as risk factor for marginal ulcer development
Age of participants will be measured in years
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Total weight loss % (TWL)
Total weight loss % (TWL)
Excess weight loss % (EWL)
Excess weight loss % (EWL)
Total BMI loss (TBL)
Total BMI loss (TBL)
Excess BMI loss (EBL)
Excess BMI loss (EBL)
Late morbidity (>30 days)
Number of surgical complications according to Dindo-Clavien classification
Late morbidity (>30 days)
Number of surgical complications according to Dindo-Clavien classification
Incidence of gastroesopagheal reflux disease (GERD)
based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification
Incidence of gastroesopagheal reflux disease (GERD)
based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification
Incidence of Barrett's esophagus
based on biopsy findings
Incidence of Barrett's esophagus
based on biopsy findings
Changes of esophageal motor function
The esophageal motor function will be measured in mmHg via high-resolution manometry.
Changes of esophageal motor function
The esophageal motor function will be measured in mmHg via high-resolution manometry.
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.
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.
Number of acid or alcaline reflux events
Measured with impedance-pH Monitoring.
Number of acid or alcaline reflux events
Measured with impedance-pH Monitoring.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 25, 2020
Last Updated
October 20, 2020
Sponsor
Spital Limmattal Schlieren
search

1. Study Identification

Unique Protocol Identification Number
NCT04422405
Brief Title
Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB
Acronym
BiFLux
Official Title
Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB- BiFlux Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
May 28, 2023 (Anticipated)
Study Completion Date
May 28, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spital Limmattal Schlieren

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, GERD, Ulcer, Gastric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients undergoing OAGB
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
One Anastomosis Gastric Bypass (OAGB)
Other Intervention Name(s)
Mini-Gastric Bypass
Intervention Description
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.
Primary Outcome Measure Information:
Title
Marginal ulcer rates
Time Frame
2 years post surgery
Title
Marginal ulcer rates
Time Frame
5 years post surgery
Title
Assessment of age as risk factor for marginal ulcer development
Description
Age of participants will be measured in years.
Time Frame
2 years post surgery
Title
Assessment of age as risk factor for marginal ulcer development
Description
Age of participants will be measured in years
Time Frame
5 years post surgery
Title
Assessment of gender as risk factor for marginal ulcer development
Description
The association between gender of participants (male/female) and incidence of marginal ulcers will be assessed.
Time Frame
2 years post surgery
Title
Assessment of gender as risk factor for marginal ulcer development
Description
The association between gender of participants (male/female) and incidende of marginal ulcers will be assessed.
Time Frame
5 years post surgery
Title
Assessment of tobacco use as risk factor for marginal ulcer development
Description
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
Title
Assessment of tobacco use as risk factor for marginal ulcer development
Description
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
Title
Assessment of alcohol use as risk factor for marginal ulcer development
Description
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
Title
Assessment of alcohol use as risk factor for marginal ulcer development
Description
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
Title
Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development
Description
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
Title
Assessment of nonsteroidal antiinflammatory drug (NSAID) use as risk factor for marginal ulcer development
Description
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
Title
Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development
Description
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
Title
Assessment of immunosuppressive medication usage as risk factor for marginal ulcer development
Description
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
Title
Assessment of Helicobacter pylori as risk factor for marginal ulcer development
Description
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
Title
Assessment of Helicobacter pylori as risk factor for marginal ulcer development
Description
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
Title
Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development
Description
It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.
Time Frame
2 years post surgery
Title
Assessment of gastroesophageal reflux disease (GERD) as risk factor for marginal ulcer development
Description
It will be assessed if the incidence of GERD correlates with the incidence of marginal ulcers.
Time Frame
5 years post surgery
Title
Assessment of diabetes mellitus as risk factor for marginal ulcer development
Description
It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.
Time Frame
2 years post surgery
Title
Assessment of diabetes mellitus as risk factor for marginal ulcer development
Description
It will be assessed if the incidence of diabetes mellitus correlates with the incidence of marginal ulcers.
Time Frame
5 years post surgery
Title
Assessment of dyslipidemia as risk factor for marginal ulcer development
Description
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
Title
Assessment of dyslipidemia as risk factor for marginal ulcer development
Description
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
Title
Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development
Description
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
Title
Assessment of coronary artery disease (CAD) as risk factor for marginal ulcer development
Description
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 Outcome Measure Information:
Title
Total weight loss % (TWL)
Time Frame
2 years post surgery
Title
Total weight loss % (TWL)
Time Frame
5 years post surgery
Title
Excess weight loss % (EWL)
Time Frame
2 years post surgery
Title
Excess weight loss % (EWL)
Time Frame
5 years post surgery
Title
Total BMI loss (TBL)
Time Frame
2 years post surgery
Title
Total BMI loss (TBL)
Time Frame
5 years post surgery
Title
Excess BMI loss (EBL)
Time Frame
2 years post surgery
Title
Excess BMI loss (EBL)
Time Frame
5 years post surgery
Title
Late morbidity (>30 days)
Description
Number of surgical complications according to Dindo-Clavien classification
Time Frame
30 days post surgery
Title
Late morbidity (>30 days)
Description
Number of surgical complications according to Dindo-Clavien classification
Time Frame
5 years
Title
Incidence of gastroesopagheal reflux disease (GERD)
Description
based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification
Time Frame
2 years post surgery
Title
Incidence of gastroesopagheal reflux disease (GERD)
Description
based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification
Time Frame
5 years post surgery
Title
Incidence of Barrett's esophagus
Description
based on biopsy findings
Time Frame
2 years post surgery
Title
Incidence of Barrett's esophagus
Description
based on biopsy findings
Time Frame
5 years post surgery
Title
Changes of esophageal motor function
Description
The esophageal motor function will be measured in mmHg via high-resolution manometry.
Time Frame
2 years post surgery
Title
Changes of esophageal motor function
Description
The esophageal motor function will be measured in mmHg via high-resolution manometry.
Time Frame
5 years post surgery
Title
Esophageal acid or bolus exposure
Description
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
Title
Esophageal acid or bolus exposure
Description
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
Title
Number of acid or alcaline reflux events
Description
Measured with impedance-pH Monitoring.
Time Frame
2 years post surgery
Title
Number of acid or alcaline reflux events
Description
Measured with impedance-pH Monitoring.
Time Frame
5 years post surgery
Title
Gastrointestinal quality of life (QoL): GIQLI
Description
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
Title
Gastrointestinal quality of life (QoL): GIQLI
Description
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
Title
Obesity- related quality of life (QoL): BAROS
Description
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
Title
Obesity- related quality of life: BAROS
Description
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
Title
Reflux-associated symptoms
Description
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
Title
Reflux-associated symptoms
Description
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
Title
Reflux-associated quality of life (QoL): GERD-HRQL
Description
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
Title
Reflux-associated quality of life (QoL): GERD-HRQL
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Urs Zingg, MD, Prof.
Phone
+41 44 733 21 26
Email
urs.zingg@spital-limmattal.ch
Facility Information:
Facility Name
Limmattal Hospital
City
Schlieren
State/Province
Zurich
ZIP/Postal Code
8952
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urs Zingg, Prof.
Phone
+41 44 733 21 26
Email
urs.zingg@spital-limmattal.ch

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs