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

Obesity, Morbid Clinical Trial

— BiFLux  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04422405
• Other study ID #: SLS-003
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: May 28, 2028

Study information

• Verified date: October 2020
• Source: Spital Limmattal Schlieren
• Contact: Urs Zingg, MD, Prof.
• Phone: +41 44 733 21 26
• Email: urs.zingg[@]spital-limmattal.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 28, 2028
• Est. primary completion date: May 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• GERD
• Obesity, Morbid
• Stomach Ulcer
• Ulcer, Gastric

Intervention

Procedure:
• One 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.

Locations

Country	Name	City	State
Switzerland	Limmattal Hospital	Schlieren	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Spital Limmattal Schlieren

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal ulcer rates		2 years post surgery
Primary	Marginal ulcer rates		5 years post surgery
Primary	Assessment of age as risk factor for marginal ulcer development	Age of participants will be measured in years.	2 years post surgery
Primary	Assessment of age as risk factor for marginal ulcer development	Age of participants will be measured in years	5 years post surgery
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Total weight loss % (TWL)		2 years post surgery
Secondary	Total weight loss % (TWL)		5 years post surgery
Secondary	Excess weight loss % (EWL)		2 years post surgery
Secondary	Excess weight loss % (EWL)		5 years post surgery
Secondary	Total BMI loss (TBL)		2 years post surgery
Secondary	Total BMI loss (TBL)		5 years post surgery
Secondary	Excess BMI loss (EBL)		2 years post surgery
Secondary	Excess BMI loss (EBL)		5 years post surgery
Secondary	Late morbidity (>30 days)	Number of surgical complications according to Dindo-Clavien classification	30 days post surgery
Secondary	Late morbidity (>30 days)	Number of surgical complications according to Dindo-Clavien classification	5 years
Secondary	Incidence of gastroesopagheal reflux disease (GERD)	based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification	2 years post surgery
Secondary	Incidence of gastroesopagheal reflux disease (GERD)	based on upper gastrointestinal endoscopy findings and classified according to the Los Angeles Classification	5 years post surgery
Secondary	Incidence of Barrett's esophagus	based on biopsy findings	2 years post surgery
Secondary	Incidence of Barrett's esophagus	based on biopsy findings	5 years post surgery
Secondary	Changes of esophageal motor function	The esophageal motor function will be measured in mmHg via high-resolution manometry.	2 years post surgery
Secondary	Changes of esophageal motor function	The esophageal motor function will be measured in mmHg via high-resolution manometry.	5 years post surgery
Secondary	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.	2 years post surgery
Secondary	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.	5 years post surgery
Secondary	Number of acid or alcaline reflux events	Measured with impedance-pH Monitoring.	2 years post surgery
Secondary	Number of acid or alcaline reflux events	Measured with impedance-pH Monitoring.	5 years post surgery
Secondary	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.	2 years post surgery
Secondary	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.	5 years post surgery
Secondary	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.	2 years post surgery
Secondary	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.	5 years post surgery
Secondary	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.	2 years post surgery
Secondary	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.	5 years post surgery
Secondary	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.	2 years post surgery
Secondary	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.	5 years post surgery