Evaluation of the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
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.
Limmattal Hospital
Schlieren, Canton of Zurich, Switzerland
RECRUITINGMarginal ulcer rates
Time frame: 2 years post surgery
Marginal ulcer rates
Time frame: 5 years post surgery
Assessment of age as risk factor for marginal ulcer development
Age of participants will be measured in years.
Time frame: 2 years post surgery
Assessment of age as risk factor for marginal ulcer development
Age of participants will be measured in years
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years post surgery
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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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Total weight loss % (TWL)
Time frame: 2 years post surgery
Total weight loss % (TWL)
Time frame: 5 years post surgery
Excess weight loss % (EWL)
Time frame: 2 years post surgery
Excess weight loss % (EWL)
Time frame: 5 years post surgery
Total BMI loss (TBL)
Time frame: 2 years post surgery
Total BMI loss (TBL)
Time frame: 5 years post surgery
Excess BMI loss (EBL)
Time frame: 2 years post surgery
Excess BMI loss (EBL)
Time frame: 5 years post surgery
Late morbidity (>30 days)
Number of surgical complications according to Dindo-Clavien classification
Time frame: 30 days post surgery
Late morbidity (>30 days)
Number of surgical complications according to Dindo-Clavien classification
Time frame: 5 years
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
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
Incidence of Barrett's esophagus
based on biopsy findings
Time frame: 2 years post surgery
Incidence of Barrett's esophagus
based on biopsy findings
Time frame: 5 years post surgery
Changes of esophageal motor function
The esophageal motor function will be measured in mmHg via high-resolution manometry.
Time frame: 2 years post surgery
Changes of esophageal motor function
The esophageal motor function will be measured in mmHg via high-resolution manometry.
Time frame: 5 years post surgery
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
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
Number of acid or alcaline reflux events
Measured with impedance-pH Monitoring.
Time frame: 2 years post surgery
Number of acid or alcaline reflux events
Measured with impedance-pH Monitoring.
Time frame: 5 years post surgery
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
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
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
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
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
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
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
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