Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT04422405

Recruiting nowNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Morbid, GERD, Ulcer, Gastric

Full registry 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)

Treatments and study arms

One Anastomosis Gastric Bypass (OAGB)

Procedure

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 outcomes

Marginal ulcer rates2 years post surgery

Marginal ulcer rates5 years post surgery

Assessment of age as risk factor for marginal ulcer development2 years post surgery

Age of participants will be measured in years.

Assessment of age as risk factor for marginal ulcer development5 years post surgery

Age of participants will be measured in years

Assessment of gender as risk factor for marginal ulcer development2 years post surgery

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 development5 years post surgery

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 development2 years post surgery

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 development5 years post surgery

It will be assessed if the number of participants who are smokers correlates with the incidence of marginal ulcers.

Study locations

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Limmattal Hospital🇨🇭 Schlieren, Canton of Zurich, Switzerland

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Urs Zingg, Prof.Contact

Email · Call +41 44 733 21 26