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

NCT ID: NCT04422405

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2035-05-28

Brief Summary

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

Detailed Description

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Conditions

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Obesity, Morbid GERD Ulcer, Gastric

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients undergoing OAGB

Group Type EXPERIMENTAL

One Anastomosis Gastric Bypass (OAGB)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Mini-Gastric Bypass

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spital Limmattal Schlieren

OTHER

Sponsor Role lead

Responsible Party

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Marko Kraljevic, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Limmattal Hospital

Schlieren, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Urs Zingg, MD, Prof.

Role: CONTACT

+41 44 733 21 26

Facility Contacts

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Urs Zingg, Prof.

Role: primary

+41 44 733 21 26

Other Identifiers

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SLS-003

Identifier Type: -

Identifier Source: org_study_id

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