RecruitingNot Applicable

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

Switzerland300 participantsStarted 2020-06-01

Plain-language summary

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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Marginal ulcer rates

Timeframe: 2 years post surgery

Marginal ulcer rates

Timeframe: 5 years post surgery

Assessment of age as risk factor for marginal ulcer development

Timeframe: 2 years post surgery

Assessment of age as risk factor for marginal ulcer development

Timeframe: 5 years post surgery

Assessment of gender as risk factor for marginal ulcer development

Timeframe: 2 years post surgery

Assessment of gender as risk factor for marginal ulcer development

Timeframe: 5 years post surgery

Assessment of tobacco use as risk factor for marginal ulcer development

Timeframe: 2 years post surgery

Trial details

NCT IDNCT04422405

SponsorSpital Limmattal Schlieren

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2035-05-28

Contact for this trial

Urs Zingg, MD, Prof.

+41 44 733 21 26 urs.zingg@spital-limmattal.ch

View on ClinicalTrials.gov More Obesity, Morbid trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Marginal ulcer rates

Timeframe: 2 years post surgery

Marginal ulcer rates

Timeframe: 5 years post surgery

Assessment of age as risk factor for marginal ulcer development

Timeframe: 2 years post surgery

Assessment of age as risk factor for marginal ulcer development

Timeframe: 5 years post surgery

Assessment of gender as risk factor for marginal ulcer development

Timeframe: 2 years post surgery

Assessment of gender as risk factor for marginal ulcer development

Timeframe: 5 years post surgery

Assessment of tobacco use as risk factor for marginal ulcer development

Timeframe: 2 years post surgery