A new surgical approach to reduce GERD after weight loss surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates a modified vertical sleeve gastrectomy (mVSG) to determine its effectiveness in reducing gastroesophageal reflux disease (GERD) compared to conventional vertical sleeve gastrectomy (cVSG). The study will measure acid exposure time (AET) using the Bravo pH test at 6-9 months post-surgery, alongside various mechanistic assessments such as esophageal manometry and endoluminal imaging. Additionally, the impact of GERD on quality of life will be evaluated using validated rating scales. The trial aims to provide insights into both clinical and mechanistic outcomes associated with this innovative surgical technique.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male and female subjects aged 18-65 years
2. Body mass index (BMI) 35-55 kg/m2
3. Must meet the BMI criteria before and after 6 months of nonsurgical weight management
4. Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test.
5. Have health insurance which pays for the costs of bariatric surgery and standard medical care before and after surgery
6. Women of childbearing potential must be using appropriate contraception to avoid pregnancy throughout the study, and must have a negative pregnancy test at study entry and prior to surgery
7. Must be able to provide written informed consent

Exclusion Criteria:

1. Hiatal hernia \>2cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at the time of surgery)
2. Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator
3. Severe gastroparesis
4. Previous bariatric or anti-reflux procedure
5. Barrett's esophagus
6. Subjects requiring mesh treatment at time of procedure
7. Severe heart (e.g., severe heart failure, unstable coronary artery disease), or end-stage lung disease as determined by the site primary investigator
8. Subjects with pacemakers, implantable defibrillators, neurostimulators
9. Portal hypertension or cirrhosis
10. Chronic pancreatitis
11. Active cancer treatment
12. Inability to tolerate general anesthesia
13. Uncontrollable coagulopathy
14. Significant and uncontrolled inflammatory bowel disease
15. Severe and/or uncontrolled psychiatric disorder (including psychosis, bipolar disorder) as determined during standard pre-surgery psychiatric screening at the site.
16. Suicidal ideation or unstable/untreated major depressive disorder within the past year
17. Alcohol or substance use disorder within the past year.
18. Pregnant or breastfeeding or planning pregnancy in the coming 24 months
19. Diminished intellectual capacity to consent or follow pre- and post-surgery instructions
20. History of, or any current health condition that, in the opinion of the PI, would make the subject ineligible for sleeve gastrectomy, or put the subject at risk by participation in the study.

Where it's running

• University of California, Irvine
  Orange, California, United States Recruiting
• University of California, San Diego
  San Diego, California, United States Recruiting

Study contacts

• Principal investigator: Ninh T. Nguyen, MD — University of California, Irvine
• Study coordinator: Ninh T. Nguyen, MD
• Email: ninhn@hs.uci.edu
• Phone: 714 456 8598

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Extra daily iron after sleeve gastrectomy to prevent anemia

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• Digestion and gut function after bariatric surgery

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• Preoperative IV ferric derisomaltose to prevent anemia and improve quality of life in obese patients having bariatric surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.