Clinical trial: Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients (NCT03776669)

Eligibility criteria:
Inclusion Criteria:

          -  Patients with:

               1. Body mass index (BMI) ≧ 35, or

               2. 30 ≦ BMI < 35, with inadequately controlled type 2 diabetes mellitus (T2DM) or
                  metabolic syndrome, or

               3. T2DM with BMI ≧ 32.5, or

               4. T2DM with BMI between 27.5 and 32.5 not well controlled by medication, especially
                  for those with major cardiovascular risk.

          -  Age: 20 to 65 years old.

          -  Hiatal hernia diagnosed by either:

               1. HRIM: defined as the distance between low esophageal sphincter (LES) and crural
                  diaphragm (CD) equal to or greater than 2 cm. (LES-CD ≧ 2 cm)

               2. EGD: defined as the apparent separation between the squamocolumnar junction and
                  the diaphragmatic impression is greater than 2 cm.

        Exclusion Criteria:

          -  Prior major gastrointestinal (GI) tract surgery.

          -  Bleeding tendency.

          -  American Society of Anesthesiologists physical status (ASA) ≧ class III.

          -  Pregnancy or lactating women.

          -  Allergy to contrast medium for CT scan.

          -  Concomitantly untreated or uncontrolled endocrine disease.

          -  Alcohol or drug abuse.

          -  Mental, behavioral, and neurodevelopmental disorders.

               1. Patients who possess "National Health Insurance (NHI) Major Illness/Injury
                  Certificate" for ICD-10-CM codes F01-F99. (ICD: International Classification of
                  Diseases; CM: Clinical Modification)

               2. Patients who have been hospitalized in psychiatric ward in the recent one year.

          -  Type IV hiatal hernia.

          -  Moderate to severe reflux esophagitis (LA classification grade B/C/D) refractory to
             medical treatment.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? 0