Status:
UNKNOWN
Laparoscopic Sleeve Gastrectomy With or Without Hiatal Hernia Repair in Morbidly Obese Patients
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Morbid Obesity
Hiatal Hernia
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
Background: Obesity and hiatal hernia are both risk factors of gastroesophageal reflux disease (GERD), and the incidence of hiatal hernia is much higher in morbidly obese patients. Many believe that ...
Detailed Description
Patients and methods: A total of 70 patients will be recruited and randomized to two groups with a 1:1 allocation ratio. Patients in the control group receive LSG alone and in the experimental group ...
Eligibility Criteria
Inclusion
- Patients with:
- Body mass index (BMI) ≧ 35, or
- 30 ≦ BMI \< 35, with inadequately controlled type 2 diabetes mellitus (T2DM) or metabolic syndrome, or
- T2DM with BMI ≧ 32.5, or
- 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:
- 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)
- EGD: defined as the apparent separation between the squamocolumnar junction and the diaphragmatic impression is greater than 2 cm.
Exclusion
- 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.
- 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)
- 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.
Key Trial Info
Start Date :
January 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 17 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03776669
Start Date
January 9 2019
End Date
December 17 2024
Last Update
January 21 2022
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100