Status:
COMPLETED
Prevalence of Steatosis and Steatohepatitis in Patients Undergoing Bariatric Surgery; a Biopsy-based Study
Lead Sponsor:
Egyptian Liver Hospital
Conditions:
Obesity
Obesity, Morbid
Eligibility:
All Genders
18+ years
Brief Summary
To study the prevalence of steatosis, steatohepatitis, and their associated risk factors in obese patients undergoing bariatric surgery.
Detailed Description
A prospective single-center biopsy-based study was conducted on 162 sleeve gastrectomy patients. Patient characteristics, including age, sex, diabetes mellitus (DM) status, body mass index (BMI), live...
Eligibility Criteria
Inclusion
- Patients undergoing laparoscopic sleeve gastrectomy ≥18 years of age.
- Able to give written informed consent.
- Scheduled, independently from this study, to have a liver biopsy (LB).
- Negative for hepatitis B surface antigen, anti-hepatitis C virus, hepatitis C virus-RNA, and hepatitis B virus DNA.
- BMI greater than or equal to 40, or BMI greater than or equal to 35 with at least one obesity-related comorbid condition (including type 2 diabetes, hypertension, hyperlipidemia, obstructive sleep apnea (OSA), GERD, asthma, venous stasis disease, severe osteoarthritis, or considerably impaired quality of life).
- Unsuccessful nonoperative weight loss attempts.
- Mental health clearance.
- Recent updates have included patients with a BMI of 30-35 with uncontrollable type 2 diabetes or metabolic syndrome as an indication for a laparoscopic sleeve gastrectomy.
Exclusion
- Patients with ascites.
- Pregnant women.
- Patients with any active implantable medical device (such as pacemaker or defibrillator).
- Patients who had undergone liver transplantation.
- Patients with cardiac failure and significant valvular disease.
- Patients with hemochromatosis.
- Patients who refused to undergo liver biopsy or blood tests.
- Patients with alcohol consumption above recommended limits (\>14 units/week for women and \>21 units/week for men; 1 unit = 8 g of ethanol).
- Patients with a confirmed diagnosis of active malignancy or another terminal disease.
- Patients participating in another clinical trial within the preceding 30 days
Key Trial Info
Start Date :
May 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT06499675
Start Date
May 1 2019
End Date
May 31 2024
Last Update
July 12 2024
Active Locations (1)
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1
Egyptian Liver Research Institute and Hospital (ELRIAH)
Sherbin, Dakahlia Governorate, Egypt, 35111