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NCT06499675Completed

Prevalence of Steatosis and Steatohepatitis in Patients Undergoing Bariatric Surgery; a Biopsy-based Study

Source: ClinicalTrials.gov · Last updated 12 Jul 2024

Brief summary (registry, in English)

To study the prevalence of steatosis, steatohepatitis, and their associated risk factors in obese patients undergoing bariatric surgery.

Status (registry)
Completed
Study type
Observational
Enrollment
272 (actual)
First submitted
7 Jul 2024
Start date
1 May 2019
Primary completion date
31 Dec 2023
Lead sponsor
Egyptian Liver Hospital
Diseases
Obesity
NCT number
NCT06499675

What you commit to

  • Study type: Observational
  • Participants enrolled: 272
  • From 1 May 2019 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who had undergone liver transplantation.

Other illness

  • Patients with cardiac failure and significant valvular disease.
  • Patients with a confirmed diagnosis of active malignancy or another terminal disease.

Other

  • Patients with ascites.
  • Pregnant women.
  • Patients with any active implantable medical device (such as pacemaker or defibrillator).
  • 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 participating in another clinical trial within the preceding 30 days

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Egyptian Liver Research Institute and Hospital (ELRIAH)
Coordinator of this site? Confirm its status
SherbinEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.