EUCTR2008-001677-15-GB
Active, not recruiting
Not Applicable
The effect of intraoperative N-acetylcysteine on hepatocellular injury during laparoscopic bariatric surgery. A randomised controlled trial. - Randomised trial of N-acetylcysteine in laparoscopic bariatric surgery
Conditionson-Alcoholic Fatty Liver Disease in patients undergoing weight-loss (bariatric) surgeryMedDRA version: 9.1Level: LLTClassification code 10031743Term: Other chronic nonalcoholic liver disease
DrugsAcetylcysteine
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- on-Alcoholic Fatty Liver Disease in patients undergoing weight-loss (bariatric) surgery
- Sponsor
- King's College Hospital NHS Foundation Trust
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or Female
- •Age range 18 to 75 years inclusive
- •Patients must meet the criteria set out by NICE for morbid obesity surgery, that is they must have BMI \>40kg/m2 or \>35kg/m2 with obesity\-related complications, and are undergoing either Laparoscopic Adjustable Gastric Banding or Roux\-en\-Y Gastric Bypass or Laparoscopic Sleeve Gastrectomy
- •Fully informed, written consent obtained prior to enrolment into this study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Patients undergoing Duodenal Switch
- •Patients undergoing OPEN bariatric surgery (a small minority of total patients)
- •History of chronic liver disease, including viral hepatitis, haemochromatosis, alcoholic liver disease or known alcohol intake \> 28 units per week
- •Previous liver surgery, eg resection, orthotopic transplantation
- •History of active psychiatric illness, including severe depression, bipolar disorder, schizophrenia and eating disorders
- •Bleeding tendency or anticoagulant medications
- •Known allergies to N\-acetylcysteine or related compounds
Outcomes
Primary Outcomes
Not specified
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