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
- Conditions
- on-Alcoholic Fatty Liver Disease in patients undergoing weight-loss (bariatric) surgeryMedDRA version: 9.1Level: LLTClassification code 10031743Term: Other chronic nonalcoholic liver disease
- Registration Number
- EUCTR2008-001677-15-GB
- Lead Sponsor
- King's College Hospital NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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
Patients undergoing Duodenal Switch
Patients undergoing OPEN bariatric surgery (a small minority of total patients)
Pregnancy
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method