Randomised trial of N-acetylcysteine in laparoscopic bariatric surgery

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Recruitment status:
Not Recruiting
Primary Sponsor:
King's College Hospital NHS Foundation Trust (UK)
Recruitment countries:
United Kingdom
Health condition studied:
Morbid obesity /non-alcoholic fatty liver disease
Nutritional, Metabolic, Endocrine
Morbid obesity /non-alcoholic fatty liver disease
URL:
Link to the clinical trial website

About the trial

Interventions:
Treatment group: N-acetylcysteine 150 mg/kg lean body weight, intravenously as an infusion during surgery
Control group: No intervention
Key inclusion and exclusion criteria:
  • Inclusion criteria: 1. Male or Female
    2. Aged 18 to 65
    3. National Institute of Clinical Excellence criteria for morbid obesity surgery: BMI >40 or BMI >35 with obesity related complications
  • Exclusion criteria: 1. Pregnancy
    2. History of chronic liver disease, including viral hepatitis, haemachromatosis, alcoholic liver disease or known alcohol intake >20g/day
    3. Previous liver surgery, e.g., resection, orthotopic transplantation
    4. Psychiatric illness, including anxiety, mood and eating disorders
    5. Bleeding tendency or anticoagulant medications
    6. Known allergies to N-acetylcysteine or related compounds
  • Age minimum: 
  • Age maximum: 
  • Gender:  Both
Primary outcomes:
The extent of hepatocellular damage and its clinical effect, measured at post-operative days 1, 2, 3 and at 6 weeks post surgery.
Secondary outcomes:
To elucidate the mechanisms of intraoperative hepatocellular damage and the effects (if any) of N-acetylcysteine.
Target sample size:
80
Study type:
Interventional
Study design:
Single-centre randomised controlled trial (Treatment)
Contacts:
  • Name:  
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation: 
  • Name: A G Patel
  • Address:  King's College Hospital Denmark Hill
  • Phone: 
  • Email: 
  • Affiliation: 

Technical details

Scientific title:
The Effect of Intraoperative N-Acetylcysteine on Hepatocellular Injury During Laparoscopic Bariatric Surgery: A Randomised Controlled Trial
Sources of monetary support:
King's College Hospital NHS Foundation Trust (UK)
Secondary sponsors:
Main ID:
ISRCTN81349394
Secondary ID:
N/A
Register:
ISRCTN
Date of registration:
28/02/2008
Date of first enrollment:
01/04/2009
Last refreshed:
17 October 2016

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