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ISRCTN
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ISRCTN81349394
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ClinicalTrials.gov identifier
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Public title
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Randomised trial of N-acetylcysteine in laparoscopic bariatric surgery
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Scientific title
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The effect of N-acetylcysteine on hepatocellular injury during laparoscopic bariatric surgery
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Administration of N-acetylcysteine before and during the period of liver retraction will prevent or decrease the degree of liver damage due to ischaemia-reperfusion injury during laparoscopic bariatric surgery.
As of 25/03/2009 this record was updated to include new trial dates; the initial trial dates were as follows:
Initial anticipated start date: 01/03/2008
Initial anticipated end date: 01/03/2010
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Ethics approval
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1. Approval granted from the King's College Hospital Research Ethics Committee on the 21st July 2008 (ref: 08/H0808/2)
2. Medicines and Healthcare products Regulatory Agency (MHRA) approval
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Study design
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Single-centre randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Morbid obesity /non-alcoholic fatty liver disease
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2009
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Anticipated end date
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31/03/2011
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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80
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Interventions
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Treatment group: N-acetylcysteine 150 mg/kg lean body weight, intravenously as an infusion during surgery
Control group: No intervention
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Primary outcome measure(s)
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The extent of hepatocellular damage and its clinical effect, measured at post-operative days 1, 2, 3 and at 6 weeks post surgery.
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Secondary outcome measure(s)
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To elucidate the mechanisms of intraoperative hepatocellular damage and the effects (if any) of N-acetylcysteine.
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Sources of funding
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King's College Hospital NHS Foundation Trust (UK)
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Trial website
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Publications
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Contact name
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Mr
A G
Patel
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Address
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King's College Hospital
Denmark Hill
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City/town
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London
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Zip/Postcode
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SE59RS
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Country
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United Kingdom
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Sponsor
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King's College Hospital NHS Foundation Trust (UK)
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Address
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Denmark Hill
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City/town
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London
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Zip/Postcode
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SE5 9RS
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Country
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United Kingdom
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Sponsor website:
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http://www.kch.nhs.uk
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Date applied
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20/12/2007
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Last edited
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25/03/2009
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Date ISRCTN assigned
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28/02/2008
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