Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The Effect of Intraoperative N-Acetylcysteine on Hepatocellular Injury During Laparoscopic Bariatric Surgery: A Randomised Controlled Trial
Acronym
Study hypothesis
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
Ethics approval
1. Approval granted from the King's College Hospital Research Ethics Committee on the 21/07/2008, ref: 08/H0808/2
2. Medicines and Healthcare products Regulatory Agency (MHRA) approval
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Morbid obesity /non-alcoholic fatty liver disease
Intervention
Treatment group: N-acetylcysteine 150 mg/kg lean body weight, intravenously as an infusion during surgery
Control group: No intervention
Intervention type
Drug
Phase
Not Specified
Drug names
N-acetylcysteine
Primary outcome measure
The extent of hepatocellular damage and its clinical effect, measured at post-operative days 1, 2, 3 and at 6 weeks post surgery.
Secondary outcome measures
To elucidate the mechanisms of intraoperative hepatocellular damage and the effects (if any) of N-acetylcysteine.
Overall trial start date
01/04/2009
Overall trial end date
31/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant 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
Recruitment start date
01/04/2009
Recruitment end date
31/03/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College Hospital
London
SE59RS
United Kingdom
Sponsor information
Organisation
King's College Hospital NHS Foundation Trust (UK)
Sponsor details
Denmark Hill
London
SE5 9RS
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
King's College Hospital NHS Foundation Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26420761