Randomised trial of N-acetylcysteine in laparoscopic bariatric surgery

ISRCTN	ISRCTN81349394
DOI	https://doi.org/10.1186/ISRCTN81349394
Protocol serial number	N/A
Sponsor	King's College Hospital NHS Foundation Trust (UK)
Funder	King's College Hospital NHS Foundation Trust (UK)

Submission date: 20/12/2007
Registration date: 28/02/2008
Last edited: 14/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr A G Patel
Scientific

King's College Hospital
Denmark Hill
London
SE59RS
United Kingdom

Study information

Primary study design	Interventional
Study design	Single-centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The Effect of Intraoperative N-Acetylcysteine on Hepatocellular Injury During Laparoscopic Bariatric Surgery: A Randomised Controlled Trial
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	N-acetylcysteine
Primary outcome measure(s)	The extent of hepatocellular damage and its clinical effect, measured at post-operative days 1, 2, 3 and at 6 weeks post surgery.
Key secondary outcome measure(s)	To elucidate the mechanisms of intraoperative hepatocellular damage and the effects (if any) of N-acetylcysteine.
Completion date	31/03/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key 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
Key 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
Date of first enrolment	01/04/2009
Date of final enrolment	31/03/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

King's College Hospital

London
SE59RS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/06/2016: No publications found, verifying study status with principal investigator.