Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/12/2007
Date assigned
28/02/2008
Last edited
14/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr A G Patel

ORCID ID

Contact details

King's College Hospital
Denmark Hill
London
SE59RS
United Kingdom

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 measures

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

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

http://www.kch.nhs.uk

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

Results - basic reporting

Publication summary

2016 results in http://www.ncbi.nlm.nih.gov/pubmed/26420761

Publication citations

Additional files

Editorial Notes

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