Randomised trial of N-acetylcysteine in laparoscopic bariatric surgery
| ISRCTN | ISRCTN81349394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81349394 |
| Secondary identifying numbers | N/A |
- 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
Scientific
King's College Hospital
Denmark Hill
London
SE59RS
United Kingdom
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2009 |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
King's College Hospital
London
SE59RS
United Kingdom
SE59RS
United Kingdom
Sponsor information
King's College Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Denmark Hill
London
SE5 9RS
England
United Kingdom
| Website | http://www.kch.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01n0k5m85 |
Funders
Funder type
Government
King's College Hospital NHS Foundation Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
14/06/2016: No publications found, verifying study status with principal investigator.
