| Source of record | UK Trials |
| ISRCTN | ISRCTN81349394 |
| Date ISRCTN assigned | 28/02/2008 |
| Local reference number(s) | N/A |
| Public title | Randomised trial of N-acetylcysteine in laparoscopic bariatric surgery |
| Scientific title | The effect of N-acetylcysteine on hepatocellular injury during laparoscopic bariatric surgery |
| Acronym | N/A |
| Disease/condition/study domain | Morbid obesity /non-alcoholic fatty liver disease |
| 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. |
| Design/methodology | Single-centre randomised controlled trial |
| Research ethics review | 1. Provisional approval granted from he King's College Hospital Research Ethics Committee as of 15/02/2008
2. Medicines and Healthcare products Regulatory Agency (MHRA) approval pending as of 15/02/2008 |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/03/2008 |
| Anticipated end date | 01/03/2010 |
| Status of trial | Ongoing |
| Target number of participants | 80 |
| Interventions | Treatment group: N-acetylcysteine 150 mg/kg lean body weight, intravenously as an infusion during surgery
Control group: No intervention |
| 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. |
| Secondary outcome measure(s) | To elucidate the mechanisms of intraoperative hepatocellular damage and the effects (if any) of N-acetylcysteine. |
| Sources of funding | King's College Hospital NHS Foundation Trust (UK) |
| Sponsor name | King's College Hospital NHS Foundation Trust (UK) |
| Sponsor details | Denmark Hill
London
United Kingdom
SE5 9RS |
| Sponsor website | http://www.kch.nhs.uk |
| Contact name | Mr A G Patel |
| Contact details | King's College Hospital
Denmark Hill
London
United Kingdom
SE59RS |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN81349394 |
| Date last extracted from ISRCTN register | 17/04/2008 |
