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Randomised trial of N-acetylcysteine in laparoscopic bariatric surgery

The Effect of Intraoperative N-Acetylcysteine on Hepatocellular Injury During Laparoscopic Bariatric Surgery: A Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81349394
Enrollment
80
Registered
2008-02-28
Start date
2009-04-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid obesity /non-alcoholic fatty liver disease Nutritional, Metabolic, Endocrine Morbid obesity /non-alcoholic fatty liver disease

Interventions

Treatment group: N-acetylcysteine 150 mg/kg lean body weight, intravenously as an infusion during surgery Control group: No intervention

Sponsors

King's College Hospital NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The extent of hepatocellular damage and its clinical effect, measured at post-operative days 1, 2, 3 and at 6 weeks post surgery.

Secondary

MeasureTime frame
To elucidate the mechanisms of intraoperative hepatocellular damage and the effects (if any) of N-acetylcysteine.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026