A randomised controlled trial comparing laparoscopic cholecystectomy with observation/conservative management for preventing recurrent symptoms and complications in adults with uncomplicated symptomatic gallstones
Gallstones
1. Laparoscopic cholecystectomy: the current standard surgical procedure for the management of symptomatic gallstone disease. The gall bladder is removed with the stones within it using keyhole techniques (laparoscopy). The procedure is undertaken under a general anaesthetic. It usually involves three to four small incisions in the abdomen, which allow the surgeon to dissect the gallbladder from its attachments and safely divide the key anatomical structures (the cystic duct and artery) that link it to the biliary tree. The gallbladder is then separated from the under surface of the liver. Usually the gallbladder (containing the stones) is removed within a retrieval bag via one of the small incisions. The operation takes between 45 and 120 minutes, many patients are admitted for one night, although day case laparoscopic cholecystectomy is safely undertaken in an otherwise fit patients with appropriate social support. 2. Observation/conservative management: observation/conservative management in the context of gallstone disease involves the prescription of analgesics to relieve the biliary pain. Typical therapy includes paracetamol, antispasmotics (e.g. Buscopan), nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g. ibuprofen etc), narcotic analgesics (e.g. opiates) together with generic lifestyle advice. In the longer term, conservative management also may involve these strategies for symptom management if required, as well as advice to eat a healthy diet with regular meals (http://www.nhs.uk/Conditions/Gallstones/Pages/Treatment.aspx). For the purpose of this trial a standard protocol for conservative management will be agreed with the PPI group and used in all centres. Safety advice for patients in the observation/conservative management group will be aligned with the current advice given via the NHS choice website (www.nhs.uk).
All adult patients with confirmed gallstones electively referred to a secondary care setting for consultation. Clinical diagnosis of gallstone disease will be confirmed by imaging. Transabdominal ultrasonography is the standard imaging technique for the diagnosis of gallbladder stones, but diagnosis by any imaging technique is acceptable.
1. Unable to consent 2. ASA III and above 3. Pregnancy 4. Previous open major upper abdominal surgery 5. Gallstones in common bile duct or evidence of previous choledocholithiasis 6. A history of acute pancreatitis 7. Abnormal liver function tests (with the exception of GGT <90u/L) 8. Evidence of empyema of the gallbladder 9. Perforated gallbladder 10. Haemolytic disease