OBJECTIVE: To re-evaluate after 5 years the results of a randomised trial of cholecystectomy and lithotripsy for the treatment of symptomatic gallstones. DESIGN: Late follow-up of a randomised controlled trial. SETTING: Teaching hospital, UK. SUBJECTS:144 of the 179 patients originally randomised. INTERVENTIONS: Either elective open cholecystectomy under general anaesthesia or a maximum of 4 sessions of lithotripsy (up to 3000 shocks/session) on consecutive days with no anaesthesia or analgesia. RESULTS: Of the original 87 patients randomised to be treated by lithotripsy, 39 (45%) subsequently underwent cholecystectomy, most of them within 32 months of treatment ("crossover" group). Patients in both main groups had a pronounced reduction in the number of episodes of pain at 5 years and significant reductions in the mean severity scores both on VAS and the McGill rating. Those in the crossover group had the worst scores. Gastrointestinal symptoms improved in the two main groups, but again the crossover group did least well. Quality of life improved significantly over baseline in the two main groups, but was much poorer in the crossover group. CONCLUSIONS:Patients who had primary cholecystectomy were more likely to be free of pain than those treated by lithotripsy. Lithotripsy gave good symptomatic results in 55% of patients, and this was not dependent on clearance of stones. Patients who had a cholecystectomy after lithotripsy had the worst symptomatic results. It is difficult to identify patients who will not benefit from lithotripsy, but the presence of many coexisting symptoms may be an important predictor.
RCT Entities:
OBJECTIVE: To re-evaluate after 5 years the results of a randomised trial of cholecystectomy and lithotripsy for the treatment of symptomatic gallstones. DESIGN: Late follow-up of a randomised controlled trial. SETTING: Teaching hospital, UK. SUBJECTS: 144 of the 179 patients originally randomised. INTERVENTIONS: Either elective open cholecystectomy under general anaesthesia or a maximum of 4 sessions of lithotripsy (up to 3000 shocks/session) on consecutive days with no anaesthesia or analgesia. RESULTS: Of the original 87 patients randomised to be treated by lithotripsy, 39 (45%) subsequently underwent cholecystectomy, most of them within 32 months of treatment ("crossover" group). Patients in both main groups had a pronounced reduction in the number of episodes of pain at 5 years and significant reductions in the mean severity scores both on VAS and the McGill rating. Those in the crossover group had the worst scores. Gastrointestinal symptoms improved in the two main groups, but again the crossover group did least well. Quality of life improved significantly over baseline in the two main groups, but was much poorer in the crossover group. CONCLUSIONS:Patients who had primary cholecystectomy were more likely to be free of pain than those treated by lithotripsy. Lithotripsy gave good symptomatic results in 55% of patients, and this was not dependent on clearance of stones. Patients who had a cholecystectomy after lithotripsy had the worst symptomatic results. It is difficult to identify patients who will not benefit from lithotripsy, but the presence of many coexisting symptoms may be an important predictor.
Authors: Mark P Lamberts; Brenda L Den Oudsten; Frederik Keus; Jolanda De Vries; Cornelis J H M van Laarhoven; Gert P Westert; Joost P H Drenth; Jan A Roukema Journal: Surg Endosc Date: 2014-06-21 Impact factor: 4.584
Authors: Mark P Lamberts; Marjolein Lugtenberg; Maroeska M Rovers; Anne J Roukema; Joost P H Drenth; Gert P Westert; Cornelis J H M van Laarhoven Journal: Surg Endosc Date: 2012-10-06 Impact factor: 4.584
Authors: Malte Schmidt; Karl Søndenaa; John A Dumot; Steven Rosenblatt; Trygve Hausken; Maria Ramnefjell; Gro Njølstad; Geir Egil Eide Journal: World J Gastroenterol Date: 2012-03-28 Impact factor: 5.742