Results
gallstones, dyspepsia, Bouveret’s syndrome, gallstone, pain, fistula
GALLSTONES, GALLSTONE, COMPLICATION, SECONDARY, EVENTS, GASTRIC OUTLET OBSTRUCTION, COMPLICATIONS
Overall, 2667 patients in 20 secondary care centres were assessed for eligibility between August 2016 and November 2019. Of these, 436 were randomised to receive either conservative management (n=218) or laparoscopic cholecystectomy (n=218; Trial profile (also see supplementary appendix 2, table S1, Reasons for preference). AUC=area under the curveBaseline characteristics. Values are number (percentage) unless stated otherwiseBMI=body mass index; CSQ=condition specific questionnaire for gallstones; MCS=mental component summary; PCS=physical component summary; SD=standard deviation.For SF-36 norm based scores, a higher score (range 0-100) indicates better quality of life. For Otago gallstones CSQ, a higher score (range 0-100) indicates higher symptom burden and therefore poorer quality of life.Confirmed by transabdominal ultrasonography or another imaging technique.Derived from two CSQ domains, pain and dyspepsia. By 18 months, 54 (25%) participants in the conservative management group and 146 (67%) in the cholecystectomy group had received surgery. The median time to surgery was 8.1 months (interquartile range 4.0-10.6; n=53) in the conservative management group and 4.5 months (2.7-6.9; n=146) in the cholecystectomy group; 46 (85%) and 142 (97%) were elective surgeries, respectively (see supplementary appendix 2, table S2). By 24 months post-randomisation, 64 (29%) participants in the conservative management group and 153 (71%) in the cholecystectomy group had received surgery. Among the 153 participants in the conservative management group who did not undergo surgery by 24 months, 15 (10%) were on a surgical waiting list, 131 (86%) were not on a surgical waiting list, and 7 (5%) withdrew from follow-up. Of the 64 participants in the cholecystectomy group, by 24 months 13 (20%) were on a surgical waiting list, 13 (20%) were not on a surgical waiting list, 5 (8%) withdrew from follow-up, and 33 (52%) declined surgery. Supplementary appendix 2, table S3 shows the baseline characteristics of those randomised to laparoscopic cholecystectomy who did and did not have surgery.
Primary outcome and quality of life secondary outcomes up to 18 monthsAUC=area under the curve; CI=confidence interval; CSQ=condition specific questionnaire; MSC=mental component summary; PCS=physical component summary; SD=standard deviation.Derived from two CSQ domains, pain and dyspepsia. For SF-36 norm-based scores, a higher score indicates better quality of life. For Otago gallstones CSQ, a higher score (range 0-100) indicates higher symptom burden and therefore poorer quality of life.The secondary outcome, area under the curve for SF-36 bodily pain up to 24 months, did not differ between the two groups (mean difference −0.1, −1.8 to 1.6; P=0.94, NHS adjusted mean costs (using the resource data combined with the national cost data for the financial year 2019/20) were higher for cholecystectomy than for conservative management (£2510 In the conservative management group, 32 (15%) participants had a complication by 18 months compared with 44 (20%) participants in the cholecystectomy group (relative risk 0.72, 95% confidence interval 0.46 to 1.14; P=0.17, Secondary outcome–complications up to 18 months. Values are number unless stated otherwiseCI=confidence interval.Relative risk of complications in the conservative management versus cholecystectomy group at 18 months was 0.72 (95% CI 0.46 to 1.14); P=0.17.One participant in each arm had their surgery converted from laparoscopic to open surgery. This was not a pre-defined complication within the C-Gall study.Bouveret’s syndrome occurs when a gallstone enters the small bowel through a bilioenteric fistula and is impacted in the duodenum or stomach, causing gastric outlet obstruction.Persistence of same symptoms reported by the patient.By 18 months, nine of 200 (5%) participants in the conservative management group and 12 of 201 (6%) in the cholecystectomy group reported further treatment (relative risk 0.75, 95% confidence interval 0.31 to 1.78; P=0.51, Secondary outcome–further treatment up to 18 months. Values are number unless stated otherwiseCI=confidence interval; ERCP=endoscopic retrograde cholangiopancreatography.Relative risk of further complications in the conservative management versus cholecystectomy group at 18 months was 0.75 (95% CI 0.31 to 1.78); P=0.51.Number followed-up.Corresponds to number of events.