O A Khan1, S Balaji, G Branagan, D H Bennett, N Davies. 1. Department of Upper Gastrointestinal Surgery, Royal Bournemouth Hospital, Castle Lane East, Bournemouth BH7 7DW, UK. omarkhan@iname.com.
Abstract
BACKGROUND: A randomized clinical trial was undertaken to assess the utility of routine on-table cholangiography (OTC) during laparoscopic cholecystectomy for gallstone disease. METHODS: Some 190 patients with a history of biliary colic or cholecystitis and a low predictive risk for choledocholithiasis were randomized to undergo elective laparoscopic cholecystectomy alone (99 patients) orelective laparoscopic cholecystectomy with OTC (91). Intraoperative findings and postoperative outcomes for the two groups were compared. The primary outcome measure was the incidence of common bile duct (CBD) stones. RESULTS: Of the patients undergoing OTC, ten had abnormal cholangiograms; three had CBD stones and seven had abnormalities without stones. OTC was associated with a significantly longer mean(s.e.m.) operating time (66(2) versus 54(3) min; P < 0·001), but there was no association between performance of OTC and postoperative morbidity. During a 1-year follow-up, no patient in the OTC group re-presented to hospital with recurrent biliary symptoms. In contrast, four of the patients allocated to surgery alone re-presented with symptoms suggestive of CBD obstruction; all settled with conservative treatment and the difference in readmission rate was not significant (P = 0·122). CONCLUSION:Routine cholangiography in patients with a low risk for CBD stones does not seem justified from the results of this trial. REGISTRATION NUMBER: NCT00806780 (http://www.clinicaltrials.gov).
RCT Entities:
BACKGROUND: A randomized clinical trial was undertaken to assess the utility of routine on-table cholangiography (OTC) during laparoscopic cholecystectomy for gallstone disease. METHODS: Some 190 patients with a history of biliary colic or cholecystitis and a low predictive risk for choledocholithiasis were randomized to undergo elective laparoscopic cholecystectomy alone (99 patients) or elective laparoscopic cholecystectomy with OTC (91). Intraoperative findings and postoperative outcomes for the two groups were compared. The primary outcome measure was the incidence of common bile duct (CBD) stones. RESULTS: Of the patients undergoing OTC, ten had abnormal cholangiograms; three had CBD stones and seven had abnormalities without stones. OTC was associated with a significantly longer mean(s.e.m.) operating time (66(2) versus 54(3) min; P < 0·001), but there was no association between performance of OTC and postoperative morbidity. During a 1-year follow-up, no patient in the OTC group re-presented to hospital with recurrent biliary symptoms. In contrast, four of the patients allocated to surgery alone re-presented with symptoms suggestive of CBD obstruction; all settled with conservative treatment and the difference in readmission rate was not significant (P = 0·122). CONCLUSION: Routine cholangiography in patients with a low risk for CBD stones does not seem justified from the results of this trial. REGISTRATION NUMBER: NCT00806780 (http://www.clinicaltrials.gov).
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