OBJECTIVE: To compare outcome parameters for good-risk patients with classic signs, symptoms, and laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to eitherlaparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE) or endoscopic retrograde cholangiopancreatography sphincterotomy plus laparoscopic cholecystectomy (ERCP/S+LC). DESIGN: Our study was a prospective trial conducted following written informed consent, with randomization by the serially numbered, opaque envelope technique. SETTING: Our institution is an academic teaching hospital and the central receiving and trauma center for the City and County of San Francisco, California. PATIENTS: We randomized 122 patients (American Society of Anesthesiologists grade 1 or 2) meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol violators having signed out of the hospital against medical advice before 1 or both procedures were completed. INTERVENTIONS: Treatment was preoperative ERCP/S followed by LC, or LC+LCBDE. MAIN OUTCOME MEASURES: The primary outcome measure was efficacy of stone clearance from the common bile duct. Secondary end points were length of hospital stay, cost of index hospitalization, professional fees, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores. RESULTS: The baseline characteristics of the 2 randomized groups were similar. Efficacy of stone clearance was likewise equivalent for both groups. The time from first procedure to discharge was significantly shorter for LC+LCBDE (mean [SD], 55 [45] hours vs 98 [83] hours; P < .001). Hospital service and total charges for index hospitalization were likewise lower for LC+LCBDE, but the differences were not statistically significant. The professional fee charges for LC+LCBDE were significantly lower than those for ERCP/S+LC (median [SD], $4820 [1637] vs $6139 [1583]; P < .001). Patient acceptance and quality of life scores were equivalent for both groups. CONCLUSIONS: Both ERCP/S+LC and LC+LCBDE were highly effective in detecting and removing common bile duct stones and were equivalent in overall cost and patient acceptance. However, the overall duration of hospitalization was shorter and physician fees lower for LC+LCBDE. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00807729.
RCT Entities:
OBJECTIVE: To compare outcome parameters for good-risk patients with classic signs, symptoms, and laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to either laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC+LCBDE) or endoscopic retrograde cholangiopancreatography sphincterotomy plus laparoscopic cholecystectomy (ERCP/S+LC). DESIGN: Our study was a prospective trial conducted following written informed consent, with randomization by the serially numbered, opaque envelope technique. SETTING: Our institution is an academic teaching hospital and the central receiving and trauma center for the City and County of San Francisco, California. PATIENTS: We randomized 122 patients (American Society of Anesthesiologists grade 1 or 2) meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol violators having signed out of the hospital against medical advice before 1 or both procedures were completed. INTERVENTIONS: Treatment was preoperative ERCP/S followed by LC, or LC+LCBDE. MAIN OUTCOME MEASURES: The primary outcome measure was efficacy of stone clearance from the common bile duct. Secondary end points were length of hospital stay, cost of index hospitalization, professional fees, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores. RESULTS: The baseline characteristics of the 2 randomized groups were similar. Efficacy of stone clearance was likewise equivalent for both groups. The time from first procedure to discharge was significantly shorter for LC+LCBDE (mean [SD], 55 [45] hours vs 98 [83] hours; P < .001). Hospital service and total charges for index hospitalization were likewise lower for LC+LCBDE, but the differences were not statistically significant. The professional fee charges for LC+LCBDE were significantly lower than those for ERCP/S+LC (median [SD], $4820 [1637] vs $6139 [1583]; P < .001). Patient acceptance and quality of life scores were equivalent for both groups. CONCLUSIONS: Both ERCP/S+LC and LC+LCBDE were highly effective in detecting and removing common bile duct stones and were equivalent in overall cost and patient acceptance. However, the overall duration of hospitalization was shorter and physician fees lower for LC+LCBDE. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00807729.