Laparoscopic common bile duct exploration versus open surgery: comparative prospective randomized trial.

The aim of the study was to analyse safety and benefits of laparoscopic common bile duct (CBD) exploration compared to open. Prospective randomized trial included a total of 256 patients with CBD stones operated from 2005 to 2009 years in a single center. There were two groups of patients: group I-laparoscopic CBD exploration (138 patients), group II-open CBD exploration (118 patients). Patient comorbidity was assessed by means of the American Society of Anesthesiology (ASA) score; i.e. ASA II-109 patients, ASA III-59 patients. Bile duct stones were visualized preoperatively by means of US examination in 129 patients, by means of ERCP in 26 patients, by magnetic resonance cholangiopancreatography in 72 patients. Preoperative evaluation was done through medical history, biochemical tests and ultrasonography. There was no statistical significant difference between 2 groups of patients. No mortality occurred. The mean duration of laparoscopic operations was 82 min (range, 40-160 min). The mean duration of open operations were 90 min (range, 60-150 min). Mean blood loss was much less in laparoscopic group than in open group (20 ± 2 vs. 285 ± 27 ml; p < 0.01). Postoperative complications were observed is nine patients of laparoscopic group and in 15 patients in open group (p < 0.01). There were 102 attempts to perform transcystic exploration of CBD. External drainage was used in 25 (32.8%) patients with transcystic approach. Conversion to laparotomy was performed in two patients. Open operations were performed in 118 patients with choledocholithiasis. External drainage was used in 85% of patients. Morbidity in open group was higher (12.7%) than in laparoscopic group (6.5%). Laparoscopic CBD exploration can be performed with high efficiency, minimal morbidity and mortality. Laparoscopic procedures have advances over open operations in terms of postoperative morbidity and length of hospital stay.

RCT Entities:   Population Interventions Outcomes