AIM: To determine the efficacy and safety benefits of performing intraoperative cholangiography (IOC) during laparoscopic cholecystectomy (LC) to treat symptomatic cholelithiasis. METHODS:Patients admitted to the Minimally Invasive Surgery Center of Tianjin Nankai Hospital between January 2012 and January 2014 for management of symptomatic cholelithiasis were recruited for this prospective randomized trial. Study enrollment was offered to patients with clinical presentation of biliary colic symptoms, radiological findings suggestive of gallstones, and normal serum biochemistry results. Study participants were randomized to receive either routine LC treatment or LC+IOC treatment. The routine LC procedure was carried out using the standard four-port technique; the LC+IOC procedure was carried out with the addition of meglumine diatrizoate (1:1 dilution with normal saline) injection via a catheter introduced through a small incision in the cystic duct made by laparoscopic scissors. Operative data and postoperative outcomes, including operative time, retained common bile duct (CBD) stones, CBD injury, other complications and length of hospital stay, were recorded for comparative analysis. Inter-group differences were statistically assessed by the χ2 test (categorical variables) and Fisher's exact test (binary variables), with the threshold for statistical significance set at P<0.05. RESULTS: A total of 371 patients were enrolled in the trial (late-adolescent to adult, age range: 16-70 years), with 185 assigned to the routine LC group and 186 to the LC+IOC group. The two treatment groups were similar in age, sex, body mass index, duration of symptomology, number and size of gallstones, and clinical symptoms. The two treatment groups also showed no significant differences in the rates of successful LC (98.38% vs 97.85%), CBD stone retainment (0.54% vs 0.00%), CBD injury (0.54% vs 0.53%) and other complications (2.16% vs 2.15%), as well as in duration of hospital stay (5.10±1.41 d vs 4.99±1.53 d). However, the LC+IOC treatment group showed significantly longer mean operative time (routine LC group: 43.00±4.15 min vs 52.86±4.47 min, P<0.01). There were no cases of fatal complications in either group. At the one-year follow-up assessment, one patient in the routine LC group reported experiencing diarrhea for three months after the LC and one patient in the LC+IOC group reported on-going intermittent epigastric discomfort, but radiological examination provided no abnormal findings. CONCLUSION: IOC addition to the routine LC treatment of symptomatic cholelithiasis does not improve rates of CBD stone retainment or bile duct injury but lengthens operative time.
RCT Entities:
AIM: To determine the efficacy and safety benefits of performing intraoperative cholangiography (IOC) during laparoscopic cholecystectomy (LC) to treat symptomatic cholelithiasis. METHODS:Patients admitted to the Minimally Invasive Surgery Center of Tianjin Nankai Hospital between January 2012 and January 2014 for management of symptomatic cholelithiasis were recruited for this prospective randomized trial. Study enrollment was offered to patients with clinical presentation of biliary colic symptoms, radiological findings suggestive of gallstones, and normal serum biochemistry results. Study participants were randomized to receive either routine LC treatment or LC+IOC treatment. The routine LC procedure was carried out using the standard four-port technique; the LC+IOC procedure was carried out with the addition of meglumine diatrizoate (1:1 dilution with normal saline) injection via a catheter introduced through a small incision in the cystic duct made by laparoscopic scissors. Operative data and postoperative outcomes, including operative time, retained common bile duct (CBD) stones, CBD injury, other complications and length of hospital stay, were recorded for comparative analysis. Inter-group differences were statistically assessed by the χ2 test (categorical variables) and Fisher's exact test (binary variables), with the threshold for statistical significance set at P<0.05. RESULTS: A total of 371 patients were enrolled in the trial (late-adolescent to adult, age range: 16-70 years), with 185 assigned to the routine LC group and 186 to the LC+IOC group. The two treatment groups were similar in age, sex, body mass index, duration of symptomology, number and size of gallstones, and clinical symptoms. The two treatment groups also showed no significant differences in the rates of successful LC (98.38% vs 97.85%), CBD stone retainment (0.54% vs 0.00%), CBD injury (0.54% vs 0.53%) and other complications (2.16% vs 2.15%), as well as in duration of hospital stay (5.10±1.41 d vs 4.99±1.53 d). However, the LC+IOC treatment group showed significantly longer mean operative time (routine LC group: 43.00±4.15 min vs 52.86±4.47 min, P<0.01). There were no cases of fatal complications in either group. At the one-year follow-up assessment, one patient in the routine LC group reported experiencing diarrhea for three months after the LC and one patient in the LC+IOC group reported on-going intermittent epigastric discomfort, but radiological examination provided no abnormal findings. CONCLUSION: IOC addition to the routine LC treatment of symptomatic cholelithiasis does not improve rates of CBD stone retainment or bile duct injury but lengthens operative time.
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