OBJECTIVE: We hypothesized that laparoscopic cholecystectomy performed within 48 hours of admission for mild gallstone pancreatitis, regardless of resolution of abdominal pain or abnormal laboratory values, would result in a shorter hospital stay. SUMMARY OF BACKGROUND DATA: Although there is consensus among surgeons that patients with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, the precise timing of laparoscopic cholecystectomy for mild disease remains controversial. METHODS:Consecutive patients with mild pancreatitis (Ranson score <or=3) were prospectively randomized to either an early laparoscopic cholecystectomy group (within 48 hours of admission) versus a control laparoscopic cholecystectomy group (performed after resolution of abdominal pain and normalizing trend of laboratory enzymes). The primary end point was hospital length of stay. Secondary end point was a composite of rates of conversion to an open procedure, perioperative complications, and need for endoscopic retrograde cholangiography. The study was designed to enroll 100 patients with an interim analysis after 50 patients. RESULTS: At interim analysis, 50 patients were enrolled at a single university-affiliated public hospital. Of them, 25 patients were randomized to the early group and 25 patients to the control group. Patient age ranged from 18 to 74 years with a median duration of symptoms of 2 days upon presentation and a median Ranson score of 1. There were no baseline differences between the groups with regards to demographics, clinical presentation, or the presence of comorbidities. The hospital length of stay was shorter for the early cholecystectomy group (mean: 3.5 [95% CI, 2.7-4.3], median: 3 [IQR, 2-4]) compared with the control group (mean: 5.8 [95% CI, 3.8-7.9], median: 4 [IQR, 4-6] [P = 0.0016]). Six patients from the early group required endoscopic retrograde cholangiography, compared with 4 in the control group (P = 0.72). There was no statistically significant difference in the need for conversion to an open procedure or in perioperative complication rates between the 2 groups. CONCLUSION: In mild gallstone pancreatitis, laparoscopic cholecystectomy performed within 48 hours of admission, regardless of the resolution of abdominal pain or laboratory abnormalities, results in a shorter hospital length of stay with no apparent impact on the technical difficulty of the procedure or perioperative complication rate.
RCT Entities:
OBJECTIVE: We hypothesized that laparoscopic cholecystectomy performed within 48 hours of admission for mild gallstone pancreatitis, regardless of resolution of abdominal pain or abnormal laboratory values, would result in a shorter hospital stay. SUMMARY OF BACKGROUND DATA: Although there is consensus among surgeons that patients with gallstone pancreatitis should undergo cholecystectomy to prevent recurrence, the precise timing of laparoscopic cholecystectomy for mild disease remains controversial. METHODS: Consecutive patients with mild pancreatitis (Ranson score <or=3) were prospectively randomized to either an early laparoscopic cholecystectomy group (within 48 hours of admission) versus a control laparoscopic cholecystectomy group (performed after resolution of abdominal pain and normalizing trend of laboratory enzymes). The primary end point was hospital length of stay. Secondary end point was a composite of rates of conversion to an open procedure, perioperative complications, and need for endoscopic retrograde cholangiography. The study was designed to enroll 100 patients with an interim analysis after 50 patients. RESULTS: At interim analysis, 50 patients were enrolled at a single university-affiliated public hospital. Of them, 25 patients were randomized to the early group and 25 patients to the control group. Patient age ranged from 18 to 74 years with a median duration of symptoms of 2 days upon presentation and a median Ranson score of 1. There were no baseline differences between the groups with regards to demographics, clinical presentation, or the presence of comorbidities. The hospital length of stay was shorter for the early cholecystectomy group (mean: 3.5 [95% CI, 2.7-4.3], median: 3 [IQR, 2-4]) compared with the control group (mean: 5.8 [95% CI, 3.8-7.9], median: 4 [IQR, 4-6] [P = 0.0016]). Six patients from the early group required endoscopic retrograde cholangiography, compared with 4 in the control group (P = 0.72). There was no statistically significant difference in the need for conversion to an open procedure or in perioperative complication rates between the 2 groups. CONCLUSION: In mild gallstone pancreatitis, laparoscopic cholecystectomy performed within 48 hours of admission, regardless of the resolution of abdominal pain or laboratory abnormalities, results in a shorter hospital length of stay with no apparent impact on the technical difficulty of the procedure or perioperative complication rate.
Authors: Pablo Giuffrida; David Biagiola; Agustín Cristiano; Victoria Ardiles; Martín de Santibañes; Rodrigo Sanchez Clariá; Juan Pekolj; Eduardo de Santibañes; Oscar Mazza Journal: Updates Surg Date: 2020-02-03