A retrospective comparison of older and younger adults undergoing early laparoscopic cholecystectomy for mild to moderate calculous cholecystitis.

OBJECTIVES: To compare the demographic characteristics and intra- and postoperative outcomes in elderly adults (≥75) with those of younger adults undergoing early (<5 days after onset of complaints) cholecystectomy. DESIGN: Retrospective analysis from May 2010 to August 2012. SETTING: Randomized, multicenter, clinical trial (ABCAL Study, NCT01015417). PARTICIPANTS: Individuals with mild or moderate acute calculous cholecystitis (ACC) according to the Tokyo Guidelines (N=414; n=78 aged 75-94, median 82; n=336 aged 18-74, median 49). MEASUREMENTS: Demographic characteristics and pre-, intra-, and postoperative data. RESULTS: The elderly group was more likely to have an American Society of Anesthesiologists score of 3 or greater (62% vs 23%, P<.001), higher serum creatinine (103 vs 74 µmol/L, P<.001), and more-severe ACC (moderate ACC (62% vs 50%, P=.05), gangrenous cholecystitis (38% vs 15%, P=.001)) on preoperative imaging and confirmed intraoperatively. Ulcerated mucosa (76% vs 61%, P=.001) was significantly more frequent in the elderly group. Operative time, postoperative mortality, and postoperative infectious (18% vs 14%, P=.35) and noninfectious (9% vs 3%, P=.80) complications were similar between the two groups. Median length of stay (7.0 vs 5.0 days, P=.54) and readmission rate (15% vs 4%, P=.07) were not significantly higher in the elderly group. No significant difference was observed for the subgroup of participants aged 80 and older. CONCLUSION: In this randomized trial that included a selected sample of older adults, there was no difference in major outcomes between elderly adults and their younger counterparts after early cholecystectomy. The findings are limited because important geriatric outcomes such as delirium and functional decline were not examined.

Effect of postoperative antibiotic administration on postoperative infection following cholecystectomy for acute calculous cholecystitis: a randomized clinical trial.

IMPORTANCE: Ninety percent of cases of acute calculous cholecystitis are of mild (grade I) or moderate (grade II) severity. Although the preoperative and intraoperative antibiotic management of acute calculous cholecystitis has been standardized, few data exist on the utility of postoperative antibiotic treatment. OBJECTIVE: To determine the effect of postoperative amoxicillin plus clavulanic acid on infection rates after cholecystectomy. DESIGN, SETTING, AND PATIENTS: A total of 414 patients treated at 17 medical centers for grade I or II acute calculous cholecystitis and who received 2 g of amoxicillin plus clavulanic acid 3 times a day while in the hospital before and once at the time of surgery were randomized after surgery to an open-label, noninferiority, randomized clinical trial between May 2010 and August 2012. INTERVENTIONS: After surgery, no antibiotics or continue with the preoperative antibiotic regimen 3 times daily for 5 days. MAIN OUTCOMES AND MEASURES: The proportion of postoperative surgical site or distant infections recorded before or at the 4-week follow-up visit. RESULTS: An imputed intention-to-treat analysis of 414 patients showed that the postoperative infection rates were 17% (35 of 207) in the nontreatment group and 15% (31 of 207) in the antibiotic group (absolute difference, 1.93%; 95% CI, -8.98% to 5.12%). In the per-protocol analysis, which involved 338 patients, the corresponding rates were both 13% (absolute difference, 0.3%; 95% CI, -5.0% to 6.3%). Based on a noninferiority margin of 11%, the lack of postoperative antibiotic treatment was not associated with worse outcomes than antibiotic treatment. Bile cultures showed that 60.9% were pathogen free. Both groups had similar Clavien complication severity outcomes: 195 patients (94.2%) in the nontreatment group had a score of 0 to I and 2 patients (0.97%) had a score of III to V, and 182 patients (87.8%) in the antibiotic group had a score of 0 to I and 4 patients (1.93%) had a score of III to V. CONCLUSIONS AND RELEVANCE: Among patients with mild or moderate calculous cholecystitis who received preoperative and intraoperative antibiotics, lack of postoperative treatment with amoxicillin plus clavulanic acid did not result in a greater incidence of postoperative infections. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01015417.