Randomized trial of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Early versus delayed laparoscopic cholecystectomy for acute cholecystitis: a prospective randomized trial. A comparative study of early vs. delayed laparoscopic cholecystectomy in acute cholecystitis. Laparoscopic cholecystectomy versus mini-laparotomy cholecystectomy: a prospective, randomized, single-blind study. Management of acute cholecystitis in the laparoscopic era: results of a prospective, randomized clinical trial. Prospective randomized study of early versus delayed laparoscopic cholecystectomy for acute cholecystitis. Laparoscopic versus open cholecystectomy: hospitalization, sick leave, analgesia and trauma responses. The need for antibiotic prophylaxis in elective laparoscopic cholecystectomy: a prospective randomized study. Randomized clinical trial of laparoscopic cholecystectomy performed with mini-instruments.
The aim of this prospective randomized study was to define the optimum management between early and delayed laparoscopic cholecystectomy for patients with acute cholecystitis.
                Patients were randomized to receive either early laparoscopic cholecystectomy within 24 h of randomization or initial conservative treatment followed by delayed laparoscopic cholecystectomy 6-8 weeks later.
                There were 53 patients in the early group and 51 in the delayed group. There was no significant difference in conversion rate (early 21 per cent versus delayed 24 per cent), postoperative analgesic requirement (1 versus 2 doses) and postoperative complications. However, the early group had significantly longer operating time (122.8 versus 106.6 min, P = 0.04) and shorter total hospital stay (7.6 versus 11.6 days, P < 0.001).
                Early laparoscopic cholecystectomy is safe and feasible for acute cholecystitis with the additional benefit of shorter total hospital stay. Apart from a shorter operating time, treating patients with delayed laparoscopic cholecystectomy does not offer additional benefit. The role of laparoscopic cholecystectomy for acute cholecystitis is not yet clearly established. The aim of this prospective randomized study was to evaluate the safety and feasibility of laparoscopic cholecystectomy for acute cholecystitis and to compare the results with delayed cholecystectomy.
                Between January 2001 and November 2002, 40 patients with a diagnosis of acute cholecystitis were assigned randomly to early laparoscopic cholecystectomy within 24 h of admission (early group, n = 20) or to initial conservative treatment followed by delayed laparoscopic cholecystectomy, 6 to 12 weeks later (delayed group, n = 20).
                There was no significant difference in the conversion rates (early, 25% vs delayed, 25%), operating times (early, 104 min vs delayed, 93 min), postoperative analgesia requirements (early, 5.3 days vs delayed, 4.8 days), or postoperative complications (early, 15% vs delayed, 20%). However, the early group had significantly more blood loss (228 vs 114 ml) and shorter hospital stay (4.1 vs 10.1 days).
                Early laparoscopic cholecystectomy for acute cholecystitis is safe and feasible, offering the additional benefit of a shorter hospital stay. It should be offered to patients with acute cholecystitis, provided the surgery is performed within 72 to 96 h of the onset of symptoms. To compare the outcome in early vs delayed laparoscopic cholecystectomy in terms of frequency of intra operative and postoperative complications and to determine the rate and reasons for conversion.
                A prospective randomized clinical trial was performed in the Department of Surgery at BP Koirala Institute of Health Sciences from February 2003 to June 2004 in all patients with the diagnosis of acute calculus cholecystitis.
                Out of 145 cases, 50 cases were included in our study where 12 (24%) patients were males and 38 (76%) were females (M:F=1:3.16). The mean (SD) age of patients in early and delayed groups were 42.68 yrs (14.18) and 40.26 yrs (11.62) respectively. The mean (SD) duration of symptoms in early successful and converted groups were 109.24 hrs (43.66) and 132 hrs (49.96) respectively and the mean (SD) duration of symptoms in delayed successful and converted groups were 15.36 months (13.88) and 41 months (40.73) respectively. In early group, 17 (68%) patients had total leukocyte count more than 10,000/cmm and they had ultrasound findings suggestive of acute cholecystitis. Out of 25 patients in early group, seven had jaundice and ten had deranged liver function in the preoperative period. In early group 4 (16%) patients; and in delayed group 3 (12%) had to be converted to open cholecystectomy (P=1.00). In early group 10 (40%) and in delayed 5 (20 %) cases had intraoperative complications (P=0.122). The total hospital stay was longer in the delayed group. The postoperative hospital stay in early and delayed converted groups were higher than early and delayed successful group (P=0.081, P=0.082).
                Both early and delayed laparoscopic cholecystectomy is possible and safe in the treatment of acute cholecystitis. To analyze outcomes after open small-incision surgery (minilaparotomy) and laparoscopic surgery for gallstone disease in general surgical practice.
                This study was a randomized, single-blind, multicenter trial comparing laparoscopic cholecystectomy (LC) to minilaparotomy cholecystectomy (MC). Both elective and acute patients were eligible for inclusion. All surgeons normally performing cholecystectomy, both trainees under supervision and consultants, operated on randomized patients. LC was a routine procedure at participating hospitals, whereas MC was introduced after a short training period. All nonrandomized cholecystectomies at participating units during the study period were also recorded to analyze the external validity of trial results. The randomization period was from March 1, 1997, to April 30, 1999.
                Of 1,705 cholecystectomies performed at participating units during the randomization period, 724 entered the trial and 362 patients were randomized to each of the procedures. The groups were well matched for age and sex, but there were fewer acute operations in the LC group than the MC group. In the LC group 264 and in the MC group 150 operations were performed by surgeons who had done more than 25 operations of that type. Median operating times were 100 and 85 minutes for LC and MC, respectively. Median hospital stay was 2 days in each group, but in a nonparametric test it was significantly shorter after LC. Median sick leave and time for return to normal recreational activities were shorter after LC than MC. Intraoperative complications were less frequent in the MC group, but there was no difference in the postoperative complication rate between the groups. There was one serious bile duct injury in each group, but no deaths.
                Operating time was longer and convalescence was smoother for LC compared with MC. Further analyses of LC versus MC are necessary regarding surgical training, surgical outcome, and health economy. The aim of this prospective, randomized study was to determine whether laparoscopic cholecystectomy should be performed as an early or a delayed operation in patients with acute cholecystitis. After diagnostic workup, patients were randomized to one of two groups: (1) early laparoscopic cholecystectomy (i.e., within 7 days after onset of symptoms) or (2) initial conservative treatment followed by delayed laparoscopic cholecystectomy 6 to 8 weeks later. Seventy-four patients were placed in the early-operation group, and 71 patients were assigned to the delayed-operation strategy. There was no significant difference in conversion rates (early 31% vs. delayed 29%), operating times (early 98 [range 30 to 355] minutes vs. delayed 100 [45 to 280] minutes), or complications. Failure with the conservative treatment strategy was noted in 26% of these patients. The total hospital stay was significantly shorter in the early group (5 [range 3 to 63] days) vs. the delayed group (8 [range 4 to 50] days; P<0.05). Despite a high conversion rate, early laparoscopic cholecystectomy offered significant advantages in the management of acute cholecystitis compared to a conservative strategy. The greatest advantage was a reduced total hospital stay. A prospective randomized study was undertaken to compare early with delayed laparoscopic cholecystectomy for acute cholecystitis.
                Laparoscopic cholecystectomy for acute cholecystitis is associated with high complication and conversion rates. It is not known whether there is a role for initial conservative treatment followed by interval elective operation.
                During a 26-month period, 99 patients with a clinical diagnosis of acute cholecystitis were randomly assigned to early laparoscopic cholecystectomy within 72 hours of admission (early group, n = 49) or delayed interval surgery after initial medical treatment (delayed group, n = 50). Thirteen patients (four in the early group and nine in the delayed group) were excluded because of refusal of operation (n = 6), misdiagnosis (n = 5), contraindication for surgery (n = 1), or loss to follow-up (n = 1).
                Eight of 41 patients in the delayed group underwent urgent operation at a median of 63 hours (range, 32 to 140 hours) after admission because of spreading peritonitis (n = 3) and persistent fever (n = 5). Although the delayed group required less frequent modifications in operative technique and a shorter operative time, there was a tendency toward a higher conversion rate (23% vs. 11%; p = 0.174) and complication rate (29% vs. 13%; p = 0.07). For 38 patients with symptoms exceeding 72 hours before admission, the conversion rate remained high after delayed surgery (30% vs. 17%; p = 0.454). In addition, delayed laparoscopic cholecystectomy prolonged the total hospital stay (11 days vs. 6 days; p < 0.001) and recuperation period (19 days vs. 12 days; p < 0.001).
                Initial conservative treatment followed by delayed interval surgery cannot reduce the morbidity and conversion rate of laparoscopic cholecystectomy for acute cholecystitis. Early operation within 72 hours of admission has both medical and socioeconomic benefits and is the preferred approach for patients managed by surgeons with adequate experience in laparoscopic cholecystectomy. Laparoscopic cholecystectomy has rapidly become established as the treatment of choice for cholecystolithiasis. There is very little evidence, however, to support the claimed benefit to patients. In the present study 30 consecutive patients below the age of 65 years without acute cholecystitis and with no signs of common bile duct stones were randomized to laparoscopic or conventional open cholecystectomy. Median (interquartile range) intravenous consumption of pethidine with a patient-controlled injection device between 13 and 24 h after surgery was 125 (62-175) mg in patients who underwent the laparoscopic procedure and 200 (150-250) mg in those who had open operation. Urinary adrenaline and cortisol levels as well as those of plasma glucose, C-reactive protein and interleukin 6 were increased after surgery in both groups of patients, but without any significant difference between them. The mean(s.d.) duration of postoperative hospital stay (2.8(0.8) versus 1.8(0.6) days) and sick leave (24.0(4.4) versus 11.7(4.1) days) was significantly longer with open than laparoscopic cholecystectomy. The findings demonstrate obvious advantages of laparoscopic surgery as regards postoperative pain and convalescence, although factors reflecting the magnitude of trauma did not differ. The need for antibiotic treatment when performing elective laparoscopic cholecystectomy may not be as important as it is thought. This study assesses the real efficacy of antibiotic prophylaxis in elective laparoscopic cholecystectomy with respect to the postoperative infection rate.
                A prospective randomized study on the routine use of antibiotic prophylaxis in laparoscopic cholecystectomy.
                University teaching hospital, La Sapienza, Italy.
                Eighty-four patients randomly placed into 2 groups (A [n = 44] and B [n = 40]) immediately before undergoing laparoscopic cholecystectomy.
                Before anesthesia was administered, group A received intravenously 2 g of cefotaxime sodium diluted in 100 mL of isotonic sodium chloride solution; group B, 10 mL of isotonic sodium chloride solution in 100 mL of saline. A gallbladder bile sample for culture was withdrawn intraoperatively from all patients. In both groups, age, sex, weight, duration of surgery, presence of diabetes, American Society of Anesthesiologists patient classification score, preoperative autologous blood donation, antibiotic administration, intraoperative gallbladder rupture, findings from bile culture positive for bacteria, episodes of colic within 30 days before surgery, length of postoperative hospital stay, and number of septic complications were recorded. All data were correlated by univariate and multivariate analyses with the onset of septic phenomena.
                In group A, 3 cases of wound infection, 1 case of subhepatic abscess from bile leakage, and 1 case of urinary tract infection were observed; group B, 4 cases of wound infection, 1 case of bronchopneumonia, and 2 cases of urinary tract infection. Comparison of data showed no statistically significant difference between the groups. Findings from bile examination in patients with sepsis complications were positive in 5 patients in group A and in 6 in group B (P = .91). Multivariate analysis showed diabetes mellitus and colic episodes within 30 days before surgery as independent factors significantly associated to the onset of infectious complications.
                In elective laparoscopic cholecystectomy, antibiotic treatment did not seem to affect the incidence and severity of infections or the degree of bile contamination. The outcomes after traditional laparoscopic cholecystectomy (LC; one 10-mm port, one 12-mm port and two 5-mm ports) and minilaparoscopic cholecystectomy (MLC; three 3-mm ports and one 12-mm port) for gallstone disease were compared.
                The study was a randomized, single-blind trial comparing LC with MLC. Only elective patients were eligible for inclusion. LC was a routine procedure at the institution in which the study was performed, whereas MLC was introduced after a short training period. The randomization period was from January to December 2001.
                Of 175 patients who had elective minimal access cholecystectomy during the randomization period, 135 entered the trial: 68 underwent LC and 67 underwent MLC. The groups were matched for age, sex and preoperative characteristics. Median (range) operating times for LC and MLC were similar (45 (20-120) and 50 (20-170) min respectively). Intraoperative and postoperative complication rates, the time for the patient to resume walking, eating and passing stools, and median hospital stay were the same in the two groups. The level of postoperative pain was lower in the MLC group at 1 h (P = 0.011), 3 h (P = 0.012), 6 h (P = 0.003), 12 h (P = 0.052) and 24 h (P = 0.034). Patients who had MLC received fewer injections of analgesic (P = 0.036) and more patients in this group expressed satisfaction with the cosmetic result (P = 0.001).
                MLC took a similar time to perform and caused less postoperative pain than the standard laparoscopic procedure. Reducing the port size further enhanced the advantages of laparoscopic over open cholecystectomy.
                Copyright 2003 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.
We found no significant difference between early and late laparoscopic cholecystectomy on our primary outcomes. However, trials with high risk of bias indicate that early laparoscopic cholecystectomy during acute cholecystitis seems safe and may shorten the total hospital stay. The majority of the important outcomes occurred rarely, and hence the confidence intervals are wide. It is unlikely that future randomised clinical trials will be powered to measure differences in bile duct injury and other serious complications since this might involve performing a trial of more than 50,000 people, but several smaller randomised trials may answer the questions through meta-analyses.