Cost-effectiveness analysis of laparoscopic versus minilaparotomy cholecystectomy for gallstone disease. A randomized trial. Laparoscopic cholecystectomy: day-care versus clinical observation. Randomized clinical trial of day-care versus overnight-stay laparoscopic cholecystectomy. Laparoscopic cholecystectomy versus mini-laparotomy cholecystectomy: a prospective, randomized, single-blind study. [Laparoscopic versus mini-cholecystectomy: analysis of hospital costs and social costs in a prospective randomized study]. Wait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial. The need for antibiotic prophylaxis in elective laparoscopic cholecystectomy: a prospective randomized study. [Value of absorbable clips in laparoscopic cholecystectomy. A randomized prospective study]. [Laparoscopic versus open cholecystectomy: a prospective randomized study].
To evaluate the total cost of minilaparotomy cholecystectomy (MC) and laparoscopic cholecystectomy (LC) and perform a cost-effectiveness (CE) analysis.
                One hundred adult subjects with painful gallstone disease were randomized: 59 cases for LC and 41 cases for MC. Patients with gallstones shown on ultrasound with normal common bile duct and no history of icterus were included after an informed consent. Cases with acute cholecystitis and raised alkaline phosphatase were excluded. LC was performed using CO2 insufflation and a Storz 2D video camera. MC was done by transverse rectus cutting incision. Outcome was coded as success or failure. Success was defined as operation without injury to bile duct, viscera or vessels, minimal pain and discomfort at 4 weeks, no wound infection up to 4 weeks, and resumption of work within 2 weeks of operation. The total cost of each case included cost of investigations, cost of disposable articles for operation, cost of drugs, cost of hospital stay, and cost of operation including anesthesia. LC and MC were done with reusable instruments. A "societal viewpoint" has been taken in the cost calculations.
                There were 50/59 successful outcomes in LC and 15/40 outcomes in MC group. Total cost for LC was 386,769 rupees (Rs) and for MC was Rs 205,041. CE in LC was Rs 7,735 and in MC was Rs 13,669. Incremental CE ratio comparing LC with MC was 3,028.33.
                LC is a more cost-effective method for treatment of gallstone disease. To determine the feasibility and desirability of laparoscopic cholecystectomy (LC) in day-care versus LC with clinical observation.
                Laparoscopic cholecystectomy has been performed regularly as outpatient surgery in patients with uncomplicated gallstone disease in the United States, but this has not been generally accepted in Europe. The main objections are the risk of early severe complications (bleeding) or other reasons for readmission, and the argument that patients might feel safer when observed for one night. Quality-of-life differences hitherto have not been investigated.
                Eighty patients (American Society of Anesthesiology [ASA] I/II) with symptomatic gallstones were randomized to receive LC either in day-care or with clinical observation. Complications, (re)admissions, consultations of general practitioners or the day-care center within 4 days after surgery, use of pain medication, quality of life, convalescence period, time off from professional activities, and treatment preference were assessed. The respective costs of day-care and clinical observation were determined.
                Of the 37 patients assigned to the day-care group who underwent elective surgery, 92% were discharged successfully after an observation period of 5.7+/-0.2 hours. The remainder of the patients in this group were admitted to the hospital and clinically observed for 24 hours. For the 37 patients in the clinical observation group who underwent elective surgery, the observation time after surgery was 31+/-3 hours. Three patients in the day-care group and one patient in the clinical observation group had complications after surgery. None of the patients in either group consulted a general practitioner or the hospital during the first week after surgery. Use of pain medication was comparable in both groups over the first 48 hours after surgery. There were no differences in pain and other quality-of-life indicators between the groups during the 6 weeks of follow-up. Of the patients in the day-care group, 92% preferred day-care to clinical observation. The same percentage of patients in the clinical observation group preferred at least 24 hours of observation to day-care. Costs for the day-care patients were substantially lower (approximately $750/patient) than for the clinical observation patients.
                Effectiveness was equal in both patient groups, and both groups appeared to be satisfied with their treatment. Because no differences were found with respect to the other outcomes, day-care is the preferred treatment in most ASA I and II patients because it is less expensive. Laparoscopic cholecystectomy has been performed as a day-care procedure for many years. Few studies have been conducted with primary focus on patient acceptance and preferences in terms of quality of life for this practice compared with overnight stay.
                Data from 100 patients with symptomatic gallstones randomized to laparoscopic cholecystectomy performed either as a day-care procedure or with overnight stay were analysed. Complications, admissions and readmissions, quality of life and health economic aspects were assessed. Two instruments were used to assess quality of life, the Hospital Anxiety and Depression Scale (HADS) and the Psychological General Well-Being Index (PGWB).
                Forty-eight (92 per cent) of 52 patients in day-care group were discharged 4-8 h after the operation. Forty-two (88 per cent) of 48 in the overnight group went home on the first day after surgery. The overall conversion rate was 2 per cent. Two patients had complications after surgery, both in the day-care group. No patient in either group was readmitted. There was no significant difference in total quality of life score between the two groups. The mean direct medical cost per patient in the day-care group (3085 Euros) was lower than that in the overnight group (3394 Euros).
                Laparoscopic cholecystectomy can be performed as a day-case procedure with a low rate of complications and admissions/readmissions. Patient acceptance in terms of quality of life variables is similar to that for cholecystectomy with an overnight stay. The day-care strategy is associated with a reduction in cost.
                Copyright 2005 British Journal of Surgery Society Ltd. 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 the study was to calculate the hospital and social costs in relation to efficacy of clinical outcome, hospital stay and time off work in two groups of patients randomly treated with laparoscopic or mini-cholecystectomy. One hundred and eighty-one patients with simple, symptomatic gallstone disease were included in the study; of these, 9 cases were excluded because of conversion to conventional cholecystectomy. Eighty-six cases underwent laparoscopic cholecystectomy and 86 mini-cholecystectomy. Operative time (median time: 35 minutes) and hospital stay (median stay: 3 days) were the same for both surgical procedures. The median time off work was 10 days for laparoscopic cholecystectomy and 20 days for mini-cholecystectomy (P = 0.007). Hospital expenses showed a saving of 820.48 euros for each patient undergoing mini-cholecystectomy. Since laparoscopic cholecystectomy is associated with a shorter period off work, it seems to be cheaper with a daily saving of 164.96 and 146.51 Euros per patient, according to cost/effectiveness and cost/utility analyses, respectively. Consequently, although laparoscopic cholecystectomy shows a better outcome in terms of socioeconomic aspects and patient compliance, in an attempt to rationalize hospital expenditure, we would advocate mini-cholecystectomy for those patients who do not need to return to work early. Patients who undergo endoscopic sphincterotomy for common bile-duct stones, who have residual gallbladder stones, are referred for laparoscopic cholecystectomy. However, only 10% of patients who do not have this operation are reported to develop recurrent biliary symptoms. We aimed to assess whether a wait-and-see policy is justified.
                We did a prospective, randomised, multicentre trial in 120 patients (age 18-80 years) who underwent endoscopic sphincterotomy and stone extraction, with proven gallbladder stones. Patients were randomly allocated to wait and see (n=64) or laparoscopic cholecystectomy (56). Primary outcome was recurrence of at least one biliary event during 2-year follow-up, and secondary outcomes were complications of cholecystectomy and quality of life. Analysis was by intention to treat.
                12 patients were lost to follow-up immediately. Of 59 patients allocated to wait and see, 27 (47%) had recurrent biliary symptoms compared with one (2%) of 49 patients after laparoscopic cholecystectomy (relative risk 22.42, 95% CI 3.16-159.14, p<0.0001). 22 (81%) of 27 patients underwent cholecystectomy, mainly for biliary pain (n=13) or acute cholecystitis (7). Conversion rate to open surgery was 55% in patients allocated to wait and see who underwent cholecystectomy compared with 23% in those who were allocated laparoscopic cholecystectomy (p=0.0104). Morbidity was 32% versus 14% (p=0.1048), and median hospital stay was 9 versus 7 days. Quality of life returned to normal within 3 months after either treatment policy.
                A wait-and-see policy after endoscopic sphincterotomy in combined cholecystodocholithiasis cannot be recommended as standard treatment, since 47% of expectantly managed patients developed at least one recurrent biliary event and 37% needed cholecystectomy. No major biliary complications arose, but conversion rate was high. 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. Most surgeons use metal clips in laparoscopic cholecystectomy. The aim of this prospective randomized controlled study was to evaluate the efficacy of absorbable clips in elective laparoscopic cholecystectomy. One hundred consecutive patients with symptomatic gallstones without complications were randomized into groups; group T had two metal clips (titan clip ETHICONR), group R (laproclipR Davis and Geck) had one absorbable clip applied on the cystic duct and cystic artery. The patients were followed for one year. There was no difference between the two groups concerning operative time, hospital stay and postoperative complications. The absorbable clips seem to be as effective as metal clips in providing hemostasis in cystic artery and in cystic duct ligation. A prospective randomized study of laparoscopic versus open cholecystectomy was carried out fro December 1991 to June 1992 at the Chang Gung Memorial Hospital. Laparoscopic cholecystectomy was performed in 50 cases in group A and open cholecystectomy in 51 cases in group B. All patients had a preoperative history of biliary tract disease and most had gall stones proved by sonography. There was no operative mortality in either group and the postoperative complication rates were 4.4% and 2% in group A and B respectively (p > 0.05). Prolonged operative time in group A was 85.7 +/- 25.2 min vs group B 48.0 +/- 13.9 min (p < 0.001). Postoperative bowel function recovery with toleration of a regular diet in group A was faster than group B (45.6 +/- 19.2 hrs vs 55.2 +/- 11.0 hrs, p < 0.001). The need for postoperative narcotic drugs with demerol injection was less in group A (40%) than group B (86%) (p < 0.001). The total cost for group A was NT $42139 +/- 7135 and for group B was NT $38085 +/- 7578 (p > 0.05). The interval of return to full activity for group A was shorter than group B (12.8 +/- 8.8 days vs 35.9 +/- 20.6 days respectively p < 0.001). Recurrent symptoms within the 6 to 13 month postoperative follow up period was 8% in group A and 11.7% in group B (p > 0.05). Only one patient in group B was proved to have a recurrent common bile duct stone by endoscopic retrograde cholangiography and received choledocholithotomy again.
Day-case elective laparoscopic cholecystectomy seems to be a safe and effective intervention in selected patients (with no or minimal systemic disease and within easy reach of the hospital) with symptomatic gallstones. Because of the decreased hospital stay, it is likely to save costs.