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].
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.
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.