title: Expertise-based randomized clinical trial of laparoscopic versus small-incision open cholecystectomy.
abstract: BACKGROUND
  Several randomized clinical trials have compared laparoscopic cholecystectomy (LC) and small-incision open cholecystectomy (SIOC). Most have had wide exclusion criteria and none was expertise-based. The aim of this expertise-based randomized trial was to compare healthcare costs, quality of life (QoL), pain and clinical outcomes after LC and SIOC.
  
  
  METHODS
  Patients scheduled for cholecystectomy were randomized to treatment by one of two teams of surgeons with a preference for either LC or SIOC. Each team performed their specific method (SIOC or LC) as a first-choice operation, but converted to open cholecystectomy and common bile duct exploration when necessary. Intraoperative cholangiography was carried out routinely. The intention was to include all patients undergoing cholecystectomy, including emergency operations and procedures involving surgical training for residents.
  
  
  RESULTS
  Some 74·9 per cent of all patients undergoing cholecystectomy were included. Of 355 patients randomized, 333 were analysed. Self-estimated QoL scores in 258 patients, analysed by the area under the curve method, were significantly lower in the SIOC group at 1 month after surgery: median 2326 (95 per cent confidence interval 2187 to 2391) compared with 2411 (2334 to 2502) for the LC group (P = 0·030). The mean(s.d.) duration of operation was shorter for SIOC: 97(41) versus 120(48) min (P < 0·001). There were no significant differences between the groups in conversion rate, pain, complications, length of hospital stay or readmissions.
  
  
  CONCLUSIONS
  SIOC had comparable surgical results but slightly worse short-term QoL compared with LC.
  
  
  BACKGROUND
  NCT00370344 (http://www.clinicaltrials.gov).
authors: Department of Surgery and Perioperative Sciences, Umeå University, Umeå, Sweden. mats.rosenmuller@surgery.umu.se
authors: M H
authors: MH
authors: Rosenmüller
authors: M
authors: M
authors: Thorén Örnberg
authors: T
authors: T
authors: Myrnäs
authors: O
authors: O
authors: Lundberg
authors: E
authors: E
authors: Nilsson
authors: M M
authors: MM
authors: Haapamäki
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000700:Analgesics / Q000627:therapeutic use; D002763:Cholecystectomy / Q000009:adverse effects / Q000191:economics / Q000379:methods*; D017081:Cholecystectomy, Laparoscopic / Q000009:adverse effects / Q000191:economics / Q000379:methods; D002983:Clinical Competence / Q000592:standards; D005260:Female; D042882:Gallstones / Q000191:economics / Q000601:surgery*; D013502:General Surgery / Q000592:standards; D017721:Hospital Costs; D006801:Humans; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D010147:Pain Measurement; D010149:Postoperative Pain / Q000209:etiology; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000700:Analgesics