title: Randomized trial of laparoscopic cholecystectomy procedure-specific consent form.
abstract: BACKGROUND
  Prior to all surgical procedures, possible risks are outlined to patients during an informed consent discussion, and they are invited to ask questions. Written consent records this discussion and signals a patient's willingness to proceed with surgery. This study aims to improve the documentation of complications discussed during laparoscopic cholecystectomy consent through the introduction of a procedure-specific consent form.
  
  
  METHODS
  Phase 1 included a retrospective analysis of possible complications documented on standard consent forms for laparoscopic cholecystectomy. Phase 2 was a prospective randomized comparison of existing standard consent forms versus procedure-specific consent forms measuring the documentation of significant complications as identified from the Royal Australasian College of Surgeons brochure for laparoscopic cholecystectomy. These include bile duct injury, bile leak, bleeding, infection, conversion and damage to other organs. The proportion of participants in each cohort with the documentation of specific complications was assessed using the two-sample test of differences in proportions.
  
  
  RESULTS
  Phase 1 of the study found that the possible risk of bleeding was documented in 82.1% of cases, while damage to other organs was only documented in 7.7%. Phase 2 of the study showed significant improvements in the documentation of specific complications for both standard and procedure-specific consent cohorts; 76.5% of participants in the procedure-specific consent cohort had all complications documented, while no participants in the phase 1 cohort had all complications documented.
  
  
  CONCLUSIONS
  Introduction of a procedure-specific consent form for laparoscopic cholecystectomy has improved the documentation of a standard set of complications.
authors.affiliation: Department of Surgery, Western Health, Footscray, Victoria, Australia.|Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Jack
authors.initials: J
authors.lastname: Crozier
authors.affiliation: Department of Surgery, Western Health, Footscray, Victoria, Australia.
authors.forename: Ann
authors.initials: A
authors.lastname: Williams
authors.affiliation: Department of Surgery, Western Health, Footscray, Victoria, Australia.|Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Steven T F
authors.initials: STF
authors.lastname: Chan
authors.affiliation: Department of Surgery, Western Health, Footscray, Victoria, Australia.|Department of Surgery, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Graeme
authors.initials: G
authors.lastname: Thompson
mesh_terms: D001315:Australia; D017081:Cholecystectomy, Laparoscopic / Q000009:adverse effects*; D015331:Cohort Studies; D032962:Consent Forms; D004282:Documentation; D006801:Humans; D011183:Postoperative Complications / Q000175:diagnosis / Q000209:etiology* / Q000628:therapy
keywords: cholecystectomy; consent forms; documentation; intraoperative complications; laparoscopic