Randomized trial of laparoscopic cholecystectomy procedure-specific consent form

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.

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.

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.

Introduction of a procedure-specific consent form for laparoscopic cholecystectomy has improved the documentation of a standard set of complications.