None listed
Conditions
Brief summary
Trial of a procedure specific consent form for laparoscopic cholecystectomy with a set of significant complications listed for discussion vs a standard consent form with no complications listed for discussion. To signify that a complication was discussed on the procedure specific consent form, surgeons/doctors had to tick the complication. We aimed to assess if documentation of these specific complications improved following the introduction of a procedure specific consent form. Participants were randomized to either a procedure specific or standard consent form. Outcomes measured were proportion of consent forms in each cohort with documentation of specific complications.
Interventions
Procedure specific consent form. The procedure specific form is essentially a copy of the standard consent form. However the complications section is pre-filled with a set of possible complications including: bile leak, bile duct injury, damage to other organs, conversion, bleeding and infection. These complications were the same complications listed on the Royal Australian College of Surgeons patient information brochure for laparoscopic cholecystectomy. Both procedure specific and standard consent form were randomised to envelopes, which were stored at the upper GI clinic. The surgical liaison nurse at the clinic provided an envelope to members of surgical staff consenting for laparoscopic cholecystectomy. The envelope contained either a standard or procedure specific consent form. The study assessed surgical staff behaviour. It assessed whether they document that all complications were discussed. Documenting that a complication was discussed is indicated by ticking a box next to the listed complications on the procedure specific consent form.
Sponsors
Study design
Eligibility
Inclusion criteria
Surgeon/doctor consenting participant for elective laparoscopic cholecystectomy in the upper GI outpatient clinic
Exclusion criteria
Nil