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Randomized trial of laparoscopic cholecystectomy procedure specific consent form

Randomised trial assessing documentation of laparoscopic cholecystectomy complications by surgical staff on standard and procedure specific consent forms

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001373460
Enrollment
64
Registered
2016-10-04
Start date
2014-09-17
Completion date
2016-08-25
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 c

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

Western Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Surgeon/doctor consenting participant for elective laparoscopic cholecystectomy in the upper GI outpatient clinic

Exclusion criteria

Nil

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026