Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions from those outside of Australia and New Zealand. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first. International submissions should allow additional time for registration. Apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001373460
Ethics application status
Approved
Date submitted
20/09/2016
Date registered
4/10/2016
Date last updated
4/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized trial of laparoscopic cholecystectomy procedure specific consent form
Scientific title
Randomised trial assessing documentation of laparoscopic cholecystectomy complications by surgical staff on standard and procedure specific consent forms
Secondary ID [1] 290180 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Consent for laparoscopic cholecystectomy 300319 0
Condition category
Condition code
Surgery 300185 300185 0 0
Other surgery
Oral and Gastrointestinal 300203 300203 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 295937 0
Behaviour
Comparator / control treatment
Standard consent form. Standard consent form is the current standard written consent document used at Western Health. This document has an empty field where surgical staff can document possible complications discussed during an informed consent discussion. 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 staff document all possible laparoscopic cholecystectomy complications as listed on the Royal Australian College of Surgeons patient information brochure for laparoscopic cholecystectomy. These are those same complications listed on the procedure specific consent form and include bile duct injury, bile leak, bleeding, infection, damage to other organs and conversion. Documentation of the complication in the consent forms was assessed by researcher Dr Jack Crozier who reviewed consent forms on the electronic medical record system after all consent forms were uploaded onto the electronic medical record system.
Control group
Active

Outcomes
Primary outcome [1] 299671 0
Documentation of a standard set of laparoscopic cholecystectomy complications including bile duct injury, bile leak, bleeding, infection, damage to other organs and conversion. After surgical staff completed written consent forms they were processed and stored on the online medical record system following standard procedures. Identifying patient labels were affixed to study envelopes after the surgical staff completed the written consent. These envelopes were returned to study investigators by the surgical liaison nurse at the Upper GI clinic. Study investigators then used these identifying labels to review both standard and procedure specific consent forms on the medical record system. The proportion of written consent forms with documentation of individual complications including bile duct injury, bile leak, damage to other organs, infection, bleeding and conversion was assessed. We then assessed whether there was a significant difference in the proportion of consent form with documentation of these complications between the standard consent form and procedure specific consent form cohorts.
Timepoint [1] 299671 0
Documentation occurs at the time of the consent discussion
Secondary outcome [1] 327781 0
Documentation patient received information brochure. Patient information brochures have a sticker attached. When the surgical staff provide patients with a brochure, this is indicated by removing that sticker from the brochure and attaching it to the individual patient's outpatient progress note. This was reviewed by study investigators by reviewing the patient file from the outpatient clinic. This was done after the file was uploaded onto the electronic medical record system.
Timepoint [1] 327781 0
Documentation occurs at the time of consent

Eligibility
Key inclusion criteria
Surgeon/doctor consenting participant for elective laparoscopic cholecystectomy in the upper GI outpatient clinic
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Procedure specific consent form and standard consent form are randomized to numbered envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using the microsoft excel random number generator, standard or procedure specific consent forms were randomized to each envelope.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Two-sample test of differences in proportions. Assessing proportion of cases with documentation of specific complications in the procedure specific consent cohort and the standard consent cohort.

Prior to conducting the randomised trial, we performed a pilot study where we retrospectively assessed the documentation of complications including bile duct injury, bile leak, damage to other organs, bleeding, infection and conversion. This was assessed by study investigators by reviewing 39 standard consent forms for laparoscopic cholecystectomy uploaded on the electronic medical record system. This audit provided us with a baseline level of documentation in the general surgery department.

A sample size calculation was performed for the prospective randomised comparison of procedure specific and standard consent forms for laparoscopic cholecystectomy. Baseline documentation prior to study was approximately 50% for each complication. It was hypothesised that documentation of all complications using the procedure specific consent form would increase to 90% . Accepting a Type I error of 5% and a power of 80%, 25 subjects per arm were calculated for a two-sided significant difference. All analyses were conducted with Stata 12.1 (StataCorp, College Station, TX, USA).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 14340 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 294544 0
Hospital
Name [1] 294544 0
Western Health
Address [1] 294544 0
Western Health. Gordon St Footscray VIC 3011
Country [1] 294544 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
Western Health. Gordon St Footscray VIC 3011
Country
Australia
Secondary sponsor category [1] 293415 0
None
Name [1] 293415 0
None
Address [1] 293415 0
Country [1] 293415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295984 0
Western Health Low Risk Ethics Panel
Ethics committee address [1] 295984 0
Furlong Rd St Albans VIC 3021
Ethics committee country [1] 295984 0
Australia
Date submitted for ethics approval [1] 295984 0
04/12/2013
Approval date [1] 295984 0
27/12/2013
Ethics approval number [1] 295984 0
QA2013.108

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69134 0
A/Prof Graeme Thompson
Address 69134 0
Western Health Gordon St Footscray VIC 3011
Country 69134 0
Australia
Phone 69134 0
+61432535955
Fax 69134 0
Email 69134 0
gajethom@iinet.net.au
Contact person for public queries
Name 69135 0
Dr Jack Crozier
Address 69135 0
Western Health Gordon St Footscray VIC 3011
Country 69135 0
Australia
Phone 69135 0
+61432535955
Fax 69135 0
Email 69135 0
jack.crozier@wh.org.au
Contact person for scientific queries
Name 69136 0
Dr Jack Crozier
Address 69136 0
Western Health Gordon St Footscray VIC 3011
Country 69136 0
Australia
Phone 69136 0
+61432535955
Fax 69136 0
Email 69136 0
jack.crozier@wh.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary