Multimedia Informed Consent & PROMs in Laparoscopic Cholecystectomy
Multimedia Informed Consent & PROMs in Laparoscopic Cholecystectomy
Collection of PROMs (Patient Reported Outcome Measures) data from patients before and after
 an operation to remove their gallbladder for the treatment of symptomatic gallstones. This
 PROMs data will provide information to clinicians and trusts about the health gain following
 this type of surgery and the impact on patient's quality of life.

 This information will be collected by the implementation of the patient Website
 aboutmyop.org. This will not only allow patients to complete quality of life (PROMs)
 questionnaires online, but will also allow them to access information on their condition and
 necessary surgery, in addition to post-operative follow-up.
Patients referred with gallstone disease necessitating surgery (laparoscopic cholecystectomy)
 will be invited to engage with our on-line interactive website. This will allow a two-way
 exchange of information in a secure environment (N3 compliant) to inform the patient about
 the risks, benefits, alternatives to surgery (cholecystectomy), and post- operative
 expectations. Furthermore, it will inform clinicians about the patient's symptoms and
 history, and record a pre-operative Patient Reported Outcome Measure (PROM). The patient's
 understanding of the facts required for informed consent will be measured and a "Patient
 Health & Understanding Report" generated for hospital clinicians. This will form part of the
 electronic patient record, and will be a medico-legal document.

 As with current practice patients will still attend their initial outpatient clinic
 appointment where they will meet a surgeon who will determine the appropriateness of surgery.
 Informed consent for surgery (cholecystectomy) will be obtained at this initial consultation
 facilitated by the information obtained from the "Patient Health & Understanding Report". The
 patient will then continue to interact with the on-line platform before and after their
 operation to ensure they are well informed and to monitor their post-operative progress.

 7 days after surgery the patient will be prompted to interact with the website to answer
 questions about their progress and recovery. This will replace the existing telephone
 follow-up interaction. Any problems identified will trigger a protocol driven interaction
 between the hospital and the patient.

 At 1, 3 and 6 months after surgery a post-operative PROMs questionnaire will be answered by
 the patient allowing comparison of pre- and post-operative PROMs. This study will lead to the
 largest PROMs assessment of the effectiveness of laparoscopic cholecystectomy, will study the
 feasibility of our Website as a multimedia application in assisting with the process of
 informed consent, and will determine whether telephone follow-up can be safely replaced by a
 protocol driven online system.
Inclusion Criteria:

 Male or female.

 -  Adults:aged 18 to 85 years.

 -  Be referred for consideration for an elective laparoscopic cholecystectomy for
 symptomatic gallstones based on their GPs diagnosis and referral to a general surgeon.

 -  Patients initially listed for laparoscopic cholecystectomy but subsequently converted
 to open cholecystectomy or subsequently have a more complex 'biliary' procedure
 (including but not exclusive to bile duct exploration, biliary drain insertion,
 biliary bypass procedure).

 Exclusion Criteria:

 -  Patients unable to, or those choosing not to engage with the multimedia process ---
 including patients lacking mental capacity, patients who do not have access to a
 multimedia device (including but not exclusive to a computer, tablet or multimedia
 phone), patients who are unable to use a multimedia device unassisted.

 -  Patients who are unable to read or communicate n English without the presence of a
 translator.

 -  Patients undergoing another major non---biliary operation during the same operation as
 their cholecystectomy.