Gallstone DiseaseEPICSNCT02810860
Multimedia Informed Consent & PROMs in Laparoscopic Cholecystectomy
A study testing Laparoscopic cholecystectomy in people with Gallstone Disease, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gallstone Disease
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 349 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Aug 2016to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham
About this study
Official title: A Study to Pilot the Use of a Multimedia Application to Collect the Largest PROMs (Patient Reported Outcome Measures) Dataset in Adult Patients Undergoing Elective Laparoscopic Cholecystectomy for Symptomatic Gallstones and to Aid the Informed Consent Process
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.
Read the detailed description
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.
- Conditions
- Gallstone Disease
- Being tested
- Laparoscopic cholecystectomy
- Keywords
- laparoscopic cholecystectomy
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Administration of a disease-specific and generic PROMs survey to patients undergoing Laparoscopic Cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Other | Administration of a disease-specific and generic PROMs survey to patients undergoing Laparoscopic Cholecystectomy Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean domain PROMs scores for each study participant
We will look at the change in score between: pre--op and 30-Days, Pre-op and 3 Months post-op and pre-op and 6 months post-op. For this analysis we hope to use the paired t---test, however depending on whether the data is normally distributed or not this may require non---parametric analyses with the Wilcoxon rank---sum test. We also aim to look at the overall trend, which will require analysis of variance.
Measured: 30-Days,3 Months and 6 Months
Secondary outcomes (3)
Completion of the Multimedia Informed Consent package on aboutmyop.org
Measured: 30 days
Completion of the 7---Day follow---up questionnaire.
Measured: 7 days
Completion of a Patient Satisfaction Survey to receive feedback on the process.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study start18 Aug 2016
- Primary completion13 Apr 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gallstone DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 349 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- EIDO Healthcare, The Royal College of Surgeons of England
- Responsible party
- Sponsor
- Investigators
- Prita Daliya, MBChB, MRCS, PGDip(Hons), Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810860
- Sponsor's protocol ID
- 15GS002
- Acronym
- EPICS
- Status last verified
- Dec 2016
- First submitted
- 25 Apr 2016
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Daliya P, Carvell J, Rozentals J, Lobo DN, Parsons SL. Digital Follow-Up After Elective Laparoscopic Cholecystectomy: A Feasibility Study. World J Surg. 2022 Nov;46(11):2648-2658. doi: 10.1007/s00268-022-06684-w. Epub 2022 Aug 11.
PubMed 35953737
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Pilot the Use of a Multimedia Application to Collect the Largest PROMs (Patient Reported Outcome Measures) Dataset in Adult Patients Undergoing Elective Laparoscopic Cholecystectomy for Symptomatic Gallstones and to Aid the Informed Consent Process
- ClinicalTrials.gov ID
- NCT02810860
- Acronym / sponsor ID
- EPICS / 15GS002
- Conditions
- Gallstone Disease
- Keywords
- laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 349 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- EIDO Healthcare, The Royal College of Surgeons of England
- Study start
- 18 Aug 2016 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Other | Procedure: Laparoscopic cholecystectomyAdministration of a disease-specific and generic PROMs survey to patients undergoing Laparoscopic Cholecystectomy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomyAdministration of a disease-specific and generic PROMs survey to patients undergoing Laparoscopic Cholecystectomy | Procedure or surgery | Open Label |
Primary outcome
Mean domain PROMs scores for each study participant
Time frame: 30-Days,3 Months and 6 Months
We will look at the change in score between: pre--op and 30-Days, Pre-op and 3 Months post-op and pre-op and 6 months post-op. For this analysis we hope to use the paired t---test, however depending on whether the data is normally distributed or not this may require non---parametric analyses with the Wilcoxon rank---sum test. We also aim to look at the overall trend, which will require analysis of variance.
3 secondary outcomes
Completion of the Multimedia Informed Consent package on aboutmyop.org
Time frame: 30 days
Completion of the 7---Day follow---up questionnaire.
Time frame: 7 days
Completion of a Patient Satisfaction Survey to receive feedback on the process.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 35953737Daliya P, Carvell J, Rozentals J, Lobo DN, Parsons SL. Digital Follow-Up After Elective Laparoscopic Cholecystectomy: A Feasibility Study. World J Surg. 2022 Nov;46(11):2648-2658. doi: 10.1007/s00268-022-06684-w. Epub 2022 Aug 11.
- Individual participant dataSharing planned: No
Related trials for Gallstone Disease
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Active, not recruiting
Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
Gallstones, Pain
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prita Daliya, MBChB, MRCS, PGDip(Hons) principal investigator
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cholecystectomy in people with Gallstone Disease, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean domain PROMs scores for each study participant (time frame: 30-Days,3 Months and 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02810860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.