Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-02-25 @ 4:39 PM
Study NCT ID:
NCT02810860
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2016-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimedia Informed Consent & PROMs in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017081', 'term': 'Cholecystectomy, Laparoscopic'}], 'ancestors': [{'id': 'D002763', 'term': 'Cholecystectomy'}, {'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 349}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2016-04-25', 'studyFirstSubmitQcDate': '2016-06-22', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean domain PROMs scores for each study participant', 'timeFrame': '30-Days,3 Months and 6 Months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Completion of the Multimedia Informed Consent package on aboutmyop.org', 'timeFrame': '30 days'}, {'measure': 'Completion of the 7---Day follow---up questionnaire.', 'timeFrame': '7 days'}, {'measure': 'Completion of a Patient Satisfaction Survey to receive feedback on the process.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laparoscopic cholecystectomy'], 'conditions': ['Gallstone Disease']}, 'referencesModule': {'references': [{'pmid': '35953737', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.", 'detailedDescription': '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.\n\nAs 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.\n\n7 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.\n\nAt 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nMale or female.\n\n* Adults:aged 18 to 85 years.\n* Be referred for consideration for an elective laparoscopic cholecystectomy for symptomatic gallstones based on their GPs diagnosis and referral to a general surgeon.\n* 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).\n\nExclusion Criteria:\n\n* 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.\n* Patients who are unable to read or communicate n English without the presence of a translator.\n* Patients undergoing another major non---biliary operation during the same operation as their cholecystectomy."}, 'identificationModule': {'nctId': 'NCT02810860', 'acronym': 'EPICS', 'briefTitle': 'Multimedia Informed Consent & PROMs in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Nottingham University Hospitals NHS Trust'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '15GS002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Open Label', 'description': 'Administration of a disease-specific and generic PROMs survey to patients undergoing Laparoscopic Cholecystectomy', 'interventionNames': ['Procedure: Laparoscopic cholecystectomy']}], 'interventions': [{'name': 'Laparoscopic cholecystectomy', 'type': 'PROCEDURE', 'description': 'Administration of a disease-specific and generic PROMs survey to patients undergoing Laparoscopic Cholecystectomy', 'armGroupLabels': ['Open Label']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Prita Daliya, MBChB, MRCS, PGDip(Hons)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nottingham University Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nottingham University Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'EIDO Healthcare', 'class': 'OTHER'}, {'name': 'The Royal College of Surgeons of England', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}