Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT00832767
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2009-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
SILS™ Port Laparoscopic Cholecystectomy Post Market Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jessica.carlson@covidien.com', 'phone': '203-821-4734', 'title': 'Jessica Carlson', 'organization': 'Covidien'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'AEs collected from enrollment through end of study which was a period of 1 year.', 'eventGroups': [{'id': 'EG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.', 'otherNumAtRisk': 119, 'otherNumAffected': 44, 'seriousNumAtRisk': 119, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.', 'otherNumAtRisk': 81, 'otherNumAffected': 27, 'seriousNumAtRisk': 81, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Bile Duct Stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Investigation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary Retention Postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary Tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 119, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'OG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}], 'classes': [{'title': 'At least one AE', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'At least one SAE', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'At least one Device-Related AE or SAE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'At least one procedure-related AE or SAE', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One year', 'description': 'Feasibility and safety as determined by intraoperative and postoperative adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'OG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.8', 'spread': '23.2', 'groupId': 'OG000'}, {'value': '45.3', 'spread': '17.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Duration of surgical procedure in minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One site did not collect the operative time for a patient in the SILS group'}, {'type': 'PRIMARY', 'title': 'Estimated Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'OG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'spread': '35.5', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '35.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Blood loss from surgical procedure in cc.', 'unitOfMeasure': 'cc', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Average Pain Experienced in the Last 24 Hours at Various Time Frames', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'OG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}], 'classes': [{'title': 'Pre-operative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 0 (Post-operative)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': '1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': '2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Various (Pre-operative, Day 0, 1,3, 5, 1 Week, 2 Week and 1 Month)', 'description': 'Pain evaluation as determined by a 10-point pain intensity numerical rating scale (PI-NRS) ranging from 0 (no pain) to 10 (worst possible pain).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number includes patients who completed pain evaluation questionnaire.'}, {'type': 'SECONDARY', 'title': 'Body Image Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'OG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}], 'classes': [{'title': '1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': '2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)', 'description': 'The Body Image Scale consists of Questions 1-5 on the Body Image Questionnaire. Here, subjects were asked to answer each question on a scale from 1 to 4 with 1 being the best. Therefore, a total score of 5-20 was calculated for each patient with 5 being the best.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number includes participants who completed the Body Image Questionnaire.'}, {'type': 'SECONDARY', 'title': 'Cosmetic Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'OG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}], 'classes': [{'title': '1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.5', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '18.6', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': '2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.5', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '3.9', 'groupId': 'OG001'}]}]}, {'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.1', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '19.2', 'spread': '3.8', 'groupId': 'OG001'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.5', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '20.0', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.6', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '3.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)', 'description': 'The Cosmetic Scale consists of Questions 6-8 on the Body Image Questionnaire. Here, patients were asked to answer questions regarding the cosmesis of their own scar (SILS™) or scars (4PLC). The first 2 questions were answered on a scale from 1 to 7 and Question 8 from 1 to 10, both with 1 being the worst. Therefore, a total score of 3-24 was calculated for each patient with 3 being the worst.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number includes participants who completed the Cosmetic Scale'}, {'type': 'SECONDARY', 'title': 'Confidence Scale Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'OG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}], 'classes': [{'title': '1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': '2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline (Pre-Op) at 1 Week, 2 Week, 1 Month, 3 Month and 1 Year', 'description': 'The Confidence Scale consists of Questions 9 and 10 on the Body Image Questionnaire. One question is before procedure and another is after procedure. The Patients were asked to rate their overall confidence before (baseline) and after the procedure. The scores for before/after procedure range from 1 to 10 with 1 being "not very confident" and 10 being "very confident". The score difference from the before/after treatment is compared between the two procedures (4PLC and SILS™)\n\nHere, a positive score indicates that patient confidence has increased.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed includes participants who completed questions 9 \\& 10 on the Body Image Questionnaire. Mean Change from Baseline (Pre-Op).'}, {'type': 'SECONDARY', 'title': 'Normalized Scar Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'OG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}], 'classes': [{'title': 'Week 1 Q1 - Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 1 Q4 - Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 Q1 - Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 2 Q4 - Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 Q1 - Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 1 Q4 - Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 Q1 - Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 3 Q4 - Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Year 1 Q1 - Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-0.0', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Year 1 Q4 - Q2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)', 'description': "Photo Series Questionnaire (PSQ). All subjects were asked to score their own scar (Question 1), then rate 2 standardized photos (one of 4PLC scars and one of a SILS™ scar) (Questions 2 and 3, respectively) and finally rate their own scar again after viewing the photos (Question 4). All scars were rated on a scale from 1 to 10 with 10 being the best.\n\nNormalized scores were analyzed for the photo questionnaire. In order to calculate the normalized score, each patient's score of the 4PLC photo was subtracted from their score of their own scar before viewing the photos. the median values were then used to calculate statistical significance.\n\nNormalized Scores of Own Scar are reported below:\n\nQuestion 1 - Question 2 (Q1 - Q2) Question 4 - Question 2 (Q4 - Q2)\n\nIn order to calculate the normalized score for the subject's own scar, Q2 was used as baseline score since Q2 was the score for the conventional procedure 4PLC.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number includes all participants who completed the Photo Series Questionnaire.'}, {'type': 'SECONDARY', 'title': 'Modified Hollander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'OG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}], 'classes': [{'title': '1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.67', 'groupId': 'OG001'}]}]}, {'title': '2 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.29', 'groupId': 'OG001'}]}]}, {'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.51', 'groupId': 'OG001'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': '1 Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)', 'description': "Surgeons were asked to answer 6 questions regarding the appearance of their subjects' scars. Each patient's score was summed for a total score 0 to 6 with 0 being the best.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number includes all participants where Modified Hollander Score was completed.'}, {'type': 'SECONDARY', 'title': 'Physical Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'OG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}], 'classes': [{'title': 'Baseline (Pre-Op)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.1', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '50.1', 'spread': '9.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.0', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '31.8', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.8', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '40.1', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.0', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '44.1', 'spread': '10.6', 'groupId': 'OG001'}]}]}, {'title': '1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.4', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '47.5', 'spread': '6.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)', 'description': 'SF8 questionnaire was used. This scale measures health and well-being and asks patients to rank their quality of life on a scale of 1 to 5 or a scale of 1 to 6 with 1 being the best and 5 or 6 being the worst. The quality of life questionnaire contains both physical and mental components.\n\nThe raw scores are translated into one from 0 to 100, with 0 representing a very low level of QoL and 100 representing a higher QoL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number includes all participants who completed SF8 Quality of Life Questionnaire.'}, {'type': 'SECONDARY', 'title': 'Mental Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'OG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}], 'classes': [{'title': 'Baseline (Pre-Op)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.2', 'spread': '10.9', 'groupId': 'OG000'}, {'value': '49.1', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.0', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.4', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '51.3', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.4', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '53.3', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': '1 Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.0', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '53.4', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)', 'description': 'SF8 scale was used. This scale measures health and well-being and asks patients to rank their quality of life on a scale of 1 to 5 or a scale of 1 to 6 with 1 being the best and 5 or 6 being the worst. The quality of life questionnaire contains both physical and mental components.\n\nThe raw scores are translated into one from 0 to 100, with 0 representing a very low level of QoL and 100 representing a higher QoL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number includes participants who completed the SF8 questionnaire.'}, {'type': 'SECONDARY', 'title': 'Time to Cannulization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy: This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'OG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy: This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0', 'description': 'Time required to insert SILS port system or 4 individual ports was captured for each procedure in minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'FG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy\n\nSILS™ port laparoscopic cholecystectomy : This interventional arm will have a single incision laparoscopic cholecystectomy procedure.'}, {'id': 'BG001', 'title': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy\n\nFour Port Laparoscopic Cholecystectomy : This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'groupId': 'BG000', 'lowerLimit': '18.0', 'upperLimit': '77.0'}, {'value': '44.0', 'groupId': 'BG001', 'lowerLimit': '19.0', 'upperLimit': '68.0'}, {'value': '44.9', 'groupId': 'BG002', 'lowerLimit': '18.0', 'upperLimit': '77.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '148', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '202 subjects were enrolled and randomized, however 2 subjects opted not to have surgery and were removed from the study prior to the baseline visit. Therefore data is only available on 200 subjects.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 202}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-22', 'studyFirstSubmitDate': '2009-01-29', 'resultsFirstSubmitDate': '2014-11-11', 'studyFirstSubmitQcDate': '2009-01-29', 'lastUpdatePostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-22', 'studyFirstPostDateStruct': {'date': '2009-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC', 'timeFrame': 'One year', 'description': 'Feasibility and safety as determined by intraoperative and postoperative adverse events.'}, {'measure': 'Operative Time', 'timeFrame': 'Day 0', 'description': 'Duration of surgical procedure in minutes.'}, {'measure': 'Estimated Blood Loss', 'timeFrame': 'Day 0', 'description': 'Blood loss from surgical procedure in cc.'}], 'secondaryOutcomes': [{'measure': 'Average Pain Experienced in the Last 24 Hours at Various Time Frames', 'timeFrame': 'Various (Pre-operative, Day 0, 1,3, 5, 1 Week, 2 Week and 1 Month)', 'description': 'Pain evaluation as determined by a 10-point pain intensity numerical rating scale (PI-NRS) ranging from 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'Body Image Scale', 'timeFrame': 'Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)', 'description': 'The Body Image Scale consists of Questions 1-5 on the Body Image Questionnaire. Here, subjects were asked to answer each question on a scale from 1 to 4 with 1 being the best. Therefore, a total score of 5-20 was calculated for each patient with 5 being the best.'}, {'measure': 'Cosmetic Scale', 'timeFrame': 'Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)', 'description': 'The Cosmetic Scale consists of Questions 6-8 on the Body Image Questionnaire. Here, patients were asked to answer questions regarding the cosmesis of their own scar (SILS™) or scars (4PLC). The first 2 questions were answered on a scale from 1 to 7 and Question 8 from 1 to 10, both with 1 being the worst. Therefore, a total score of 3-24 was calculated for each patient with 3 being the worst.'}, {'measure': 'Confidence Scale Change From Baseline', 'timeFrame': 'Change from Baseline (Pre-Op) at 1 Week, 2 Week, 1 Month, 3 Month and 1 Year', 'description': 'The Confidence Scale consists of Questions 9 and 10 on the Body Image Questionnaire. One question is before procedure and another is after procedure. The Patients were asked to rate their overall confidence before (baseline) and after the procedure. The scores for before/after procedure range from 1 to 10 with 1 being "not very confident" and 10 being "very confident". The score difference from the before/after treatment is compared between the two procedures (4PLC and SILS™)\n\nHere, a positive score indicates that patient confidence has increased.'}, {'measure': 'Normalized Scar Scores', 'timeFrame': 'Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)', 'description': "Photo Series Questionnaire (PSQ). All subjects were asked to score their own scar (Question 1), then rate 2 standardized photos (one of 4PLC scars and one of a SILS™ scar) (Questions 2 and 3, respectively) and finally rate their own scar again after viewing the photos (Question 4). All scars were rated on a scale from 1 to 10 with 10 being the best.\n\nNormalized scores were analyzed for the photo questionnaire. In order to calculate the normalized score, each patient's score of the 4PLC photo was subtracted from their score of their own scar before viewing the photos. the median values were then used to calculate statistical significance.\n\nNormalized Scores of Own Scar are reported below:\n\nQuestion 1 - Question 2 (Q1 - Q2) Question 4 - Question 2 (Q4 - Q2)\n\nIn order to calculate the normalized score for the subject's own scar, Q2 was used as baseline score since Q2 was the score for the conventional procedure 4PLC."}, {'measure': 'Modified Hollander', 'timeFrame': 'Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year)', 'description': "Surgeons were asked to answer 6 questions regarding the appearance of their subjects' scars. Each patient's score was summed for a total score 0 to 6 with 0 being the best."}, {'measure': 'Physical Quality of Life', 'timeFrame': 'Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)', 'description': 'SF8 questionnaire was used. This scale measures health and well-being and asks patients to rank their quality of life on a scale of 1 to 5 or a scale of 1 to 6 with 1 being the best and 5 or 6 being the worst. The quality of life questionnaire contains both physical and mental components.\n\nThe raw scores are translated into one from 0 to 100, with 0 representing a very low level of QoL and 100 representing a higher QoL.'}, {'measure': 'Mental Quality of Life', 'timeFrame': 'Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week)', 'description': 'SF8 scale was used. This scale measures health and well-being and asks patients to rank their quality of life on a scale of 1 to 5 or a scale of 1 to 6 with 1 being the best and 5 or 6 being the worst. The quality of life questionnaire contains both physical and mental components.\n\nThe raw scores are translated into one from 0 to 100, with 0 representing a very low level of QoL and 100 representing a higher QoL.'}, {'measure': 'Time to Cannulization', 'timeFrame': 'Day 0', 'description': 'Time required to insert SILS port system or 4 individual ports was captured for each procedure in minutes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Laparoscopic Cholecystectomy', 'Single Incision Laparoscopic Surgery', 'Surgical Procedures, Minimally Invasive'], 'conditions': ['Gallbladder Disease']}, 'referencesModule': {'references': [{'pmid': '22549370', 'type': 'DERIVED', 'citation': 'Solomon D, Shariff AH, Silasi DA, Duffy AJ, Bell RL, Roberts KE. Transvaginal cholecystectomy versus single-incision laparoscopic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective cohort study. Surg Endosc. 2012 Oct;26(10):2823-7. doi: 10.1007/s00464-012-2253-0. Epub 2012 May 2.'}]}, 'descriptionModule': {'briefSummary': 'The objectives of this trial are:\n\n1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy\n2. monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC to objectively document the scientific merit and the perceived advantages of SILS™ Port Laparoscopic Cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18 and 85 years old.\n* Patient has a diagnosis of biliary colic with documented gallstones or polyps by imaging or Biliary dyskinesia with documented EF \\< 30%.\n* Body Mass Index (BMI) \\< 45 kg/m2.\n\nExclusion Criteria:\n\n* Any female patient, who is pregnant, suspected pregnant, or nursing.\n* Any patient with acute calculus or acalculous cholecystitis.\n* Any patient who has had an upper midline or right sub costal incision.\n* Any patient with pre-operative indication for a cholangiogram.\n* Any patient with ASA \\> 3 with normal liver function.\n* Any patient who is undergoing Peritoneal Dialysis (PD).\n* Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair.'}, 'identificationModule': {'nctId': 'NCT00832767', 'briefTitle': 'SILS™ Port Laparoscopic Cholecystectomy Post Market Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': 'AS08012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SILS Port', 'description': 'SILS™ Port Laparoscopic Cholecystectomy', 'interventionNames': ['Procedure: SILS™ port laparoscopic cholecystectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Four Port', 'description': 'Four Port Laparoscopic Cholecystectomy', 'interventionNames': ['Procedure: Four Port Laparoscopic Cholecystectomy']}], 'interventions': [{'name': 'SILS™ port laparoscopic cholecystectomy', 'type': 'PROCEDURE', 'description': 'This interventional arm will have a single incision laparoscopic cholecystectomy procedure.', 'armGroupLabels': ['SILS Port']}, {'name': 'Four Port Laparoscopic Cholecystectomy', 'type': 'PROCEDURE', 'description': 'This interventional arm will have a traditional four port laparoscopic cholecystectomy procedure.', 'armGroupLabels': ['Four Port']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Medical Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33601', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore - Long Island Jewish Health System', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '11576', 'city': 'Roslyn', 'state': 'New York', 'country': 'United States', 'facility': 'St. Francis Hospital', 'geoPoint': {'lat': 40.79982, 'lon': -73.65096}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '75390-8819', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Rome', 'country': 'Italy', 'facility': 'Catholic University of Sacred Heart', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Imperial College, England, St. Mary's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Jeffrey Marks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Medical Center University Hospitals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}