Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-28 @ 10:46 AM
Study NCT ID:
NCT00749268
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2008-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}, {'id': 'D006555', 'term': 'Hernia, Ventral'}, {'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jessica.carlson@covidien.com', 'phone': '(203) 821-4734', 'title': 'Jessica Carlson, Clinical Project Manager', 'organization': 'Covidien'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events collected from time of randomization through 1 year.', 'description': 'Inguinal Arm - 1 patient randomized to ProTack group was treated w/AbsorbaTack and 1 patient randomized to the AbsorbaTack group was treated w/ProTack, so these 2 patients were not included in the safety analysis set.\n\nVentral Arm - 1 patient randomized to the AbsorbaTack group was treated w/ProTack so what not included in the safety analysis set', 'eventGroups': [{'id': 'EG000', 'title': 'Inguinal Arm - AbsorbaTack', 'description': 'Inguinal hernia study arm with AbsorbaTack as treatment.', 'otherNumAtRisk': 53, 'otherNumAffected': 17, 'seriousNumAtRisk': 53, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Inguinal Arm - ProTack', 'description': 'Inguinal hernia study arm with ProTack as treatment.', 'otherNumAtRisk': 51, 'otherNumAffected': 20, 'seriousNumAtRisk': 51, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Ventral Arm - Absorbatack', 'description': 'Ventral hernia study arm with AbsorbaTack as treatment.', 'otherNumAtRisk': 55, 'otherNumAffected': 24, 'seriousNumAtRisk': 55, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Ventral Arm - ProTack', 'description': 'Ventral hernia study arm with ProTack as treatment.', 'otherNumAtRisk': 54, 'otherNumAffected': 33, 'seriousNumAtRisk': 54, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Incision Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'seriousEvents': [{'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'GI hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Oesophagectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Spinal laminectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Adrenocortical Insufficiency Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Suture Related Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Kidney transplant rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Renal Cell Carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Laparotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'Thyroidectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 55, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 54, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postoperative Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Inguinal Arm - AbsorbaTack', 'description': 'Inguinal hernia study arm with AbsorbaTack as treatment.'}, {'id': 'OG001', 'title': 'Inguinal Arm - ProTack', 'description': 'Inguinal hernia study arm with ProTack as treatment.'}, {'id': 'OG002', 'title': 'Ventral Arm - Absorbatack'}, {'id': 'OG003', 'title': 'Ventral Arm - ProTack'}], 'classes': [{'title': 'Change from baseline - discharge', 'categories': [{'measurements': [{'value': '.8', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '2.2', 'spread': '3.8', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '3.6', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline - 1 month', 'categories': [{'measurements': [{'value': '-1.1', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '-.4', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '-.7', 'spread': '3.0', 'groupId': 'OG002'}, {'value': '.5', 'spread': '1.9', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline - 6 months', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '-.6', 'spread': '1.8', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '2.8', 'groupId': 'OG002'}, {'value': '-.6', 'spread': '1.7', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline - 1 year', 'categories': [{'measurements': [{'value': '-1.2', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '-.9', 'spread': '1.6', 'groupId': 'OG001'}, {'value': '-1.8', 'spread': '2.7', 'groupId': 'OG002'}, {'value': '-.8', 'spread': '1.8', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Discharge, Month 1, Month 6, Month 12', 'description': 'Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm.\n\nScale is 0 - 10 with 0 being "no pain" and 10 being "worst pain imaginable".', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '1 patient in the Ventral Arm - AbsorbaTack had only pre-operative pain scores available so was unable to be included in this analysis.'}, {'type': 'PRIMARY', 'title': 'Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Inguinal Arm - AbsorbaTack', 'description': 'Inguinal hernia study arm with AbsorbaTack as treatment.'}, {'id': 'OG001', 'title': 'Inguinal Arm - ProTack', 'description': 'Inguinal hernia study arm with ProTack as treatment.'}, {'id': 'OG002', 'title': 'Ventral Arm - Absorbatack'}, {'id': 'OG003', 'title': 'Ventral Arm - ProTack'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'One year', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Inguinal Arm - AbsorbaTack', 'description': 'Inguinal hernia study arm with AbsorbaTack as treatment.'}, {'id': 'OG001', 'title': 'Inguinal Arm - ProTack', 'description': 'Inguinal hernia study arm with ProTack as treatment.'}, {'id': 'OG002', 'title': 'Ventral Arm - Absorbatack'}, {'id': 'OG003', 'title': 'Ventral Arm - ProTack'}], 'classes': [{'title': 'Pre-Op', 'categories': [{'measurements': [{'value': '48.8', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '46.1', 'spread': '9.3', 'groupId': 'OG002'}, {'value': '49.0', 'spread': '9.1', 'groupId': 'OG003'}]}]}, {'title': '1 Month', 'categories': [{'measurements': [{'value': '49.1', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '50.2', 'spread': '7.0', 'groupId': 'OG001'}, {'value': '45.4', 'spread': '9.5', 'groupId': 'OG002'}, {'value': '45.2', 'spread': '9.0', 'groupId': 'OG003'}]}]}, {'title': '6 Month', 'categories': [{'measurements': [{'value': '55.3', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '54.4', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '51.6', 'spread': '9.4', 'groupId': 'OG002'}, {'value': '51.1', 'spread': '7.6', 'groupId': 'OG003'}]}]}, {'title': '1 year', 'categories': [{'measurements': [{'value': '55.8', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '53.8', 'spread': '6.0', 'groupId': 'OG001'}, {'value': '52.0', 'spread': '8.1', 'groupId': 'OG002'}, {'value': '53.3', 'spread': '6.6', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-op, Month 1, Month 6, 1 year', 'description': 'Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life.\n\nThe Physical Composite Score was computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participant # above reflects those at pre-op. Arms ended study with 34, 39, 36 and 39 subjects, respectively.'}, {'type': 'SECONDARY', 'title': 'Hernia Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Inguinal Arm - AbsorbaTack', 'description': 'Inguinal hernia study arm with AbsorbaTack as treatment.'}, {'id': 'OG001', 'title': 'Inguinal Arm - ProTack', 'description': 'Inguinal hernia study arm with ProTack as treatment.'}, {'id': 'OG002', 'title': 'Ventral Arm - Absorbatack'}, {'id': 'OG003', 'title': 'Ventral Arm - ProTack'}], 'classes': [{'title': 'Discharge', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '1 Month', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': '6 Month', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': '1 Year', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Discharge, 1 Month, 6 Month, 1 year', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inguinal Arm', 'description': 'Patients with inguinal hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.'}, {'id': 'FG001', 'title': 'Ventral Arm', 'description': 'Patients with ventral hernias are randomized to receive either AbsorbaTack or ProTack. The two treatments are compared within a single hernia type but not across hernia types.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '36'}]}]}], 'recruitmentDetails': 'Between November 4, 2008 and November 4, 2010, 117 subjects signed informed consent for the inguinal hernia arm of the study and 113 for the ventral arm. Of those subjects who consented, 106 and 110 were randomized to a treatment group (either AbsorbaTack™ or ProTack™) for inguinal and ventral hernia repair, respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '214', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Inguinal Arm - AbsorbaTack', 'description': 'Inguinal hernia study arm with AbsorbaTack as treatment.'}, {'id': 'BG001', 'title': 'Inguinal Arm - ProTack', 'description': 'Inguinal hernia study arm with ProTack as treatment.'}, {'id': 'BG002', 'title': 'Ventral Arm - Absorbatack', 'description': 'Ventral hernia study arm with AbsorbaTack as treatment.'}, {'id': 'BG003', 'title': 'Ventral Arm - ProTack', 'description': 'Ventral hernia study arm with ProTack as treatment.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.6', 'spread': '15.5', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '12.3', 'groupId': 'BG001'}, {'value': '50.3', 'spread': '11.3', 'groupId': 'BG002'}, {'value': '53.8', 'spread': '12.9', 'groupId': 'BG003'}, {'value': '51.49', 'spread': '13.15', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '159', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '1 inguinal pt assigned to receive AbsorbaTack was treated with ProTack and one patient assigned to receive ProTack received AbsorbaTack. These patients are included in the "intent to treat" population above, but were omitted from the safety population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 216}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-09', 'studyFirstSubmitDate': '2008-09-08', 'resultsFirstSubmitDate': '2013-10-14', 'studyFirstSubmitQcDate': '2008-09-08', 'lastUpdatePostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-09', 'studyFirstPostDateStruct': {'date': '2008-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain', 'timeFrame': 'Discharge, Month 1, Month 6, Month 12', 'description': 'Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm.\n\nScale is 0 - 10 with 0 being "no pain" and 10 being "worst pain imaginable".'}, {'measure': 'Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': 'Pre-op, Month 1, Month 6, 1 year', 'description': 'Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life.\n\nThe Physical Composite Score was computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.'}, {'measure': 'Hernia Recurrence', 'timeFrame': 'Discharge, 1 Month, 6 Month, 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hernia'], 'conditions': ['Hernia, Inguinal', 'Hernia, Ventral']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. The study is designed to see if there is any difference in pain after surgery between absorbable and permanent methods of mesh fixation in inguinal and ventral hernia repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability and willingness to provide written informed consent and comply with the schedule of protocol assessments\n* Age \\> 18 years\n* Subjects undergoing laparoscopic hernia repair with Parietex or Parietex Composite reinforcements depending on indication and fixation of reinforcements with helical tackers (ProTack, Covidien) or absorbable tacks (AbsorbaTack, Covidien) in accordance with recommendations for use\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients considered to have greater than reasonable surgical risk associated with general anesthesia and laparoscopic hernia repair\n* Known active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics within 30 days prior to screening\n* History of alcohol or drug abuse within 6 months prior to screening\n* History of chronic pain condition requiring more than 30 days of medical management\n* Use of an additional nonresorbable means of fixation (inguinal)\n* Patients considered not able to comply with the protocol and follow up schedule\n* ASA grade of 4 or above'}, 'identificationModule': {'nctId': 'NCT00749268', 'briefTitle': 'AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair: A Prospective, Randomized Comparison to Evaluate the Incidence of Post-operative Pain Associated With Absorbable Fixation (AbsorbaTack) vs Conventional Fixation (ProTack) Following Laparoscopic Hernia Repair', 'orgStudyIdInfo': {'id': 'AS08011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'interventionNames': ['Device: AbsorbaTack']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'interventionNames': ['Device: ProTack']}], 'interventions': [{'name': 'AbsorbaTack', 'type': 'DEVICE', 'description': 'Comparison of different devices for mesh fixation. This intervention arm has absorbable tacks as the method of hernia mesh fixation. Application is during hernia repair and tacks will essentially absorb within the body after 1 year.', 'armGroupLabels': ['A']}, {'name': 'ProTack', 'type': 'DEVICE', 'description': 'Comparison of different devices for mesh fixation. This intervention is a permanent tack for hernia mesh fixation. Application is during hernia repair and the tacks will remain in the body.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44194', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals at Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Hospital System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'M Rosen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Medical Center, University Hospitals of Cleveland, Cleveland, OH, USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}