Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01920958
Status:
COMPLETED
Last Update Posted:
2016-12-19
First Post:
2013-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Use of Tachosil® for Lymph Sealing During Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C518955', 'term': 'TachoSil'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialregistry@tpna.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director, Clinical Science', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days', 'description': 'At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.', 'otherNumAtRisk': 228, 'otherNumAffected': 25, 'seriousNumAtRisk': 228, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 228, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.63', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 50 Days', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population consisted of all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery.'}, {'type': 'SECONDARY', 'title': 'Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '0.98', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Peri- and post-surgery (Up to 50 Days)', 'description': 'The surgeon evaluated handling of TachoSil® using a 10-point scale where: 1=very good to 10=very poor.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.25', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Peri- and post-surgery (Up to 50 Days)', 'description': 'The surgeon evaluated Utility in Operation of TachoSil® using a 10-point scale where: 1=very useful to 10=completely useless.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'spread': '1.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Peri- and post-surgery (Up to 50 Days)', 'description': 'The surgeon evaluated Satisfaction in Operation of TachoSil® using a 10-point scale where: 1=very satisfied to 10=totally unsatisfied.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One Drainage Inserted', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day of Surgery)', 'description': 'The total number of participants where at least one drainage was used during the operation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'classes': [{'title': 'Change in Length of Drainage Stay', 'categories': [{'measurements': [{'value': '48.65', 'groupId': 'OG000'}]}]}, {'title': 'Change in Drainage Volume', 'categories': [{'measurements': [{'value': '57.84', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 50 Days', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Length of Hospital and ICU Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'classes': [{'title': 'Hospital Stay (n=225)', 'categories': [{'measurements': [{'value': '12.2', 'spread': '6.57', 'groupId': 'OG000'}]}]}, {'title': 'ICU Stay (n=100)', 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 50 Days', 'description': 'Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants from the Intent-to-treat population (all participants who received patient information, signed consent and had Tachosil® applied during lymph node surgery) with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.98', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Peri- and post-surgery (Up to 50 Days)', 'description': 'Pharmacoeconomic benefit was assessed by the surgeon based on savings/shortening of operating time in minutes.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.19', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 50 Days', 'description': 'Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of hospital stay in days.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.77', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 50 Days', 'description': 'Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of time spent in ICU in days.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.96', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 50 Days', 'description': 'Pharmacoeconomic evaluation as assessed by the surgeon at hospital discharge based on drainage time reduced in days.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.04', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 50 Days', 'description': 'Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on the drainage volume reduced in milliliters.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Post-Operative Complications and Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'classes': [{'title': 'Postoperative Complications', 'categories': [{'measurements': [{'value': '18.42', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Events', 'categories': [{'measurements': [{'value': '13.60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 50 Days', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population consisted of all patients who received patient information and consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Intent-to-Treat (ITT) Population', 'groupId': 'FG000', 'numSubjects': '228'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Did Not Fulfill Inclusion Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'The study was conducted at 39 investigative sites in Germany from 30 September 2012 to 27 March 2014.', 'preAssignmentDetails': 'Collection of information of routine use of TachoSil® in participants who had lymph node surgery.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.6', 'spread': '10.82', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age data was available for 226 participants.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '110', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '228', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '169.9', 'spread': '9.07', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Height data was available for 216 participants.', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '79.6', 'spread': '15.84', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Weight data was available for 216 participants.', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '27.55', 'spread': '5.092', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'BMI data was available for 216 participants.', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'ITT population consisted of all patients who received patient information and who consented to the collection, transmission and evaluation of their data and who underwent lymph node resection with TachoSil®.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2013-07-19', 'resultsFirstSubmitDate': '2015-05-07', 'studyFirstSubmitQcDate': '2013-08-08', 'lastUpdatePostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-26', 'studyFirstPostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Post-Operative Seroma Formation Over Time as Determined at Hospital Discharge', 'timeFrame': 'Up to 50 Days'}], 'secondaryOutcomes': [{'measure': 'Assessment of TachoSil® by the Surgeon With Respect to Handling Using a 10-Point Numerical Rating Scale', 'timeFrame': 'Peri- and post-surgery (Up to 50 Days)', 'description': 'The surgeon evaluated handling of TachoSil® using a 10-point scale where: 1=very good to 10=very poor.'}, {'measure': 'Assessment of TachoSil® by the Surgeon With Respect to Utility in Operation Using a 10-Point Numerical Rating Scale', 'timeFrame': 'Peri- and post-surgery (Up to 50 Days)', 'description': 'The surgeon evaluated Utility in Operation of TachoSil® using a 10-point scale where: 1=very useful to 10=completely useless.'}, {'measure': 'Assessment of TachoSil® by the Surgeon With Respect to Satisfaction Using a 10-Point Numerical Rating Scale', 'timeFrame': 'Peri- and post-surgery (Up to 50 Days)', 'description': 'The surgeon evaluated Satisfaction in Operation of TachoSil® using a 10-point scale where: 1=very satisfied to 10=totally unsatisfied.'}, {'measure': 'Percentage of Participants With at Least One Drainage Inserted', 'timeFrame': 'Baseline (Day of Surgery)', 'description': 'The total number of participants where at least one drainage was used during the operation.'}, {'measure': 'Percentage of Participants With Change in Length of Drainage Stay and Drainage Volume', 'timeFrame': 'Up to 50 Days'}, {'measure': 'Length of Hospital and ICU Stay', 'timeFrame': 'Up to 50 Days', 'description': 'Length of stay includes time (days) spent in the intensive care unit (ICU) and normal hospital station.'}, {'measure': 'Percentage of Participants With Pharmacoeconomic Benefit Based on Savings of Operating Time', 'timeFrame': 'Peri- and post-surgery (Up to 50 Days)', 'description': 'Pharmacoeconomic benefit was assessed by the surgeon based on savings/shortening of operating time in minutes.'}, {'measure': 'Percentage of Participants With Pharmacoeconomic Benefit Based on Shortening of Hospital Stay', 'timeFrame': 'Up to 50 Days', 'description': 'Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of hospital stay in days.'}, {'measure': 'Percentage of Participants With Pharmacoeconomic Benefit in Shortening of Time Spent in ICU', 'timeFrame': 'Up to 50 Days', 'description': 'Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on shortening of time spent in ICU in days.'}, {'measure': 'Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Time Reduced', 'timeFrame': 'Up to 50 Days', 'description': 'Pharmacoeconomic evaluation as assessed by the surgeon at hospital discharge based on drainage time reduced in days.'}, {'measure': 'Percentage of Participants With Pharmacoeconomic Benefit Based on Drainage Volume Reduced', 'timeFrame': 'Up to 50 Days', 'description': 'Pharmacoeconomic benefit was assessed by the surgeon at hospital discharge based on the drainage volume reduced in milliliters.'}, {'measure': 'Percentage of Participants With Post-Operative Complications and Adverse Events', 'timeFrame': 'Up to 50 Days', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lymph Node Resection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to describe effectiveness and reliability of TachoSil® in lymph sealing after lymphadenectomy.', 'detailedDescription': 'The aim of this non-interventional study (NIS) was to collect further knowledge on the routine use of TachoSil ® in lymph node surgery where its sealing property helps to reduce the rate of postoperative complications, especially of seroma formation. Some data are already available from gynecology, urology and thoracic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Stationary patients in whom a lymph node resection was planned to be performed', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stationary patients undergoing lymph node resection.\n\nExclusion Criteria:\n\n* Contraindications, such as hypersensitivity to the active pharmaceutical ingredient or to another ingredient.'}, 'identificationModule': {'nctId': 'NCT01920958', 'acronym': 'SEAL', 'briefTitle': 'Use of Tachosil® for Lymph Sealing During Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Use of Tachosil® for Lymph Sealing During Surgery. A Non-Interventional Study', 'orgStudyIdInfo': {'id': 'TC-2402-401-DE'}, 'secondaryIdInfos': [{'id': 'U1111-1142-0279', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'TachoSil®', 'description': 'TachoSil®, sterile absorbable patch, topical application, used during surgery in participants who had lymphadenectomy according to the Summary of Product Characteristics.', 'interventionNames': ['Other: TachoSil®']}], 'interventions': [{'name': 'TachoSil®', 'type': 'OTHER', 'description': 'TachoSil® is a collagen sponge that is coated with the active substances human fibrinogen and human thrombin and that supports hemostasis and tissue sealing in surgery.', 'armGroupLabels': ['TachoSil®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Greifswald', 'country': 'Germany', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda Pharma Vertrieb GmbH & Co. KG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}