Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:01 PM
Study NCT ID:
NCT04951557
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2021-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010911', 'term': 'Pituitary Neoplasms'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-30', 'studyFirstSubmitDate': '2021-06-17', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Age', 'timeFrame': 'At time of surgery'}, {'measure': 'Gender', 'timeFrame': 'At time of surgery'}, {'measure': 'Body mass index', 'timeFrame': 'At time of surgery'}, {'measure': 'ASA score', 'timeFrame': 'At time of surgery'}, {'measure': 'Hormone replacement', 'timeFrame': 'At time of surgery'}, {'measure': 'Neurological deficit', 'timeFrame': 'At time of surgery'}, {'measure': 'Previous therapy', 'timeFrame': 'At time of surgery', 'description': 'None, transsphenoidal surgery, pharmacotherapy, radiotherapy'}, {'measure': 'Tumour size', 'timeFrame': 'At time of surgery', 'description': 'Microadenoma, Macroadenoma'}, {'measure': 'Knosp grade', 'timeFrame': 'At time of surgery'}, {'measure': 'Tumour extension', 'timeFrame': 'At time of surgery', 'description': 'Intraventricular extension, sinus cavernous invasion'}, {'measure': 'Histology', 'timeFrame': 'At time of surgery', 'description': 'According to 2017 WHO classification'}, {'measure': 'Operating method', 'timeFrame': 'Surgery', 'description': 'Endoscopy, microscopy, 3D-video microscopy, hybrid'}, {'measure': 'Operating duration', 'timeFrame': 'Surgery', 'description': 'minutes'}, {'measure': 'Gross total resection', 'timeFrame': 'Surgery'}, {'measure': 'Blood transfusion', 'timeFrame': 'Surgery'}, {'measure': 'Repair of CSF leak', 'timeFrame': 'Surgery', 'description': 'None, muscle/fascial patch, fibrin alone, mucosal flap, fat, other technique'}, {'measure': 'Nasal tamponade', 'timeFrame': 'Surgery'}], 'primaryOutcomes': [{'measure': 'Reoperation', 'timeFrame': 'up to two weeks'}, {'measure': 'CSF leak', 'timeFrame': 'up to two weeks', 'description': 'Requiring intervention'}, {'measure': 'Epistaxis', 'timeFrame': 'up to two weeks', 'description': 'Requiring intervention'}, {'measure': 'Meningitis', 'timeFrame': 'up to two weeks'}, {'measure': 'Diabetes insipidus', 'timeFrame': 'up to two weeks'}, {'measure': 'SIADH', 'timeFrame': 'up to two weeks'}, {'measure': 'Cerebral vasospasm', 'timeFrame': 'up to two weeks'}, {'measure': 'New hypopituitarism', 'timeFrame': 'up to two weeks', 'description': 'Requiring hormone replacement'}, {'measure': 'Normalization of hormone levels', 'timeFrame': 'up to two weeks'}, {'measure': 'New neurological deficit', 'timeFrame': 'up to two weeks'}, {'measure': 'Postoperative change of vision', 'timeFrame': 'up to two weeks'}, {'measure': 'Need for ICU care', 'timeFrame': 'up to two weeks'}, {'measure': 'Length of stay', 'timeFrame': 'up to two weeks'}, {'measure': 'In-hospital mortality', 'timeFrame': 'up to two weeks'}, {'measure': 'Readmission to hospital', 'timeFrame': 'At 6 months follow up', 'description': 'Related to transsphenoidal surgery'}, {'measure': 'Electrolyte imbalance', 'timeFrame': 'At 6 months follow up', 'description': 'Requiring drug treatment'}, {'measure': 'New hypopituitarism', 'timeFrame': 'At 6 months follow up', 'description': 'Requiring hormone replacement'}, {'measure': 'New neurological deficit', 'timeFrame': 'At 6 months follow up'}, {'measure': 'CSF leak', 'timeFrame': 'At 6 months follow up', 'description': 'Requiring intervention'}, {'measure': 'Termination of hypersecretion', 'timeFrame': 'At 6 months follow up', 'description': 'If applicable'}, {'measure': 'MRI resection control', 'timeFrame': 'At 6 months follow up', 'description': 'If applicable'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pituitary Adenoma', 'Pituitary Tumor', 'Pituitary Diseases']}, 'descriptionModule': {'briefSummary': 'To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following transsphenoidal resection of pituitary adenomas.', 'detailedDescription': "Surgeons strive for the best possible outcome of their surgeries with the greatest possible chance for recovery of the patients. Therefore, monitoring and quality improvement is increasingly important in surgery. For this purpose, different concepts were developed with the aim to assess best achievable results for several surgical procedures and reduce unwarranted variation between different centers. The concept of a benchmark establishes reference values which represents the best possible outcome of high-volume centers and can be used for comparison and improvement. In the past years, the concept of benchmarking attaches greater importance in the field of healthcare, especially in surgery. Benchmark values are established within a patients' cohort for which the best possible outcome can be expected. To date, no valid concept exists to describe the outcome of patients after transsphenoidal resection of pituitary adenomas. The aim of our study is the establishment of robust and standardized outcome references after transsphenoidal surgery. After successful implantation of benchmarks from an international cohort of renowned centers, these data serve as reference values for the evaluation of novel surgical techniques and comparisons among centers or future clinical trials."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who went through transsphenoidal resection of pituitary adenoma at high-volume centres', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who went through transsphenoidal resection of pituitary adenoma\n* Including high-volume centres with ≥50 cases per year\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04951557', 'briefTitle': 'Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas - An Analysis of Standardized Outcome References From an International Multicentre Cohort', 'orgStudyIdInfo': {'id': 'Benchpit'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Transsphenoidal resection', 'type': 'PROCEDURE', 'description': 'Transsphenoidal resection of pituitary adenoma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Richard Drexler, MD', 'role': 'CONTACT', 'email': 'r.drexler@uke.de'}], 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'centralContacts': [{'name': 'Richard Drexler, MD', 'role': 'CONTACT', 'email': 'r.drexler@uke.de', 'phone': '004915222816461'}, {'name': 'Jörg Flitsch, MD', 'role': 'CONTACT', 'email': 'flitsch@uke.de'}], 'overallOfficials': [{'name': 'Richard Drexler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}, {'name': 'Franz L Ricklefs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}, {'name': 'Jörg Flitsch, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitätsklinikum Hamburg-Eppendorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Richard Drexler', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}