Pituitary Adenoma Clinical Trial
Official title:
Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas - An Analysis of Standardized Outcome References From an International Multicentre Cohort
To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following transsphenoidal resection of pituitary adenomas.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who went through transsphenoidal resection of pituitary adenoma - Including high-volume centres with =50 cases per year Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf | Brigham and Women's Hospital |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Age | At time of surgery | ||
Other | Gender | At time of surgery | ||
Other | Body mass index | At time of surgery | ||
Other | ASA score | At time of surgery | ||
Other | Hormone replacement | At time of surgery | ||
Other | Neurological deficit | At time of surgery | ||
Other | Previous therapy | None, transsphenoidal surgery, pharmacotherapy, radiotherapy | At time of surgery | |
Other | Tumour size | Microadenoma, Macroadenoma | At time of surgery | |
Other | Knosp grade | At time of surgery | ||
Other | Tumour extension | Intraventricular extension, sinus cavernous invasion | At time of surgery | |
Other | Histology | According to 2017 WHO classification | At time of surgery | |
Other | Operating method | Endoscopy, microscopy, 3D-video microscopy, hybrid | Surgery | |
Other | Operating duration | minutes | Surgery | |
Other | Gross total resection | Surgery | ||
Other | Blood transfusion | Surgery | ||
Other | Repair of CSF leak | None, muscle/fascial patch, fibrin alone, mucosal flap, fat, other technique | Surgery | |
Other | Nasal tamponade | Surgery | ||
Primary | Reoperation | up to two weeks | ||
Primary | CSF leak | Requiring intervention | up to two weeks | |
Primary | Epistaxis | Requiring intervention | up to two weeks | |
Primary | Meningitis | up to two weeks | ||
Primary | Diabetes insipidus | up to two weeks | ||
Primary | SIADH | up to two weeks | ||
Primary | Cerebral vasospasm | up to two weeks | ||
Primary | New hypopituitarism | Requiring hormone replacement | up to two weeks | |
Primary | Normalization of hormone levels | up to two weeks | ||
Primary | New neurological deficit | up to two weeks | ||
Primary | Postoperative change of vision | up to two weeks | ||
Primary | Need for ICU care | up to two weeks | ||
Primary | Length of stay | up to two weeks | ||
Primary | In-hospital mortality | up to two weeks | ||
Primary | Readmission to hospital | Related to transsphenoidal surgery | At 6 months follow up | |
Primary | Electrolyte imbalance | Requiring drug treatment | At 6 months follow up | |
Primary | New hypopituitarism | Requiring hormone replacement | At 6 months follow up | |
Primary | New neurological deficit | At 6 months follow up | ||
Primary | CSF leak | Requiring intervention | At 6 months follow up | |
Primary | Termination of hypersecretion | If applicable | At 6 months follow up | |
Primary | MRI resection control | If applicable | At 6 months follow up |
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