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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following transsphenoidal resection of pituitary adenomas.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transsphenoidal resection | Procedure | Transsphenoidal resection of pituitary adenoma |
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation | up to two weeks | |
| CSF leak | Requiring intervention | up to two weeks |
| Epistaxis | Requiring intervention | up to two weeks |
| Meningitis | up to two weeks | |
| Diabetes insipidus | up to two weeks | |
| SIADH | up to two weeks | |
| Cerebral vasospasm | up to two weeks | |
| New hypopituitarism | Requiring hormone replacement | up to two weeks |
| Normalization of hormone levels | up to two weeks | |
| New neurological deficit | up to two weeks | |
| Postoperative change of vision | up to two weeks | |
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| Measure | Description | Time Frame |
|---|---|---|
| Age | At time of surgery | |
| Gender | At time of surgery | |
| Body mass index |
Inclusion Criteria:
Exclusion Criteria:
-
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Patients who went through transsphenoidal resection of pituitary adenoma at high-volume centres
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard Drexler, MD | Contact | 004915222816461 | r.drexler@uke.de | |
| Jörg Flitsch, MD | Contact | flitsch@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Richard Drexler, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Franz L Ricklefs, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| D010900 | Pituitary Diseases |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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| Need for ICU care |
| up to two weeks |
| Length of stay | up to two weeks |
| In-hospital mortality | up to two weeks |
| Readmission to hospital | Related to transsphenoidal surgery | At 6 months follow up |
| Electrolyte imbalance | Requiring drug treatment | At 6 months follow up |
| New hypopituitarism | Requiring hormone replacement | At 6 months follow up |
| New neurological deficit | At 6 months follow up |
| CSF leak | Requiring intervention | At 6 months follow up |
| Termination of hypersecretion | If applicable | At 6 months follow up |
| MRI resection control | If applicable | At 6 months follow up |
| At time of surgery |
| ASA score | At time of surgery |
| Hormone replacement | At time of surgery |
| Neurological deficit | At time of surgery |
| Previous therapy | None, transsphenoidal surgery, pharmacotherapy, radiotherapy | At time of surgery |
| Tumour size | Microadenoma, Macroadenoma | At time of surgery |
| Knosp grade | At time of surgery |
| Tumour extension | Intraventricular extension, sinus cavernous invasion | At time of surgery |
| Histology | According to 2017 WHO classification | At time of surgery |
| Operating method | Endoscopy, microscopy, 3D-video microscopy, hybrid | Surgery |
| Operating duration | minutes | Surgery |
| Gross total resection | Surgery |
| Blood transfusion | Surgery |
| Repair of CSF leak | None, muscle/fascial patch, fibrin alone, mucosal flap, fat, other technique | Surgery |
| Nasal tamponade | Surgery |
| Jörg Flitsch, MD |
| Universitätsklinikum Hamburg-Eppendorf |
| Study Chair |
| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D004700 | Endocrine System Diseases |