Pituitary Adenoma, Pituitary Diseases, Pituitary Tumor
Conditions
Brief summary
To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following transsphenoidal resection of pituitary adenomas.
Detailed description
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.
Interventions
PROCEDURETranssphenoidal resection
Transsphenoidal resection of pituitary adenoma
Sponsors
Brigham and Women's Hospital
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Patients who went through transsphenoidal resection of pituitary adenoma * Including high-volume centres with ≥50 cases per year
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI resection control | At 6 months follow up | If applicable |
| Reoperation | up to two weeks | — |
| CSF leak | up to two weeks | Requiring intervention |
| Epistaxis | up to two weeks | Requiring intervention |
| Meningitis | up to two weeks | — |
| Diabetes insipidus | up to two weeks | — |
| SIADH | up to two weeks | — |
| Cerebral vasospasm | up to two weeks | — |
| New hypopituitarism | up to two weeks | Requiring hormone replacement |
| Normalization of hormone levels | up to two weeks | — |
| New neurological deficit | up to two weeks | — |
| Postoperative change of vision | up to two weeks | — |
| 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 | At 6 months follow up | Related to transsphenoidal surgery |
| Electrolyte imbalance | At 6 months follow up | Requiring drug treatment |
| Termination of hypersecretion | At 6 months follow up | If applicable |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gender | At time of surgery | — |
| Body mass index | At time of surgery | — |
| ASA score | At time of surgery | — |
| Hormone replacement | At time of surgery | — |
| Neurological deficit | At time of surgery | — |
| Previous therapy | At time of surgery | None, transsphenoidal surgery, pharmacotherapy, radiotherapy |
| Tumour size | At time of surgery | Microadenoma, Macroadenoma |
| Knosp grade | At time of surgery | — |
| Tumour extension | At time of surgery | Intraventricular extension, sinus cavernous invasion |
| Histology | At time of surgery | According to 2017 WHO classification |
| Operating method | Surgery | Endoscopy, microscopy, 3D-video microscopy, hybrid |
| Operating duration | Surgery | minutes |
| Gross total resection | Surgery | — |
| Blood transfusion | Surgery | — |
| Repair of CSF leak | Surgery | None, muscle/fascial patch, fibrin alone, mucosal flap, fat, other technique |
| Nasal tamponade | Surgery | — |
| Age | At time of surgery | — |
Countries
Germany
Contacts
Primary ContactRichard Drexler, MD
Backup ContactJörg Flitsch, MD
Outcome results
None listed