Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas - An Analysis of Standardized Outcome References From an International Multicentre Cohort

Conditions
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Pituitary Adenoma, Pituitary Tumor, Pituitary Diseases

Intervention / Treatment
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* Procedure: Transsphenoidal resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who went through transsphenoidal resection of pituitary adenoma Including high-volume centres with ≥50 cases per year Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transsphenoidal resection|Transsphenoidal resection of pituitary adenoma|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 |