Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas - An Analysis of Standardized Outcome References From an International Multicentre Cohort
试验速览
- 阶段
- 不适用
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Meningitis
研究概览
简要总结
To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following transsphenoidal resection of pituitary adenomas.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who went through transsphenoidal resection of pituitary adenoma
- •Including high-volume centres with ≥50 cases per year
排除标准
- 未提供
结局指标
主要结局
Meningitis
时间窗: up to two weeks
New neurological deficit
时间窗: At 6 months follow up
CSF leak
时间窗: At 6 months follow up
Requiring intervention
Diabetes insipidus
时间窗: up to two weeks
SIADH
时间窗: up to two weeks
Postoperative change of vision
时间窗: up to two weeks
Need for ICU care
时间窗: up to two weeks
Readmission to hospital
时间窗: At 6 months follow up
Related to transsphenoidal surgery
Electrolyte imbalance
时间窗: At 6 months follow up
Requiring drug treatment
Termination of hypersecretion
时间窗: At 6 months follow up
If applicable
Reoperation
时间窗: up to two weeks
Epistaxis
时间窗: up to two weeks
Requiring intervention
Normalization of hormone levels
时间窗: up to two weeks
Length of stay
时间窗: up to two weeks
In-hospital mortality
时间窗: up to two weeks
MRI resection control
时间窗: At 6 months follow up
If applicable
Cerebral vasospasm
时间窗: up to two weeks
New hypopituitarism
时间窗: At 6 months follow up
Requiring hormone replacement
次要结局
未报告次要终点
研究者
Richard Drexler
Principal Investigator
Universitätsklinikum Hamburg-Eppendorf
