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临床试验/NCT04951557
NCT04951557Unknown不适用

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

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2017年1月31日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard Drexler

Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

研究点 (1)

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