Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas

• Conditions: Pituitary Tumor; Pituitary Diseases; Pituitary Adenoma

• Registration Number: NCT04951557
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-01-31
• Primary Completion: 2019-12-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-30
• Last Update Submitted: 2021-06-30
• Study First Posted: 2021-07-07
• Last Update Posted: 2021-07-07
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Patients who went through transsphenoidal resection of pituitary adenoma
• Including high-volume centres with ≥50 cases per year

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Meningitis	up to two weeks
New neurological deficit	At 6 months follow up
CSF leak	At 6 months follow up	Requiring intervention
Diabetes insipidus	up to two weeks
Postoperative change of vision	up to two weeks
Need for ICU care	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
SIADH	up to two weeks
In-hospital mortality	up to two weeks
MRI resection control	At 6 months follow up	If applicable
Reoperation	up to two weeks
Epistaxis	up to two weeks	Requiring intervention
Normalization of hormone levels	up to two weeks
Length of stay	up to two weeks
Cerebral vasospasm	up to two weeks
New hypopituitarism	At 6 months follow up	Requiring hormone replacement

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany