Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas
Rekrutierend
NCT-Nummer:
NCT04951557
Studienbeginn:
Januar 2017
Letztes Update:
07.07.2021
Wirkstoff:
-
Indikation (Clinical Trials):
Adenoma, Pituitary Neoplasms, Pituitary Diseases
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborator:
Brigham and Women's Hospital
Studienleiter
Richard Drexler, MD Principal InvestigatorUniversitätsklinikum Hamburg-Eppendorf
Franz L Ricklefs, MD Principal InvestigatorUniversitätsklinikum Hamburg-Eppendorf
Jörg Flitsch, MD Study ChairUniversitätsklinikum Hamburg-Eppendorf
Kontakt
Richard Drexler, MD Kontakt: Phone: 004915222816461 E-Mail: r.drexler@uke.de» Kontaktdaten anzeigen
Jörg Flitsch, MD Kontakt: E-Mail: flitsch@uke.de» Kontaktdaten anzeigen
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.
Inclusion Criteria: - Patients who went through transsphenoidal resection of pituitary adenoma - Including high-volume centres with ≥50 cases per yearExclusion Criteria: -
Primary outcome: 1. Reoperation (Time Frame - up to two weeks) 2. CSF leak (Time Frame - up to two weeks):Requiring intervention 3. Epistaxis (Time Frame - up to two weeks):Requiring intervention 4. Meningitis (Time Frame - up to two weeks) 5. Diabetes insipidus (Time Frame - up to two weeks) 6. SIADH (Time Frame - up to two weeks) 7. Cerebral vasospasm (Time Frame - up to two weeks) 8. New hypopituitarism (Time Frame - up to two weeks):Requiring hormone replacement 9. Normalization of hormone levels (Time Frame - up to two weeks) 10. New neurological deficit (Time Frame - up to two weeks) 11. Postoperative change of vision (Time Frame - up to two weeks) 12. Need for ICU care (Time Frame - up to two weeks) 13. Length of stay (Time Frame - up to two weeks) 14. In-hospital mortality (Time Frame - up to two weeks) 15. Readmission to hospital (Time Frame - At 6 months follow up):Related to transsphenoidal surgery 16. Electrolyte imbalance (Time Frame - At 6 months follow up):Requiring drug treatment 17. New hypopituitarism (Time Frame - At 6 months follow up):Requiring hormone replacement 18. New neurological deficit (Time Frame - At 6 months follow up) 19. CSF leak (Time Frame - At 6 months follow up):Requiring intervention 20. Termination of hypersecretion (Time Frame - At 6 months follow up):If applicable 21. MRI resection control (Time Frame - At 6 months follow up):If applicable
Transsphenoidal resection:Transsphenoidal resection of pituitary adenoma
Quelle: ClinicalTrials.gov
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