JOURNAL ONKOLOGIE – STUDIE

Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

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 Investigator
Universitätsklinikum Hamburg-Eppendorf

Franz L Ricklefs, MD
Principal Investigator
Universitätsklinikum Hamburg-Eppendorf

Jörg Flitsch, MD
Study Chair
Universitätsklinikum 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

Studienlocations
(1 von 1)

University Medical Center Hamburg-Eppendorf
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Richard Drexler, MD
E-Mail: r.drexler@uke.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients who went through transsphenoidal resection of pituitary adenoma

- Including high-volume centres with ≥50 cases per year

Exclusion Criteria:

-

Studien-Rationale

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

Geprüfte Regime

Transsphenoidal resection:
Transsphenoidal resection of pituitary adenoma

Quelle: ClinicalTrials.gov

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