Clinical trial NCT04951557: Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas
Official title: Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas - An Analysis of Standardized Outcome References From an International Multicentre Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pituitary Adenoma
Pituitary Tumor
Pituitary Diseases
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2021-07-07
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who went through transsphenoidal resection of pituitary adenoma at high-volume centres

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Reoperation
timeFrame: up to two weeks
measure: CSF leak
timeFrame: up to two weeks
measure: Epistaxis
timeFrame: up to two weeks
measure: Meningitis
timeFrame: up to two weeks
measure: Diabetes insipidus
timeFrame: up to two weeks
measure: SIADH
timeFrame: up to two weeks
measure: Cerebral vasospasm
timeFrame: up to two weeks
measure: New hypopituitarism
timeFrame: up to two weeks
measure: Normalization of hormone levels
timeFrame: up to two weeks
measure: New neurological deficit
timeFrame: up to two weeks
measure: Postoperative change of vision
timeFrame: up to two weeks
measure: Need for ICU care
timeFrame: up to two weeks
measure: Length of stay
timeFrame: up to two weeks
measure: In-hospital mortality
timeFrame: up to two weeks
measure: Readmission to hospital
timeFrame: At 6 months follow up
measure: Electrolyte imbalance
timeFrame: At 6 months follow up
measure: New hypopituitarism
timeFrame: At 6 months follow up
measure: New neurological deficit
timeFrame: At 6 months follow up
measure: CSF leak
timeFrame: At 6 months follow up
measure: Termination of hypersecretion
timeFrame: At 6 months follow up
measure: MRI resection control
timeFrame: At 6 months follow up
Secondary outcomes:
Other outcomes:
measure: Age
timeFrame: At time of surgery
measure: Gender
timeFrame: At time of surgery
measure: Body mass index
timeFrame: At time of surgery
measure: ASA score
timeFrame: At time of surgery
measure: Hormone replacement
timeFrame: At time of surgery
measure: Neurological deficit
timeFrame: At time of surgery
measure: Previous therapy
timeFrame: At time of surgery
measure: Tumour size
timeFrame: At time of surgery
measure: Knosp grade
timeFrame: At time of surgery
measure: Tumour extension
timeFrame: At time of surgery
measure: Histology
timeFrame: At time of surgery
measure: Operating method
timeFrame: Surgery
measure: Operating duration
timeFrame: Surgery
measure: Gross total resection
timeFrame: Surgery
measure: Blood transfusion
timeFrame: Surgery
measure: Repair of CSF leak
timeFrame: Surgery
measure: Nasal tamponade
timeFrame: Surgery
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Richard Drexler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Franz L Ricklefs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Jörg Flitsch, MD
role: STUDY_CHAIR
References: