Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas

Pituitary Adenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04951557
• Other study ID #: Benchpit
• Status: Recruiting
• Start date: January 31, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Richard Drexler, MD
• Phone: 004915222816461
• Email: r.drexler[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following transsphenoidal resection of pituitary adenomas.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who went through transsphenoidal resection of pituitary adenoma

• Including high-volume centres with =50 cases per year

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor

Intervention

Procedure:
• Transsphenoidal resection
Transsphenoidal resection of pituitary adenoma

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Brigham and Women's Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age		At time of surgery
Other	Gender		At time of surgery
Other	Body mass index		At time of surgery
Other	ASA score		At time of surgery
Other	Hormone replacement		At time of surgery
Other	Neurological deficit		At time of surgery
Other	Previous therapy	None, transsphenoidal surgery, pharmacotherapy, radiotherapy	At time of surgery
Other	Tumour size	Microadenoma, Macroadenoma	At time of surgery
Other	Knosp grade		At time of surgery
Other	Tumour extension	Intraventricular extension, sinus cavernous invasion	At time of surgery
Other	Histology	According to 2017 WHO classification	At time of surgery
Other	Operating method	Endoscopy, microscopy, 3D-video microscopy, hybrid	Surgery
Other	Operating duration	minutes	Surgery
Other	Gross total resection		Surgery
Other	Blood transfusion		Surgery
Other	Repair of CSF leak	None, muscle/fascial patch, fibrin alone, mucosal flap, fat, other technique	Surgery
Other	Nasal tamponade		Surgery
Primary	Reoperation		up to two weeks
Primary	CSF leak	Requiring intervention	up to two weeks
Primary	Epistaxis	Requiring intervention	up to two weeks
Primary	Meningitis		up to two weeks
Primary	Diabetes insipidus		up to two weeks
Primary	SIADH		up to two weeks
Primary	Cerebral vasospasm		up to two weeks
Primary	New hypopituitarism	Requiring hormone replacement	up to two weeks
Primary	Normalization of hormone levels		up to two weeks
Primary	New neurological deficit		up to two weeks
Primary	Postoperative change of vision		up to two weeks
Primary	Need for ICU care		up to two weeks
Primary	Length of stay		up to two weeks
Primary	In-hospital mortality		up to two weeks
Primary	Readmission to hospital	Related to transsphenoidal surgery	At 6 months follow up
Primary	Electrolyte imbalance	Requiring drug treatment	At 6 months follow up
Primary	New hypopituitarism	Requiring hormone replacement	At 6 months follow up
Primary	New neurological deficit		At 6 months follow up
Primary	CSF leak	Requiring intervention	At 6 months follow up
Primary	Termination of hypersecretion	If applicable	At 6 months follow up
Primary	MRI resection control	If applicable	At 6 months follow up