Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas

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

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

Study Overview

• Status: Recruiting
• Conditions: Pituitary Adenoma; Pituitary Diseases; Pituitary Tumor
• Intervention / Treatment: Procedure: Transsphenoidal resection

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.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Jörg Flitsch, MD; Email: flitsch@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Recruiting
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who went through transsphenoidal resection of pituitary adenoma at high-volume centres

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation		up to two weeks
CSF leak	Requiring intervention	up to two weeks
Epistaxis	Requiring intervention	up to two weeks
Meningitis		up to two weeks
Diabetes insipidus		up to two weeks
SIADH		up to two weeks
Cerebral vasospasm		up to two weeks
New hypopituitarism	Requiring hormone replacement	up to two weeks
Normalization of hormone levels		up to two weeks
New neurological deficit		up to two weeks
Postoperative change of vision		up to two weeks
Need for ICU care		up to two weeks
Length of stay		up to two weeks
In-hospital mortality		up to two weeks
Readmission to hospital	Related to transsphenoidal surgery	At 6 months follow up
Electrolyte imbalance	Requiring drug treatment	At 6 months follow up
New hypopituitarism	Requiring hormone replacement	At 6 months follow up
New neurological deficit		At 6 months follow up
CSF leak	Requiring intervention	At 6 months follow up
Termination of hypersecretion	If applicable	At 6 months follow up
MRI resection control	If applicable	At 6 months follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age		At time of surgery
Gender		At time of surgery
Body mass index		At time of surgery
ASA score		At time of surgery
Hormone replacement		At time of surgery
Neurological deficit		At time of surgery
Previous therapy	None, transsphenoidal surgery, pharmacotherapy, radiotherapy	At time of surgery
Tumour size	Microadenoma, Macroadenoma	At time of surgery
Knosp grade		At time of surgery
Tumour extension	Intraventricular extension, sinus cavernous invasion	At time of surgery
Histology	According to 2017 WHO classification	At time of surgery
Operating method	Endoscopy, microscopy, 3D-video microscopy, hybrid	Surgery
Operating duration	minutes	Surgery
Gross total resection		Surgery
Blood transfusion		Surgery
Repair of CSF leak	None, muscle/fascial patch, fibrin alone, mucosal flap, fat, other technique	Surgery
Nasal tamponade		Surgery

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Brigham and Women's Hospital
• Investigators: Principal Investigator: Franz L Ricklefs, MD, Universitätsklinikum Hamburg-Eppendorf; Study Chair: Jörg Flitsch, MD, Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: June 17, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: June 30, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Adenoma; Pituitary Neoplasms; Pituitary Diseases
• Other Study ID Numbers: Benchpit

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No