Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04951557
Recruitment Status : Recruiting
First Posted : July 7, 2021
Last Update Posted : July 7, 2021
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Richard Drexler, Universitätsklinikum Hamburg-Eppendorf

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

Condition or disease Intervention/treatment
Pituitary Adenoma Pituitary Tumor Pituitary Diseases 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas - An Analysis of Standardized Outcome References From an International Multicentre Cohort
Actual Study Start Date : January 31, 2017
Actual Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Transsphenoidal resection
    Transsphenoidal resection of pituitary adenoma


Primary Outcome Measures :
  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


Other Outcome Measures:
  1. Age [ Time Frame: At time of surgery ]
  2. Gender [ Time Frame: At time of surgery ]
  3. Body mass index [ Time Frame: At time of surgery ]
  4. ASA score [ Time Frame: At time of surgery ]
  5. Hormone replacement [ Time Frame: At time of surgery ]
  6. Neurological deficit [ Time Frame: At time of surgery ]
  7. Previous therapy [ Time Frame: At time of surgery ]
    None, transsphenoidal surgery, pharmacotherapy, radiotherapy

  8. Tumour size [ Time Frame: At time of surgery ]
    Microadenoma, Macroadenoma

  9. Knosp grade [ Time Frame: At time of surgery ]
  10. Tumour extension [ Time Frame: At time of surgery ]
    Intraventricular extension, sinus cavernous invasion

  11. Histology [ Time Frame: At time of surgery ]
    According to 2017 WHO classification

  12. Operating method [ Time Frame: Surgery ]
    Endoscopy, microscopy, 3D-video microscopy, hybrid

  13. Operating duration [ Time Frame: Surgery ]
    minutes

  14. Gross total resection [ Time Frame: Surgery ]
  15. Blood transfusion [ Time Frame: Surgery ]
  16. Repair of CSF leak [ Time Frame: Surgery ]
    None, muscle/fascial patch, fibrin alone, mucosal flap, fat, other technique

  17. Nasal tamponade [ Time Frame: Surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients who went through transsphenoidal resection of pituitary adenoma at high-volume centres
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04951557


Contacts
Layout table for location contacts
Contact: Richard Drexler, MD 004915222816461 r.drexler@uke.de
Contact: Jörg Flitsch, MD flitsch@uke.de

Locations
Layout table for location information
Germany
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Richard Drexler, MD       r.drexler@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Brigham and Women's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Richard Drexler, MD Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Franz L Ricklefs, MD Universitätsklinikum Hamburg-Eppendorf
Study Chair: Jörg Flitsch, MD Universitätsklinikum Hamburg-Eppendorf
Layout table for additonal information
Responsible Party: Richard Drexler, Principal Investigator, Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT04951557    
Other Study ID Numbers: Benchpit
First Posted: July 7, 2021    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Brain Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Adenoma
Pituitary Diseases
Hypothalamic Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases