Pituitary AdenomaNCT04951557
Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas
An observational study of Pituitary Adenoma and Pituitary Tumor, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following transsphenoidal resection of pituitary adenomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Adenoma, Pituitary Tumor, Pituitary Diseases
- What is being tested?
- Transsphenoidal resection
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jan 2017to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients who went through transsphenoidal resection of pituitary adenoma at high-volume centres
Who may be able to join
- Patients who went through transsphenoidal resection of pituitary adenoma
- Including high-volume centres with ≥50 cases per year
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Jörg Flitsch, MD contact
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, 20246
Richard Drexler, MD, r.drexler@uke.de
About this study
Official title: 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.
Read the 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.
- Conditions
- Pituitary Adenoma, Pituitary Tumor, Pituitary Diseases
- Being tested
- Transsphenoidal resection
- Medical subject headings
- Pituitary Neoplasms, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transsphenoidal resectionProcedure or surgery
Transsphenoidal resection of pituitary adenoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Reoperation
Measured: up to two weeks
CSF leak
Requiring intervention
Measured: up to two weeks
Epistaxis
Requiring intervention
Measured: up to two weeks
Meningitis
Measured: up to two weeks
Diabetes insipidus
Measured: up to two weeks
SIADH
Measured: up to two weeks
Cerebral vasospasm
Measured: up to two weeks
New hypopituitarism
Requiring hormone replacement
Measured: up to two weeks
Normalization of hormone levels
Measured: up to two weeks
New neurological deficit
Measured: up to two weeks
Postoperative change of vision
Measured: up to two weeks
Need for ICU care
Measured: up to two weeks
Length of stay
Measured: up to two weeks
In-hospital mortality
Measured: up to two weeks
Readmission to hospital
Related to transsphenoidal surgery
Measured: At 6 months follow up
Electrolyte imbalance
Requiring drug treatment
Measured: At 6 months follow up
New hypopituitarism
Requiring hormone replacement
Measured: At 6 months follow up
New neurological deficit
Measured: At 6 months follow up
CSF leak
Requiring intervention
Measured: At 6 months follow up
Termination of hypersecretion
If applicable
Measured: At 6 months follow up
MRI resection control
If applicable
Measured: At 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start31 Jan 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Richard Drexler, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Richard Drexler, MD, Principal investigator, Universitätsklinikum Hamburg-EppendorfFranz L Ricklefs, MD, Principal investigator, Universitätsklinikum Hamburg-EppendorfJörg Flitsch, MD, Study chair, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951557
- Sponsor's protocol ID
- Benchpit
- Status last verified
- Jun 2021
- First submitted
- 17 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Setting Benchmarks for Transsphenoidal Resection of Pituitary Adenomas - An Analysis of Standardized Outcome References From an International Multicentre Cohort
- ClinicalTrials.gov ID
- NCT04951557
- Acronym / sponsor ID
- Benchpit
- Conditions
- Pituitary Adenoma, Pituitary Tumor, Pituitary Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who went through transsphenoidal resection of pituitary adenoma at high-volume centres
Key inclusion criteria (2 listed)
- Patients who went through transsphenoidal resection of pituitary adenoma
- Including high-volume centres with ≥50 cases per year
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transsphenoidal resectionTranssphenoidal resection of pituitary adenoma | Procedure or surgery | – |
Primary outcome
Reoperation
Time frame: up to two weeks
CSF leak
Time frame: up to two weeks
Requiring intervention
Epistaxis
Time frame: up to two weeks
Requiring intervention
Meningitis
Time frame: up to two weeks
Diabetes insipidus
Time frame: up to two weeks
SIADH
Time frame: up to two weeks
Cerebral vasospasm
Time frame: up to two weeks
New hypopituitarism
Time frame: up to two weeks
Requiring hormone replacement
Normalization of hormone levels
Time frame: up to two weeks
New neurological deficit
Time frame: up to two weeks
Postoperative change of vision
Time frame: up to two weeks
Need for ICU care
Time frame: up to two weeks
Length of stay
Time frame: up to two weeks
In-hospital mortality
Time frame: up to two weeks
Readmission to hospital
Time frame: At 6 months follow up
Related to transsphenoidal surgery
Electrolyte imbalance
Time frame: At 6 months follow up
Requiring drug treatment
New hypopituitarism
Time frame: At 6 months follow up
Requiring hormone replacement
New neurological deficit
Time frame: At 6 months follow up
CSF leak
Time frame: At 6 months follow up
Requiring intervention
Termination of hypersecretion
Time frame: At 6 months follow up
If applicable
MRI resection control
Time frame: At 6 months follow up
If applicable
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Flitsch, MD contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Adenoma and Pituitary Tumor, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard Drexler, MD (004915222816461, r.drexler@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reoperation (time frame: up to two weeks). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.