NCT04951557

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 7, 2021

Status Verified

June 1, 2021

Enrollment Period

2.9 years

First QC Date

June 17, 2021

Last Update Submit

June 30, 2021

Conditions

Pituitary AdenomaPituitary TumorPituitary Diseases

Outcome Measures

Primary Outcomes (21)

  • 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 Outcomes (17)

  • Age

    At time of surgery

  • Gender

    At time of surgery

  • Body mass index

    At time of surgery

  • +14 more other outcomes

Interventions

Transsphenoidal resectionPROCEDURE

Transsphenoidal resection of pituitary adenoma

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Pituitary NeoplasmsPituitary Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesEndocrine System Diseases

Study Officials

  • Richard Drexler, MD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

  • Franz L Ricklefs, MD

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

  • Jörg Flitsch, MD

    Universitätsklinikum Hamburg-Eppendorf

    STUDY CHAIR

Central Study Contacts

Richard Drexler, MD

CONTACT

004915222816461r.drexler@uke.de

Jörg Flitsch, MD

CONTACT

flitsch@uke.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 17, 2021

First Posted

July 7, 2021

Study Start

January 31, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2022

Last Updated

July 7, 2021

Record last verified: 2021-06

Locations

DE(1)