Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap
HLNS
1 other identifier
observational
160
1 country
1
Brief Summary
Determine and compare prospectively the incidence of rhinological adverse events during pituitary surgery with or without nasoseptal flap
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 23, 2019
CompletedFirst Submitted
Initial submission to the registry
July 28, 2020
CompletedFirst Posted
Study publicly available on registry
July 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedJuly 30, 2020
June 1, 2020
2.7 years
July 28, 2020
July 28, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
post operative epistaxis
no epistaxis - begnin epistaxis - severe epistaxis.
during two month after surgery
post operative rhinoliquorrhea
physical examination and symptomatic rhinorrhea
during two month after surgery
Study Arms (2)
with nasoseptal flap
patient who undergo a pituitary gland surgery with nasoseptal flap
without nasoseptal flap
patient who undergo a pituitary gland surgery without nasoseptal flap
Eligibility Criteria
patients who undergoing a pituary gland surgery
You may qualify if:
- to be over 18 years old
- to be operated on for pituitary surgery
- to have express no objection to the study
You may not qualify if:
- refusal to participate in the study
- pregnant women
- to be Under the age of 18
- not being able to understand and accept participation in the study
- to have a life expectancy of less than a year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU de Brest
Brest, 29609, France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2020
First Posted
July 30, 2020
Study Start
July 23, 2019
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
July 30, 2020
Record last verified: 2020-06