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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04493801
Other study ID # HLNS ( 29BRC18.0257)
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 23, 2019
Est. completion date April 2022

Study information

Verified date June 2020
Source University Hospital, Brest
Contact Emmanuel Mornet
Phone 330298223004
Email emmanuel.mornet@chu-brest.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Determine and compare prospectively the incidence of rhinological adverse events during pituitary surgery with or without nasoseptal flap


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date April 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- to be over 18 years old

- to be operated on for pituitary surgery

- to have express no objection to the study

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CHRU de Brest Brest

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary post operative epistaxis no epistaxis - begnin epistaxis - severe epistaxis. during two month after surgery
Primary post operative rhinoliquorrhea physical examination and symptomatic rhinorrhea during two month after surgery
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