Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap

NCT ID: NCT04493801

Last Updated: 2020-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-23

Study Completion Date

2022-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery--Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

with nasoseptal flap

patient who undergo a pituitary gland surgery with nasoseptal flap

No interventions assigned to this group

without nasoseptal flap

patient who undergo a pituitary gland surgery without nasoseptal flap

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHRU de Brest

Brest, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Emmanuel Mornet

Role: CONTACT

330298223004

Romuald seizeur

Role: CONTACT

330298342585

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Emmanuel MORNET

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HLNS ( 29BRC18.0257)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Female LUTS and Quality of Life
NCT04547933 COMPLETED