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

July 28, 2020 updated by: University Hospital, Brest
Determine and compare prospectively the incidence of rhinological adverse events during pituitary surgery with or without nasoseptal flap

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who undergoing a pituary gland surgery

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post operative epistaxis
Time Frame: during two month after surgery
no epistaxis - begnin epistaxis - severe epistaxis.
during two month after surgery
post operative rhinoliquorrhea
Time Frame: during two month after surgery
physical examination and symptomatic rhinorrhea
during two month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2019

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

July 28, 2020

First Submitted That Met QC Criteria

July 28, 2020

First Posted (Actual)

July 30, 2020

Study Record Updates

Last Update Posted (Actual)

July 30, 2020

Last Update Submitted That Met QC Criteria

July 28, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLNS ( 29BRC18.0257)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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