Surgery--ComplicationsHLNSNCT04493801
Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap
An observational study of Surgery--Complications, run by University Hospital, Brest at 1 site in France.
Trial summary
Determine and compare prospectively the incidence of rhinological adverse events during pituitary surgery with or without nasoseptal flap Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jul 2019to Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who undergoing a pituary gland surgery
Who may be able to join
- to be over 18 years old
- to be operated on for pituitary surgery
- to have express no objection to the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Emmanuel MORNET, emmanuel.mornet@chu-brest.fr
About this study
Determine and compare prospectively the incidence of rhinological adverse events during pituitary surgery with or without nasoseptal flap
- Conditions
- Surgery--Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
post operative epistaxis
no epistaxis - begnin epistaxis - severe epistaxis.
Measured: during two month after surgery
post operative rhinoliquorrhea
physical examination and symptomatic rhinorrhea
Measured: during two month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start23 Jul 2019
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493801
- Sponsor's protocol ID
- HLNS ( 29BRC18.0257)
- Acronym
- HLNS
- Status last verified
- Jun 2020
- First submitted
- 28 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Rhinological Morbidities During Endonasal Pituitary Surgery, With or Without Nasoseptal Flap
- ClinicalTrials.gov ID
- NCT04493801
- Acronym / sponsor ID
- HLNS / HLNS ( 29BRC18.0257)
- Conditions
- Surgery--Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine and compare prospectively the incidence of rhinological adverse events during pituitary surgery with or without nasoseptal flap
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who undergoing a pituary gland surgery
Key inclusion criteria (3 listed)
- to be over 18 years old
- to be operated on for pituitary surgery
- to have express no objection to the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
post operative epistaxis
Time frame: during two month after surgery
no epistaxis - begnin epistaxis - severe epistaxis.
post operative rhinoliquorrhea
Time frame: during two month after surgery
physical examination and symptomatic rhinorrhea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel Mornet (330298223004, emmanuel.mornet@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative epistaxis (time frame: during two month after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.