EpistaxisPhase 4NCT00793117
The Effect of Packing in Post Operative Management of FESS
A Phase 4 study testing packing in people with Epistaxis and Nasal Obstruction, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Chronic sinusitis is a very common problem. The functional endoscopic sinus surgery is a prevalent option to treat this disease.During usage of different techniques of surgery, the need for packing after surgery is debatable problem. So to solve this problem this research has been designed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epistaxis, Nasal Obstruction, Pain
- What is being tested?
- packing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteIran
- Study dates
- Nov 2008to Dec 2010
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with chronic sinusitis who candid of fess
Who cannot join
- Systemic disease
- Corticosteroid usage counterindication
- Immune suppresive usage
- Choncha bollusa resection-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Effect of Pva Sponge in Prevention of Complications in Fess
Chronic sinusitis is a very common problem. The functional endoscopic sinus surgery is a prevalent option to treat this disease.During usage of different techniques of surgery, the need for packing after surgery is debatable problem. So to solve this problem this research has been designed.
Read the detailed description
Chronic sinusitis is a very common problem. The functional endoscopic sinus surgery is a prevalent option to treat this disease.During usage of different techniques of surgery, the need for packing after surgery is debatable problem.
Someone claimed packing is unnecessary and other one propose different material to packing after surgery. So to solve this problem this research has been designed.
- Conditions
- Epistaxis, Nasal Obstruction, Pain
- Being tested
- packing
- Keywords
- chronic sinusitis, FESS, packing
- Medical subject headings
- Epistaxis, Nasal Obstruction, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
packingProcedure or surgery
packing in middle meatus for duration of 5 day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | poly vinil chloride packing Receives: Procedure: packing |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Babak Saedi, Tehran University of Medical Sciences
- Investigators
- babak saedi, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793117
- Sponsor's protocol ID
- BS-87-01-48-6841
- Other IDs
- 87-01-48-6844
- Status last verified
- Jun 2012
- First submitted
- 15 Nov 2008
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Effect of Pva Sponge in Prevention of Complications in Fess
- ClinicalTrials.gov ID
- NCT00793117
- Acronym / sponsor ID
- BS-87-01-48-6841
- Conditions
- Epistaxis, Nasal Obstruction, Pain
- Keywords
- chronic sinusitis, FESS, packing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Nov 2008 (estimated)
- 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.
Chronic sinusitis is a very common problem. The functional endoscopic sinus surgery is a prevalent option to treat this disease.During usage of different techniques of surgery, the need for packing after surgery is debatable problem. So to solve this problem this research has been designed.
Detailed description
Chronic sinusitis is a very common problem. The functional endoscopic sinus surgery is a prevalent option to treat this disease.During usage of different techniques of surgery, the need for packing after surgery is debatable problem.
Someone claimed packing is unnecessary and other one propose different material to packing after surgery. So to solve this problem this research has been designed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: packingpoly vinil chloride packing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with chronic sinusitis who candid of fess
Key exclusion criteria (4 listed)
- Systemic disease
- Corticosteroid usage counterindication
- Immune suppresive usage
- Choncha bollusa resection-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| packingpacking in middle meatus for duration of 5 day | Procedure or surgery | 1 |
Primary outcome
complication
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
Related trials for Epistaxis
Not yet recruitingPhase 1
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Hereditary Hemorrhagic Telangiectasia (HHT), Epistaxis
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia
Not yet recruitingPhase 2
Effect of Vitamin C Administration on Intraoperative Bleeding in Patients Undergoing Sinusoscopy
Chronic Rhinosinusitis, Intraoperative Bleeding
RecruitingObservational study
Comprehensive HHT Outcomes Registry of the United States (CHORUS)
Hereditary Hemorrhagic Telangiectasia, Arteriovenous Malformations
Recruiting
Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia
Hereditary Hemorrhagic Telangiectasia, Rendu Osler Disease
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.
babak saedi principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing packing in people with Epistaxis and Nasal Obstruction, run by Tehran University of Medical Sciences at 1 site in Iran.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 5 Jun 2012. 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 Iran. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complication (time frame: 6 month). 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 5 Jun 2012; AzTrials last refreshed its copy on 8 Nov 2026.