Nasal SurgeryNCT01945502
Nasopharyngeal Packing and Rhinologic Surgery.
An observational study of Nasal Surgery and Tampons, run by Basak Ceyda MECO at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to assess the efficacy of three different pharyngeal packing during routine rhinologic surgery in the prevention of postoperative nausea and vomiting, and to evaluate the influence of pharyngeal packing on postoperative throat pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nasal Surgery, Tampons, PONV
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2013to Dec 2013
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult patients (18-60 years) scheduled for routine nasal and/or paranasal sinus surgeries in Ankara Univerity Faculty of Medicine, ETN operating rooms were recruited into this study.
Who may be able to join
- 18-60 years old adult patient
- nasal and/or paranasal sinus surgeries
- general anesthesia
Who cannot join
- patients submitted to another intervention at the same time (adenoidectomy, tonsillectomy)
- patients with a serious systemic disease (acquired immunodeficiency syndrome,leukemia, lymphoma, or other neoplasias under chemotherapy treatment)
- patients presenting contraindications for using nonsteroid anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University Faculty of Medicine ENT operating rooms
Ankara, 06100
Basak Ceyda MECO, MD, DESA, 0090 532 4179911, basakceyda@hotmail.com
About this study
Official title: The Effectiveness of Three Different Nasopharyngeal Packing on the Prevention of Postoperative Nausea- Vomiting and Postoperative Throat Pain in Rhinologic Surgery.
The purpose of this study is to assess the efficacy of three different pharyngeal packing during routine rhinologic surgery in the prevention of postoperative nausea and vomiting, and to evaluate the influence of pharyngeal packing on postoperative throat pain.
- Conditions
- Nasal Surgery, Tampons, PONV
- Medical subject headings
- Postoperative Nausea and Vomiting
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 |
|---|---|---|
| nasal packing with dry packs | Not described | |
| nasal packing with wet packs | Not described | |
| nasal packing with Benzidamin-Clorhexsidin damped packs | Not described | |
| no nasal packing | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea vomiting
Measured: 3 months
sore throat
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal SurgeryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basak Ceyda MECO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Basak Ceyda MECO, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945502
- Sponsor's protocol ID
- 11-434-13
- Status last verified
- Sep 2013
- First submitted
- 16 Sep 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Three Different Nasopharyngeal Packing on the Prevention of Postoperative Nausea- Vomiting and Postoperative Throat Pain in Rhinologic Surgery.
- ClinicalTrials.gov ID
- NCT01945502
- Acronym / sponsor ID
- 11-434-13
- Conditions
- Nasal Surgery, Tampons, PONV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Basak Ceyda MECOUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (estimated)
- First posted
- 18 Sep 2013 (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.
The purpose of this study is to assess the efficacy of three different pharyngeal packing during routine rhinologic surgery in the prevention of postoperative nausea and vomiting, and to evaluate the influence of pharyngeal packing on postoperative throat pain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| nasal packing with dry packs | – | – |
| nasal packing with wet packs | – | – |
| nasal packing with Benzidamin-Clorhexsidin damped packs | – | – |
| no nasal packing | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult patients (18-60 years) scheduled for routine nasal and/or paranasal sinus surgeries in Ankara Univerity Faculty of Medicine, ETN operating rooms were recruited into this study.
Key inclusion criteria (3 listed)
- 18-60 years old adult patient
- nasal and/or paranasal sinus surgeries
- general anesthesia
Key exclusion criteria (3 listed)
- patients submitted to another intervention at the same time (adenoidectomy, tonsillectomy)
- patients with a serious systemic disease (acquired immunodeficiency syndrome,leukemia, lymphoma, or other neoplasias under chemotherapy treatment)
- patients presenting contraindications for using nonsteroid anti-inflammatory drugs
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
Postoperative nausea vomiting
Time frame: 3 months
sore throat
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
Related trials for Nasal Surgery
Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps
Not yet recruitingObservational study
Oral Mucosal Grafting for Nasal Septal Perforation Repair
Nasal Septal Perforation
Recruiting
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Not yet recruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
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.
Ankara University Faculty of Medicine ENT operating rooms
Ankara, Turkey (Türkiye)
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 Nasal Surgery and Tampons, run by Basak Ceyda MECO at 1 site in Turkey (Türkiye).
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 3 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 18 Sep 2013. 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 Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea vomiting (time frame: 3 months). 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 18 Sep 2013.