Acute Recurrent RhinosinusitisNCT00184392
Cleaning of the Nose After Sinus Surgery: Necessary or Only Bothersome?
A study testing debridement or saline irrigation in people with Acute Recurrent Rhinosinusitis, run by Norwegian University of Science and Technology at 2 sites in Norway.
Trial summary
The goal of this study is to increase knowledge about how to treat patients after sinus surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Recurrent Rhinosinusitis
- What is being tested?
- debridement or saline irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2005to Sep 2007
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inclusion criteria are acute recurrent rhinosinusitis and chronic rhinosinusitis. The investigators used the classification of rhinosinusitis proposed by Lanza and Kennedy.
Who cannot join
- Previous FESS
- Systemic disease with affection of the nose (Wegener's granulomatosis, cystic fibrosis, Kartagener's syndrome, sarcoid)
- Primary ciliary dyskinesia
- Pregnancy
- Septoplasty in the same surgery
- Ongoing treatment for cancer
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Department of Otolaryngology, Sorlandet Hospital
Kristiansand, 4606
Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital of Trondheim, and Norwegian University of Science and Technology (NTNU), 7006 Trondheim, Norway
Trondheim, 7052
About this study
Official title: Debridement After Functional Endoscopic Sinus Surgery
The goal of this study is to increase knowledge about how to treat patients after sinus surgery.
Read the detailed description
Many surgeons consider the postoperative treatment after sinus surgery as important for the outcome as the surgery itself. However, postoperative treatment regimes differ considerably between surgeons. They include non-intervention, frequent in-office endoscopic debridement, stenting of the middle meatus, saline douching or irrigation of the nose, or combinations of these measures in various ways. The lack of consensus is unfortunate. It indicates a lack of knowledge about how to treat these patients optimally after surgery. This is partly due to a lack of internationally acknowledged randomised, comparative, prospective studies on the effects of the various postoperative measures and their interactions. Accordingly, some patients may receive a too intensive postoperative follow up, with unnecessary frequent visits with the doctor, unnecessary bleeding and inconvenience from unnecessary debridement/cleaning of the nose, and increased costs due to unnecessary medication. Conversely, there may be patients that receive too little attention in the postoperative period, and thus may have a suboptimal result of the operation.
Frequent cleaning/debridement of the nose after sinus surgery is believed to improve the outcome of functional endoscopic sinus surgery (FESS). However, the scientific data on its effects are limited. The purpose of this study was to evaluate the effects of cleaning/ debridement of the middle meatus 5-7 days and 12-14 days after sinus surgery in a randomized, partly blinded, controlled clinical trial.
- Conditions
- Acute Recurrent Rhinosinusitis
- Being tested
- debridement or saline irrigation
- Keywords
- Sinus surgery, endoscopic, postoperative care, debridement, randomized, acute recurrent rhinosinusitis, chronic rhinosinusitis, nasal polyps, Chronic rhinosinusitis with nasal polyps, Chronic rhinosinusitis without nasal polyps
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
debridement or saline irrigationProcedure or surgery
debridement of crusts, blood and secretions from the nose 1 week and 2 weeks after surgery
| Study group | Role | What they receive |
|---|---|---|
| debridement or saline irrigation | Experimental | 1 arm undergo debridement of the nose 1 week and 2 weeks after surgery the other arm rinse their nose with saline irrigation Receives: Procedure: debridement or saline irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesions in middle meatus or not
synechia between concha media and lateral nasal wall 0=no adhesion
1=adhesions present
Measured: 3 months
Secondary outcomes (5)
Pain due to cleaning of the nose
Pain on VAS
Measured: 1 and 2 weeks after surgery
Does cleaning of the nose reduce: crusts in the nose 14 days after surgery
0=no crusts
- =mild
- =impossible to see under concha media
Measured: 2 weeks after surgery
the tendency to post operative infections
Patient information connected to examination from the investigator
Measured: 3 months
Does debridement increase bleeding from the nose the first 14 days after surgery
0 no bleeding
- spots of blood
- bleeding from the nose
Measured: 2 weeks
nasal congestion after surgery
a patient diary, the patient mark nasal congestion on a VAS from day 1 to day 14 after surgery
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionDec 2005
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Recurrent RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Midt-Norge
- Responsible party
- Sponsor
- Investigators
- Vegard Bugten, M.D., Principal investigator, Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital of Trondheim, and Norwegian University of Science and Technology (NTNU), 7006 Trondheim, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184392
- Sponsor's protocol ID
- 229-04
- Status last verified
- Feb 2014
- First submitted
- 15 Sep 2005
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Bugten V, Nordgard S, Steinsvag S. The effects of debridement after endoscopic sinus surgery. Laryngoscope. 2006 Nov;116(11):2037-43. doi: 10.1097/01.mlg.0000241362.06072.83.
PubMed 17075402
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Debridement After Functional Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT00184392
- Acronym / sponsor ID
- 229-04
- Conditions
- Acute Recurrent Rhinosinusitis
- Keywords
- Sinus surgery, endoscopic, postoperative care, debridement, randomized, acute recurrent rhinosinusitis, chronic rhinosinusitis, nasal polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Helse Midt-Norge
- Study start
- Jan 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 16 Sep 2005 (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 goal of this study is to increase knowledge about how to treat patients after sinus surgery.
Detailed description
Many surgeons consider the postoperative treatment after sinus surgery as important for the outcome as the surgery itself. However, postoperative treatment regimes differ considerably between surgeons. They include non-intervention, frequent in-office endoscopic debridement, stenting of the middle meatus, saline douching or irrigation of the nose, or combinations of these measures in various ways. The lack of consensus is unfortunate. It indicates a lack of knowledge about how to treat these patients optimally after surgery. This is partly due to a lack of internationally acknowledged randomised, comparative, prospective studies on the effects of the various postoperative measures and their interactions. Accordingly, some patients may receive a too intensive postoperative follow up, with unnecessary frequent visits with the doctor, unnecessary bleeding and inconvenience from unnecessary debridement/cleaning of the nose, and increased costs due to unnecessary medication. Conversely, there may be patients that receive too little attention in the postoperative period, and thus may have a suboptimal result of the operation.
Frequent cleaning/debridement of the nose after sinus surgery is believed to improve the outcome of functional endoscopic sinus surgery (FESS). However, the scientific data on its effects are limited. The purpose of this study was to evaluate the effects of cleaning/ debridement of the middle meatus 5-7 days and 12-14 days after sinus surgery in a randomized, partly blinded, controlled clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| debridement or saline irrigation | Experimental | Procedure: debridement or saline irrigation1 arm undergo debridement of the nose 1 week and 2 weeks after surgery the other arm rinse their nose with saline irrigation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria are acute recurrent rhinosinusitis and chronic rhinosinusitis. The investigators used the classification of rhinosinusitis proposed by Lanza and Kennedy.
Key exclusion criteria (6 listed)
- Previous FESS
- Systemic disease with affection of the nose (Wegener's granulomatosis, cystic fibrosis, Kartagener's syndrome, sarcoid)
- Primary ciliary dyskinesia
- Pregnancy
- Septoplasty in the same surgery
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 |
|---|---|---|
| debridement or saline irrigationdebridement of crusts, blood and secretions from the nose 1 week and 2 weeks after surgery | Procedure or surgery | debridement or saline irrigation |
Primary outcome
Adhesions in middle meatus or not
Time frame: 3 months
synechia between concha media and lateral nasal wall 0=no adhesion 1=adhesions present
5 secondary outcomes
Pain due to cleaning of the nose
Time frame: 1 and 2 weeks after surgery
Does cleaning of the nose reduce: crusts in the nose 14 days after surgery
Time frame: 2 weeks after surgery
the tendency to post operative infections
Time frame: 3 months
Does debridement increase bleeding from the nose the first 14 days after surgery
Time frame: 2 weeks
nasal congestion after surgery
Time frame: 2 weeks
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 28 Feb 2014.
- Results publication: PubMed 17075402Bugten V, Nordgard S, Steinsvag S. The effects of debridement after endoscopic sinus surgery. Laryngoscope. 2006 Nov;116(11):2037-43. doi: 10.1097/01.mlg.0000241362.06072.83.
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.
Vegard Bugten, M.D. principal investigator
Department of Otolaryngology, Head and Neck Surgery, St Olav University Hospital of Trondheim, and Norwegian University of Science and Technology (NTNU), 7006 Trondheim, Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing debridement or saline irrigation in people with Acute Recurrent Rhinosinusitis, run by Norwegian University of Science and Technology at 2 sites in Norway.
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 6 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 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
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?
Adhesions in middle meatus or not (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00184392, which also lists 1 linked publication.
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 28 Feb 2014.