SinusitisNCT00534768
Postoperative Treatment After Endoscopic Sinus Surgery
A study testing active debridement in people with Sinusitis, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Objective: Even though postoperative debridement is commonly considered as an essential part of endoscopic sinus surgery (ESS), the scientific data on the efficacy or the optimal timing of debridement is limited. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sinusitis
- What is being tested?
- active debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteFinland
- Study dates
- Jan 2003to not given
- 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 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- A total of 90 patients (age 18-70 years), who underwent ESS in Kuopio University Hospital, Kuopio, Finland were included in this study.
- The patients suffered from either recurrent or chronic maxillary sinusitis and had American Society of Anaesthesiologists physical status 1 or 2.{{331 Sakland,M. 1941; }}
Who cannot join
- The patients were excluded if they had:
- Undergone previous sinus surgery or if they had severe nasal polyposis (radiological opacification more than 50 % of the sinuses (Lund-McKay classification)
- Hemorrhagic diathesis
- Liver or kidney dysfunction
- Chronic malnutrition
- Alcoholism or inflammatory bowel disease.
- Other exclusion criteria were pregnancy and ongoing anticoagulant therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Objective: Even though postoperative debridement is commonly considered as an essential part of endoscopic sinus surgery (ESS), the scientific data on the efficacy or the optimal timing of debridement is limited. In the present study, the effect of repeated debridement during the first week after ESS on the endoscopic and subjective outcome was evaluated.
Study Design: Open, prospective, randomized, controlled clinical trial with two parallel groups.
Methods: A total of 90 patients suffering from either recurrent or chronic maxillary sinusitis were randomized into two groups after ESS. In the active group, the nasal cavities were debrided three times on the first postoperative week, while in the control group the patients were debrided only once on the 7th postoperative day. The primary outcome measure was the presence of scarring in the middle meatus at four weeks after ESS.
- Conditions
- Sinusitis
- Being tested
- active debridement, control group
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active debridementProcedure or surgery
debridement on 1st, 3-5th and 7th postoperative days
control groupProcedure or surgery
Postoperative debridement on 7th postoperative day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | debridement on 1st, 3-5th and 7th postoperative days Receives: Procedure: active debridement |
| 2 | Active comparator | Not described Receives: Procedure: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
scarring in middle meatus 4 weeks after ESS
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tatu p Kemppainen, MD, Principal investigator, Kuopio University HospitalJuhani Nuutinen, PhD, Study director, Kuopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534768
- Sponsor's protocol ID
- KUH5551813
- Status last verified
- Jan 2008
- First submitted
- 24 Sep 2007
- Last updated
- 14 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Treatment After Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT00534768
- Acronym / sponsor ID
- KUH5551813
- Conditions
- Sinusitis
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Jan 2003
- First posted
- 26 Sep 2007 (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.
Objective: Even though postoperative debridement is commonly considered as an essential part of endoscopic sinus surgery (ESS), the scientific data on the efficacy or the optimal timing of debridement is limited. In the present study, the effect of repeated debridement during the first week after ESS on the endoscopic and subjective outcome was evaluated.
Study Design: Open, prospective, randomized, controlled clinical trial with two parallel groups.
Methods: A total of 90 patients suffering from either recurrent or chronic maxillary sinusitis were randomized into two groups after ESS. In the active group, the nasal cavities were debrided three times on the first postoperative week, while in the control group the patients were debrided only once on the 7th postoperative day. The primary outcome measure was the presence of scarring in the middle meatus at four weeks after ESS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: active debridementdebridement on 1st, 3-5th and 7th postoperative days |
| 2 | Active comparator | Procedure: control group |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A total of 90 patients (age 18-70 years), who underwent ESS in Kuopio University Hospital, Kuopio, Finland were included in this study.
- The patients suffered from either recurrent or chronic maxillary sinusitis and had American Society of Anaesthesiologists physical status 1 or 2.{{331 Sakland,M. 1941; }}
Key exclusion criteria (7 listed)
- Undergone previous sinus surgery or if they had severe nasal polyposis (radiological opacification more than 50 % of the sinuses (Lund-McKay classification)
- Hemorrhagic diathesis
- Liver or kidney dysfunction
- Chronic malnutrition
- Alcoholism or inflammatory bowel disease.
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 |
|---|---|---|
| active debridementdebridement on 1st, 3-5th and 7th postoperative days | Procedure or surgery | 1 |
| control groupPostoperative debridement on 7th postoperative day | Procedure or surgery | 2 |
Primary outcome
scarring in middle meatus 4 weeks after ESS
Time frame: 4 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 14 Jan 2008.
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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.
Tatu p Kemppainen, MD principal investigator
Kuopio University Hospital
Juhani Nuutinen, PhD study director
Kuopio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active debridement in people with Sinusitis, run by Kuopio University Hospital at 1 site in Finland.
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 2 inclusion and 7 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 14 Jan 2008. 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 Finland. 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?
scarring in middle meatus 4 weeks after ESS (time frame: 4 weeks). 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 14 Jan 2008.