Disorder of Maxillary SinusCFTNCT01615536
The Role of Canine Fossa Trephination in the Severely Diseased Maxillary Sinus
A study testing Canine fossa trephine technique and Standard Endoscopic Sinus Surgery in people with Disorder of Maxillary Sinus and Aspirin-sensitive Asthma With Nasal Polyps, run by IWitterick at 1 site in Canada.
Trial summary
The hypothesis of this study is that canine fossa trephination (CFT) improves surgical outcomes for patients with a severely diseased maxillary sinus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Disorder of Maxillary Sinus, Aspirin-sensitive Asthma With Nasal Polyps, Rhinosinusitis
- What is being tested?
- Canine fossa trephine technique and Standard Endoscopic Sinus Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2010to Jan 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with extensively opacified maxillary sinuses on CT scanning undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis
- Patients with Eosinophilic Mucin Chronic Rhinosinusitis or fungal sinusitis disease undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis
- Patients with Recalcitrant Chronic Rhinosinusitis undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis
- Patients over the age of 18
- Patients able to give informed consent to participate in the study
Who cannot join
- Patients will be excluded if they are unable to undergo surgery due to co morbidities.
- Patients with previous Caldwell-Luc procedures
- Patients with pre existing paraesthesia of the upper teeth or gums
- Patients with destructive lesions of the maxilla
- Patients with systemic disease affecting the paranasal sinuses (e.g. Wegener's granulomatosis)
- Patients immune compromised
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis of this study is that canine fossa trephination (CFT) improves surgical outcomes for patients with a severely diseased maxillary sinus.
Read the detailed description
Chronic sinusitis (CRS) with nasal polyps and thick mucin in the sinuses adversely affects results from endoscopic sinus surgery (ESS) because failure to clear the disease leads to ongoing inflammation and symptoms. In particular a subset of CRS patients with thick eosinophilic mucin (EMCRS) develop recurrent symptoms and require further surgeries. ESS techniques for the maxillary sinus requires a WMA in the side wall of the sinus and the use of curved debrider instruments to clear the polyps. Sometimes this doesn't provide access to the inferior/floor and anterior/front aspects of the maxillary sinus due to the fact that the maxillary sinus is on the side of the nasal cavity at an angle. The CFT through the front wall of the sinus was developed years ago as an alternative approach to improve access to these areas. Both techniques are acceptable standard treatments and which one is initially used to address the maxillary sinus currently depends on surgeon preference. The role of CFT has been studied by Sathanatar et al (Laryngoscope 2005) and Lee et al (Laryngoscope 2008) which provided conflicting results. Differences in their study patients and methodology could explain the different outcomes. Hence this study is proposed to clarify the role of CFT in patients with extensive maxillary sinus disease to see whether initial use of CFT is more helpful than WMA in the severely diseased maxillary sinus with polyps and mucin. Findings from this study may improve surgical outcomes for CRS patients in the future.
- Being tested
- Canine fossa trephine technique, Standard Endoscopic Sinus Surgery
- Keywords
- chronic rhinosinusitis, canine fossa trephine, canine fossa puncture
- Medical subject headings
- Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canine fossa trephine techniqueProcedure or surgery
Also called Canine fossa puncture
Patients undergoing standard ESS and a canine fossa trephine technique, which is a 6 mm puncture in the anterior wall of the maxillary sinus, to allow standard sinus debrider blades and instruments to pass into the sinus to clear polyps in the maxillary sinus.
Standard Endoscopic Sinus SurgeryProcedure or surgery
Also called Functional Endoscopic Sinus Surgery
Patients undergoing standard ESS without canine fossa trephination with clearance of the maxillary sinus polyps via a wide maxillary antrostomy (WMA) with use of curved debrider surgical blades and instruments.
| Study group | Role | What they receive |
|---|---|---|
| Canine fossa trephine group (CFT) | Experimental | Not described Receives: Procedure: Canine fossa trephine technique |
| Non Canine fossa trephine group (NonCFT) | Active comparator | Not described Receives: Procedure: Standard Endoscopic Sinus Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard validated symptom scores
- Chronic sinusitis survey
- SNOT (Sinonasal Outcome Test)22
Measured: 6 months
Secondary outcomes (3)
Ability to completely clear the maxillary sinus of all disease (e.g. polyps and eosinophilic mucus)
Measured by using a surgeon survey
Measured: Measured during surgery
Surgical time spent clearing the maxillary sinus disease between the CFT and non-CFT groups
Measured in minutes
Measured: At the time of surgery
Endoscopy scores
- Grade 0: Normal mucosa with no evidence of disease
- Grade 1: Edematous mucosa and/or eosinophilic mucus
- Grade 2: Polypoidal mucosa and/or eosinophilic mucus
- Grade 3: Polyps and fungal debris
Measured: Measured at 2,6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionJan 2014
Why it stopped: Inability to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Disorder of Maxillary SinusStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWitterick
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, IWitterick, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Investigators
- Ian J Witterick, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615536
- Sponsor's protocol ID
- 09-0211-A
- Acronym
- CFT
- Status last verified
- Jan 2014
- First submitted
- 5 Jun 2012
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sathananthar S, Nagaonkar S, Paleri V, Le T, Robinson S, Wormald PJ. Canine fossa puncture and clearance of the maxillary sinus for the severely diseased maxillary sinus. Laryngoscope. 2005 Jun;115(6):1026-9. doi: 10.1097/01.MLG.0000162651.22019.4A.
PubMed 15933514Lee JY, Lee SH, Hong HS, Lee JD, Cho SH. Is the canine fossa puncture approach really necessary for the severely diseased maxillary sinus during endoscopic sinus surgery? Laryngoscope. 2008 Jun;118(6):1082-7. doi: 10.1097/MLG.0b013e318169028d.
PubMed 18388769Gliklich RE, Metson R. Techniques for outcomes research in chronic sinusitis. Laryngoscope. 1995 Apr;105(4 Pt 1):387-90. doi: 10.1288/00005537-199504000-00010.
PubMed 7715384Singhal D, Douglas R, Robinson S, Wormald PJ. The incidence of complications using new landmarks and a modified technique of canine fossa puncture. Am J Rhinol. 2007 May-Jun;21(3):316-9. doi: 10.2500/ajr.2007.21.3022.
PubMed 17621816Lund VJ, Mackay IS. Staging in rhinosinusitus. Rhinology. 1993 Dec;31(4):183-4. No abstract available.
PubMed 8140385
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Canine Fossa Trephination in the Severely Diseased Maxillary Sinus
- ClinicalTrials.gov ID
- NCT01615536
- Acronym / sponsor ID
- CFT / 09-0211-A
- Keywords
- chronic rhinosinusitis, canine fossa trephine, canine fossa puncture
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to recruit subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IWitterickUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 8 Jun 2012 (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 hypothesis of this study is that canine fossa trephination (CFT) improves surgical outcomes for patients with a severely diseased maxillary sinus.
Detailed description
Chronic sinusitis (CRS) with nasal polyps and thick mucin in the sinuses adversely affects results from endoscopic sinus surgery (ESS) because failure to clear the disease leads to ongoing inflammation and symptoms. In particular a subset of CRS patients with thick eosinophilic mucin (EMCRS) develop recurrent symptoms and require further surgeries. ESS techniques for the maxillary sinus requires a WMA in the side wall of the sinus and the use of curved debrider instruments to clear the polyps. Sometimes this doesn't provide access to the inferior/floor and anterior/front aspects of the maxillary sinus due to the fact that the maxillary sinus is on the side of the nasal cavity at an angle. The CFT through the front wall of the sinus was developed years ago as an alternative approach to improve access to these areas. Both techniques are acceptable standard treatments and which one is initially used to address the maxillary sinus currently depends on surgeon preference. The role of CFT has been studied by Sathanatar et al (Laryngoscope 2005) and Lee et al (Laryngoscope 2008) which provided conflicting results. Differences in their study patients and methodology could explain the different outcomes. Hence this study is proposed to clarify the role of CFT in patients with extensive maxillary sinus disease to see whether initial use of CFT is more helpful than WMA in the severely diseased maxillary sinus with polyps and mucin. Findings from this study may improve surgical outcomes for CRS patients in the future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canine fossa trephine group (CFT) | Experimental | Procedure: Canine fossa trephine technique |
| Non Canine fossa trephine group (NonCFT) | Active comparator | Procedure: Standard Endoscopic Sinus Surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with extensively opacified maxillary sinuses on CT scanning undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis
- Patients with Eosinophilic Mucin Chronic Rhinosinusitis or fungal sinusitis disease undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis
- Patients with Recalcitrant Chronic Rhinosinusitis undergoing Endoscopic Sinus Surgery for Chronic Rhinosinusitis
- Patients over the age of 18
- Patients able to give informed consent to participate in the study
Key exclusion criteria (6 listed)
- Patients will be excluded if they are unable to undergo surgery due to co morbidities.
- Patients with previous Caldwell-Luc procedures
- Patients with pre existing paraesthesia of the upper teeth or gums
- Patients with destructive lesions of the maxilla
- Patients with systemic disease affecting the paranasal sinuses (e.g. Wegener's granulomatosis)
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 |
|---|---|---|
| Canine fossa trephine techniqueAlso: Canine fossa puncturePatients undergoing standard ESS and a canine fossa trephine technique, which is a 6 mm puncture in the anterior wall of the maxillary sinus, to allow standard sinus debrider blades and instruments to pass into the sinus to clear polyps in the maxillary sinus. | Procedure or surgery | Canine fossa trephine group (CFT) |
| Standard Endoscopic Sinus SurgeryAlso: Functional Endoscopic Sinus SurgeryPatients undergoing standard ESS without canine fossa trephination with clearance of the maxillary sinus polyps via a wide maxillary antrostomy (WMA) with use of curved debrider surgical blades and instruments. | Procedure or surgery | Non Canine fossa trephine group (NonCFT) |
Primary outcome
Standard validated symptom scores
Time frame: 6 months
1. Chronic sinusitis survey 2. SNOT (Sinonasal Outcome Test)22
3 secondary outcomes
Ability to completely clear the maxillary sinus of all disease (e.g. polyps and eosinophilic mucus)
Time frame: Measured during surgery
Surgical time spent clearing the maxillary sinus disease between the CFT and non-CFT groups
Time frame: At the time of surgery
Endoscopy scores
Time frame: Measured at 2,6, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
- Background: PubMed 15933514Sathananthar S, Nagaonkar S, Paleri V, Le T, Robinson S, Wormald PJ. Canine fossa puncture and clearance of the maxillary sinus for the severely diseased maxillary sinus. Laryngoscope. 2005 Jun;115(6):1026-9. doi: 10.1097/01.MLG.0000162651.22019.4A.
- Background: PubMed 18388769Lee JY, Lee SH, Hong HS, Lee JD, Cho SH. Is the canine fossa puncture approach really necessary for the severely diseased maxillary sinus during endoscopic sinus surgery? Laryngoscope. 2008 Jun;118(6):1082-7. doi: 10.1097/MLG.0b013e318169028d.
- Background: PubMed 7715384Gliklich RE, Metson R. Techniques for outcomes research in chronic sinusitis. Laryngoscope. 1995 Apr;105(4 Pt 1):387-90. doi: 10.1288/00005537-199504000-00010.
- Background: PubMed 17621816Singhal D, Douglas R, Robinson S, Wormald PJ. The incidence of complications using new landmarks and a modified technique of canine fossa puncture. Am J Rhinol. 2007 May-Jun;21(3):316-9. doi: 10.2500/ajr.2007.21.3022.
- Background: PubMed 8140385Lund VJ, Mackay IS. Staging in rhinosinusitus. Rhinology. 1993 Dec;31(4):183-4. No abstract available.
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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.
Ian J Witterick, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canine fossa trephine technique and Standard Endoscopic Sinus Surgery in people with Disorder of Maxillary Sinus and Aspirin-sensitive Asthma With Nasal Polyps, run by IWitterick at 1 site in Canada.
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 5 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: withdrawn, as of the sponsor's last update on 10 Jan 2014. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Standard validated symptom scores (time frame: 6 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 NCT01615536, which also lists 5 linked publications.
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 10 Jan 2014.