The Role of Canine Fossa Trephination in the Severely Diseased Maxillary Sinus

NCT01615536 | Withdrawn

• 1 other identifier: 09-0211-A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of this study is that canine fossa trephination (CFT) improves surgical outcomes for patients with a severely diseased maxillary sinus.

Conditions

Disorder of Maxillary Sinus; Aspirin-sensitive Asthma With Nasal Polyps; Rhinosinusitis

Keywords

chronic rhinosinusitis; canine fossa trephine; canine fossa puncture

Outcome Measures

Primary Outcomes (1)

• Standard validated symptom scores

  1. Chronic sinusitis survey 2. SNOT (Sinonasal Outcome Test)22

  6 months

Secondary Outcomes (3)

• Ability to completely clear the maxillary sinus of all disease (e.g. polyps and eosinophilic mucus)

  Measured during surgery

• Surgical time spent clearing the maxillary sinus disease between the CFT and non-CFT groups

  At the time of surgery

• Endoscopy scores

  Measured at 2,6, 12 months

Study Arms (2)

Canine fossa trephine group (CFT)

EXPERIMENTAL

Procedure: Canine fossa trephine technique

Non Canine fossa trephine group (NonCFT)

ACTIVE COMPARATOR

Procedure: Standard Endoscopic Sinus Surgery

Interventions

Canine fossa trephine technique PROCEDURE

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.

Also known as: Canine fossa puncture

Canine fossa trephine group (CFT)

Standard Endoscopic Sinus Surgery PROCEDURE

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.

Also known as: Functional Endoscopic Sinus Surgery

Non Canine fossa trephine group (NonCFT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IWitterick: lead

Study Sites (1)

Mt Sinai Hospital

Toronto, Ontario, M5G 1H4, Canada

Location

Related Publications (5)

• 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.

  PMID: 15933514 BACKGROUND

• Lee 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.

  PMID: 18388769 BACKGROUND

• Gliklich 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.

  PMID: 7715384 BACKGROUND

• Singhal 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.

  PMID: 17621816 BACKGROUND

• Lund VJ, Mackay IS. Staging in rhinosinusitus. Rhinology. 1993 Dec;31(4):183-4. No abstract available.

  PMID: 8140385 BACKGROUND

MeSH Terms

Conditions

Rhinosinusitis

Condition Hierarchy (Ancestors)

Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Ian J Witterick, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Otolaryngologist Head-Neck Surgeon

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 8, 2012
• Study Start: December 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

CA (1)