Clinical Trial: Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective Study for Improvement in Outcomes Following Draf III/Endoscopic Modified Lothrop Procedure Using a Porcine Intestinal Submucosal Graft

Brief Summary: We propose a randomized, single-blinded, prospective trial in order to evaluate the efficacy of the Cook Biodesign ENT Repair graft in improving outcomes after the Draf III or Endoscopic Modified Lothrop procedure. The Cook Biodesign ENT Repair graft is a porcine intestinal submucosal xenograft which has been FDA approved for use as an adjunct to natural healing process in the sinonasal cavity. The Draf III or Endoscopic Modified Lothrop involved creating a large unified drainage pathway for refractory frontal sinusitis. After the procedure is completed, there is exposed bone along the frontal beak region which can become a nidus for inflammation, crusting and eventual scarring, leading to stenosis or even complete blockage of the frontal sinuses. The Cook Biodesign will be used to cover this exposed bone in order to potentially reduce the inflammation, crusting and scarring and possibly improve outcomes.

Detailed Summary:

Chronic rhinosinusitis (CRS) is an inflammatory disorder affecting the sinonasal mucosa. Chronic symptoms include facial pain and pressure, nasal airway obstruction, anosmia and nasal discharge (sometimes purulent), in addition to significant effects on overall quality of life. The cost of CRS is estimated to be approximately $4 billion per year and results in over 20 million physician visits per year. The frontal sinuses are paired paranasal sinuses housed superiorly and anteriorly in the frontal bone on each side, separated by an inter-sinus septum which is contiguous with the nasal septum. The frontal sinuses, like the other paranasal sinuses, can be affected in chronic rhinosinusitis, with inflammation of the frontal sinus outflow tract causing obstruction and subsequent symptoms. First line therapy involves medical therapy often with combination of antibiotics, nasal saline irrigation, topical and/or systemic corticosteroids, with endoscopic sinus surgical therapy reserved for patients with persistent symptoms after medical therapy.

Surgical therapy of the frontal sinus is the most technically demanding aspect of endoscopic sinus surgery, and due to this, surgical dissection of the frontal sinuses has been discouraged in the past. Otolaryngology textbooks also emphasize that chronic frontal sinus disease may be related to unnecessary instrumentation of the frontal recess. With recent advances in endoscopic sinus surgery and the advent of balloon sinusotomy, the rate of frontal sinus surgery has more than doubled from 2000 to 2009.

Primary frontal sinus surgery can be approached with balloon dilation or by endoscopic sinusotomy. Endoscopic sinusotomy of the frontal sinus involves increasing the size of the frontal recess with anterior ethmoidectomy and removal of the agger nasi cell anteriorly, and any frontal cells th
Sponsor: University of California, Los Angeles

Current Primary Outcome: Frontal sinus stenosis [ Time Frame: 1 year ]

Evaluate the size of the frontal sinus outflow tract over one year after surgery


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of postoperative debridements [ Time Frame: 1 year ]
    Track the number of debridements required in the postoperative period
  • Need for further surgical intervention [ Time Frame: 1 year ]
    Track if any further surgical procedures (in office or in operating room) that are required during postoperative period
  • Number of postoperative infections [ Time Frame: 1 year ]
    Track the number of postoperative sinus infections, proven by culture, as well as the number of antibiotic courses required for treatment.
  • Lund Kennedy Endoscopy Score [ Time Frame: 1 year ]
    Evaluation of the sinuses using nasal endoscopy and objective measurement using the validated Lund-Kennedy Endoscopy score
  • SNOT-22 score [ Time Frame: 1 year ]
    Evaluation of patient quality of life using a validated questionnaire called the Sinonasal Outcome Test (SNOT) - 22.


Original Secondary Outcome: Same as current

Information By: University of California, Los Angeles

Dates:
Date Received: November 30, 2016
Date Started: November 2016
Date Completion: December 2018
Last Updated: November 30, 2016
Last Verified: November 2016