Chronic Sinusitis Clinical Trial
— ESSOfficial title:
The Feasibility of Using MRI During Endoscopic Sinus Surgery
Before performing endoscopic sinus surgery (ESS-Endoscopic Sinus Surgery), every candidate
for surgery is referred to perform a sinus CT scan of the sinuses. Because of the complicated
anatomy of the sinuses and their proximity to vital organs such as the brain, eye, and
carotid artery, the surgeon use the CT imaging during surgery to adjust the anatomy and to
avoid complications such as blindness, brain damage and massive bleeding (0.3%). Sometimes
the CT is integrated into a navigation system, although there is no evidence that the use of
navigation systems reduces the rate of complications.
The aim of our study is to examine whether ESS can be performed in chronic sinusitis patients
using MRI, with CT being used as a backup only.
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | February 15, 2021 |
Est. primary completion date | February 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients with chronic sinusitis. 2. Patients designated for ESS surgery. Exclusion Criteria: 1. Patients who have already undergone ESS and/ or nasal septum/ turbinates surgery. 2. Patients with sinus cancer. 3. Patients after sinus injury. 4. Patients under 18 years of age. 5. Extreme Situations: The radiologist who analyzes the CT and MRI will warn of situations in which he or she will detect an increased risk of injury to vital organs. These situations will include: A. Dehiscence, as seen in CT, in the bony walls of: 1. The carotid artery. 2. Skull base. 3. Medial wall of the orbit. B. Situations in which an anatomical anomaly or distortion of the nasal or sinus cavity is observed in the CT imaging. C. Situations in which the radiologist identifies poor technical quality of the MRI, and, in particular, a poor demonstration of the bony components. |
Country | Name | City | State |
---|---|---|---|
Israel | Assuta Hospital 1st Floor Habarzel Street 20 Ramat Hahayal Tel Aviv | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Roee Landsberg | Assuta Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ease and saftey of use of MRI compared to CT during ESS | A questionnaire to assess the feasibility and ease of use of MRI during surgery will be filled out by the surgeon at the end of each surgery. What was your general feeling about this surgery using MRI as compared to a similar surgery in which you used CT? A SCALE OF 1-2-3 where 1- BETTER 2- SAME 3- WORSE Safety level using MRI compared to CT? A SCALE OF 1-2-3 where 1- BETTER 2- SAME 3- WORSE please rate the level of Ease of work in the different sinus groups (on a scale of 1-2-3 where 1- easy 2- somewhat easy 3- not easy) |
imediatly after surgery is done (+- 12 hours) | |
Primary | the impact of using MRI compared to CT during ESS Ease and saftey of use of MRI compared to CT during ESS | A questionnaire to assess the feasibility and ease of use of MRI during surgery will be filled out by the surgeon at the end of each surgery. How many times was there a sporadic Use of CT during surgery (1-3 times)? (yes / no) Was there a need for Continuous work with CT? (yes / no) were there any complications when working with MRI ( no / yes, if yes please elaborate) Do you think that an exposure to CT imaging would have changed the operation? If yes please elaborate |
imediatly after surgery is done (+- 12 hours) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02266810 -
Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus
|
Phase 3 | |
Completed |
NCT01706484 -
Efficacy and Safety of Two Dosages of a Herbal Medicinal Product (Dry Extract BNO 1016) in Chronic Rhinosinusitis
|
Phase 3 | |
Completed |
NCT01197612 -
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
|
Phase 3 | |
Completed |
NCT04163978 -
Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)
|
Phase 2 | |
Completed |
NCT04418622 -
Evolution of the Endonasal Microbiota in Patients With Chronic Rhinosinusitis
|
||
Not yet recruiting |
NCT06070311 -
Wound Healing After Endoscopic Sinus Surgery
|
N/A | |
Not yet recruiting |
NCT05454163 -
Post-radiotherapy Rhinosinusitis in Children
|
||
Withdrawn |
NCT01185808 -
Vitamin D Supplementation in Chronic Rhinosinusitis With Nasal Polyps
|
N/A | |
Completed |
NCT01700725 -
Gulf War Illness Nasal Irrigation Study
|
Phase 2 | |
Withdrawn |
NCT00671281 -
The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery
|
N/A | |
Completed |
NCT00447837 -
Evaluating SPRC-AB01 in Post-Surgical Subjects With Chronic Sinusitis
|
Phase 2 | |
Recruiting |
NCT04362501 -
Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
|
Phase 2 | |
Completed |
NCT05035654 -
LYR-220 for Adult Subjects With Chronic Rhinosinusitis (BEACON Study)
|
Phase 2 | |
Completed |
NCT02562924 -
The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery
|
N/A | |
Completed |
NCT01007799 -
Vitamin D for Chronic Sinusitis
|
N/A | |
Completed |
NCT03358329 -
Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE)
|
Phase 3 | |
Withdrawn |
NCT02981017 -
Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure
|
N/A | |
Completed |
NCT04041609 -
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
|
Phase 2 | |
Recruiting |
NCT01854619 -
Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis
|
N/A | |
Completed |
NCT00924404 -
Xylitol Versus Saline in Chronic Sinusitis
|
N/A |