The Feasibility of Using MRI During ESS

NCT03903432 | Unknown DMC

• 1 other identifier: 0059-18-ASMC
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Sinusitis

Keywords

MRI; CT; Chronic Sinusitis; ESS

Outcome Measures

Primary Outcomes (2)

• 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. 1. 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 2. Safety level using MRI compared to CT? A SCALE OF 1-2-3 where 1- BETTER 2- SAME 3- WORSE 3. 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)

• 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. 1. How many times was there a sporadic Use of CT during surgery (1-3 times)? (yes / no) 2. Was there a need for Continuous work with CT? (yes / no) 3. were there any complications when working with MRI ( no / yes, if yes please elaborate) 4. 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)

Study Arms (1)

45 participants, in one center - Assuta

OTHER

Patients with chronic sinusitis who are scheduled to undergo ESS at Assuta will be recruited and patients will sign an informed consent form for performing MRI (new protocol-without gadolinium injection) in addition to the routine CT.

Other: MRI

Interventions

MRI OTHER

candidates for ESS will be referred to conventional CT scans of the sinuses. If surgery is to be performed, the patients will sign an informed consent and be referred for a sinus MRI.

Also known as: CT

45 participants, in one center - Assuta

Eligibility Criteria

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

You may qualify if:

• Patients with chronic sinusitis.
• Patients designated for ESS surgery.

You may not qualify if:

• Patients who have already undergone ESS and/ or nasal septum/ turbinates surgery.
• Patients with sinus cancer.
• Patients after sinus injury.
• Patients under 18 years of age.
• 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:
• The carotid artery.
• Skull base.
• 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.

Sponsors & Collaborators

• Roee Landsberg: lead
• Assuta Medical Center: collaborator

Study Sites (1)

Assuta Hospital 1st Floor Habarzel Street 20 Ramat Hahayal Tel Aviv

Tel Aviv, 972, Israel

Location

Study Officials

• Roee Landsberg, M.D

  Assuta Hospital 1st Floor Habarzel Street 20 Ramat Hahayal Tel Aviv

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roee Landsberg, M.D

CONTACT

+972524266359; roeela@assuta.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: April 4, 2019
• Study Start: May 15, 2019
• Primary Completion: February 15, 2020
• Study Completion: February 15, 2021
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

IL (1)