The Feasibility of Using MRI During Endoscopic Sinus Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Ease and saftey of use of MRI compared to CT during ESS
研究概览
简要总结
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.
详细描述
The sinuses are different from person to person and from side to side, and therefore it is essential to be completely familiar with the anatomy of the specific patient.
The sinuses are a maze of cells filled with air and surrounded by thin bony partitions separating the cells, as well as separating the nasal and sinus cavities from the vital organs mentioned.
CT imaging is the standard test because it allows accurate detection of the bony partitions, thus contributing to the accuracy and safety of the operation.
The known disadvantage of the CT is its radiation. The amount of radiation is not negligible and involves the possible development of eye damage (cataracts) or tumors.
For a large number of patients, the CT imaging performed before surgery is neither the first nor the last, so that the risk of tumor disease increases significantly, especially for the younger population. Another disadvantage is the limited ability of the imaging to demonstrate soft tissue.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic sinusitis.
- •Patients designated for ESS surgery.
排除标准
- •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.
研究组 & 干预措施
45 participants, in one center - Assuta
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.
干预措施: MRI (Other)
结局指标
主要结局
Ease and saftey of use of MRI compared to CT during ESS
时间窗: imediatly after surgery is done (+- 12 hours)
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)
the impact of using MRI compared to CT during ESS Ease and saftey of use of MRI compared to CT during ESS
时间窗: imediatly after surgery is done (+- 12 hours)
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
次要结局
未报告次要终点
研究者
Roee Landsberg
Principal Investigator
Assuta Medical Center