The Impact of 3D Anal Fistula Models on Patient Understanding and Decision Making
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Patient understanding of fistula anatomy and surgery
研究概览
简要总结
An anal fistula is an abnormal communication between the luminal surface of the anorectal canal and the perianal skin. Fistulas can vary in their complexity and can be challenging to treat, due to the anatomical relation to the anal sphincter complex that controls continence. In addition, fistulas can display complex features such as branches, cavities and horseshoes; where the tract travels radially around the anal canal. All these features have a role in determining the most appropriate surgical treatment option, and are key to understanding the surgical decision-making process. This study will determine patient understanding of fistula anatomy, their perception of their own understanding, their rating of how good their clinician's explanation is and how this impacts the decision-making process using standard explanation with 2D images, versus a 3D printed model of a fistula.
详细描述
Previous work has established a method of using traditional two-dimensional MR images to construct and print 3D models of perianal fistula, however the clinical utility of these models in the outpatient setting and their impact on patient knowledge of disease have not yet been assessed. This study is aimed at understanding how the use of 3D printed models can influence patient understanding of disease and support them in making decisions regarding treatment.
Participants attending routine outpatient appointments will have their fistula explained to them using either a standard explanation, or a 3D printed model of a fistula. They will complete a short series of questionnaires and their answers will be analysed to determine if there is any benefit of using 3D models in a clinical consultation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients
- •Aged ≥18 years old
- •Patients who are new referrals to complex fistula clinic
- •Patients with an idiopathic or Crohn's perianal fistula
- •Patients with an intersphincteric or transsphincteric fistula according to Park's classification
- •Patients who have had MR imaging of their anal fistula prior to consultation
- •Able to give full informed consent
排除标准
- •Patients < 18 years
- •Patients with a rectovaginal or pouch fistula
- •Fistula secondary to malignancy or radiation
- •Suprasphincteric or extrasphincteric fistulas
- •Follow up patients
- •Patients who have no prior MR imaging of their fistula Patients who do not have the capacity to consent
结局指标
主要结局
Patient understanding of fistula anatomy and surgery
时间窗: 5 minutes
A score obtained using a non-validated questionnaire that assesses the patient's understanding of their fistula anatomy and the treatment that has been proposed. Scores can range from 0 to 16, with a higher score suggesting better understanding.
次要结局
- Patient understanding of their fistula: Patient reported subjective assessment(1 minute)
- Decisional Conflict Scale(5 minutes)
- Quality of explanation: Patient reported subjective assessment(1 minute)
- 3D model utility(1 minute)