Quality of Life of Crohn's Disease Patients With Complex Perianal Fistulas: an Observational, Cross-sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 5
- 主要终点
- Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12]
研究概览
简要总结
The main aim of the study is to assess the quality of life of people with Crohn's disease after treatment for complex perianal fistulas (CPF) in a standard clinic setting.
Study doctors will review the participants' medical records in the last 3 years. Participants will also be asked to visit the clinic once to complete 1 questionnaire on their quality of life.
详细描述
This is a national, observational, cross-sectional study. The study will assess the general QoL among CD participants with CPFs in the Portuguese routine clinical practice.
This study will enroll approximately 80 participants. All participants will be enrolled in one observational cohort.
The data will be collected retrospectively, from the medical records, on healthcare resource utilization and on the pharmacological and surgical treatments used for the management of CPFs in the three years prior to the inclusion visit.
This multi-center trial will be conducted in Portugal. The overall duration of this study is approximately 8 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Diagnosed with CD.
- •Presence of CPF(s), defined as >=1 of the following criteria:
- •High intersphincteric, high transsphincteric, extrasphincteric, or suprasphincteric location;
- •>=2 external openings;
- •Associated collections.
- •Attending routine gastroenterology appointments at the participating hospitals.
排除标准
- •Diagnosed with ulcerative colitis or indeterminate inflammatory bowel disease (IBD).
- •With non-complex fistulas or with fistulas types other than perianal (example, rectovaginal).
结局指标
主要结局
Meta-Scores of the 12-Item Short Form Health Survey (SF-12) Questionnaire's Physical Component Score [PCS-12]
时间窗: At inclusion visit (Day 1)
SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the physical component summary (PCS) and the mental component summary (MCS), of which the PCS component is presented in this outcome measure. The PCS score has a range of 0 to 100. Higher scores indicate better physical functioning.
Meta-Scores of the SF-12 Questionnaire's Mental Component Score [MCS-12])
时间窗: At inclusion visit (Day 1)
SF-12 is 12-item self-report that assesses physical and mental health related general quality of life (QoL) whose results are expressed in terms of two meta-scores: the PCS and the MCS, of which the MCS component is presented in this outcome measure. The MCS score has a range of 0 to 100. Higher scores indicate better mental functioning.
次要结局
- Number of Participants Characterized Based on Pharmacological Treatments and Surgeries for CPF(Up to 3 years prior to the inclusion visit at Day 1)
- Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables(At inclusion visit (Day 1))
- Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as Correlation Coefficient Stratified Based on Quantitative Variables(At inclusion visit (Day 1))
- Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score(At inclusion visit (Day 1))
- Sexual Quality of Life-Female (SQOL-F) Questionnaire Score for Female Participants(At inclusion visit (Day 1))
- Fecal Incontinence as Assessed by Wexner Score(At inclusion visit (Day 1))
- Number of Participants Categorized Based on Sociodemographic and Anthropometric Characteristics(At inclusion visit (Day 1))
- Sexual Quality of Life-Male (SQOL-M) Questionnaire Score for Male Participants(At inclusion visit (Day 1))
- Number of Participants With Moderate to Severe Crohn's Disease (CD) Stratified by Clinical Characteristics(At inclusion visit (Day 1))
- Correlation Between General QoL MCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as MCS Score Stratified Based on Qualitative Variables(At inclusion visit (Day 1))
- Work Productivity and Activity Impairment (WPAI) as Assessed by WPAI Questionnaire Score(At inclusion visit (Day 1))
- Number of Participants Characterized Based on Healthcare Resource Utilization (HCRU) Within Previous 3 Years(Up to 3 years prior to the inclusion visit at Day 1)
- Correlation Between General QoL PCS-12 and the Participants Socio-demographic, Anthropometric and Clinical Characteristics Assessed as PCS Score Stratified Based on Qualitative Variables(At inclusion visit (Day 1))