The Impact of Small Bowel Obstruction (SBO) on Quality of Life (QOL); the Efficacy of a Manual Physical Therapy to Improve QOL in Subjects With a History of SBO
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Quality of life
研究概览
简要总结
This study has two segments the first is a chart and outcome assessment of patients treated at Clear Passage (CP) with a history of small bowel obstruction (SBO). These patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. The second segment is a prospective observational, online questionnaire based study of subjects with a history of SBO not treated at CP. Data on the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed using the same questionnaire used as standard of care in the clinic twice, 90 days apart. This will be accomplished using the NIH Assessment Center, with subjects able to complete the questionnaires with ease via the internet. As this segment is observational, there is minimal risk to these subjects. The data obtained from the untreated subjects will allow for reporting of overall impact on QOL in this population, data that is not available, as well as provide a control group for assessment of improvement for interventions for SBO.
详细描述
This study has two segments the first is a chart and outcome assessment of patients treated at Clear Passage (CP) with a history of small bowel obstruction (SBO). These patients have completed multiple questionnaires as a standard of care for outcome monitoring in the clinic setting, no new data will be collected. The second segment is a prospective observational, online questionnaire based study of subjects with a history of SBO not treated at CP. Data on the impact of quality of life (QOL) over time of subjects not treated at CP will be assessed using the same questionnaire used as standard of care in the clinic twice, 90 days apart. This will be accomplished using the NIH Assessment Center, with subjects able to complete the questionnaires with ease via the Assessment Center. As this segment is observational, there is minimal risk to these subjects. The data obtained from the untreated subjects will allow for reporting of overall impact on QOL in this population, data that is not available, as well as provide a control group for assessment of improvement for interventions for SBO.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 90 years old
- •Previous diagnosis of partial or total bowel obstruction in the last 2 years.
- •Able to complete the questionnaire online via Assessment Center.
排除标准
- •Currently pregnant
- •Cancer within the last 10 years
- •Chemotherapy or radiation treatments within the last 10 years
- •Prior treatment at Clear Passage
结局指标
主要结局
Quality of life
时间窗: 90 days
Questionnaire based study for QOL changes over 90 days
次要结局
未报告次要终点
研究者
Lawrence Wurn
CEO
Clear Passage Therapies, Inc
