Impact of Postoperative Regular Diet on Colorectal Outcomes and Patient Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of 30-day readmissions
研究概览
简要总结
The goal of this pilot study is to assess the safety and feasibility of regular diet after surgical removal of the colon. The study will enroll patients preoperatively, prior to colon surgery, and will follow participants for up to 30 days. The study hypothesizes that simplifying nutritional recommendations is safe and may improve quality of life.
详细描述
This pilot study aims to establish the safety of a return to a regular diet after surgery. Patients scheduled to undergo removal of a piece of their colon will be recruited before surgery and placed on a regular diet after surgery. Participants in this trial will be compared with previous patients who have undergone a similar surgery but were educated on and prescribed a low-fiber diet after surgery. Measures relating to morbidity and 30-day readmission rate will be collected prospectively. Surgical complications will also be collected. Participants will complete surveys about anxiety and quality of life at various time points in the study.
The study will track the healthcare resources needed by participants during this study through a number of metrics, such as visits, phone calls, and messaging.
The overarching goals of this study are to determine if resuming a regular diet after surgery is safe, if it impacts quality of life, and whether it increases how often patients need to engage with the healthcare system. The study will also explore associations with patient anxiety and strain on the care team in the form of communications related to diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Male or female ≥ 18 years of age
- •Scheduled to undergo colorectal resection
排除标准
- •Patients with bowel obstructions
- •Patients below the age of 18
研究组 & 干预措施
Regular Diet
干预措施: Regular Diet Post-Operatively (Other)
Historical Control
This comparator arm consists of information about the safety of patients treated in the past,
干预措施: Historical Cohort: Low-Fiber Diet (Other)
结局指标
主要结局
Number of 30-day readmissions
时间窗: 30 Days post-operative
Surgery related morbidity
时间窗: 30 Days Post-Operatively
次要结局
- Percent of participants who complete the study (Feasibility)(30 Days Post-Operatively)
- Number of participants who drop out of the study(30 Days Post-Operatively)
- Number of participants removed from the study due to clinical determination(30 Days Post-Operatively)