NCT01860053暂停2 期
A Behavioral Intervention to Decrease Vomiting and Improve Weight Loss in Post-Operative Laparoscopic Adjustable Gastric Banding (LAGB) Patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- change in frequency of self-reported vomiting (number of vomiting episodes each week) measured via structured interview
研究概览
简要总结
The purpose of this study is to reduce problematic vomiting and associated gastrointestinal symptoms in post-operative LAGB patients. We hypothesize that our behavioral intervention will yield greater reductions in vomiting and associated symptoms compared to our control condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years.
- •Received LAGB surgery with either a standard Lap-Band or a standard Realize Band.
- •Report vomiting at least 3x/week.
- •Agree to allow researchers to communicate with their surgeon regarding their care.
- •Fulfilled all hospital surgery criteria.
排除标准
- •Report a condition that in the judgment of the Principal Investigator would render them potentially unlikely to follow the protocol (e.g., major illness, plans to move out of the area, substance abuse or other significant psychiatric problems, organic brain disease).
- •Report planning to become pregnant during the time frame of the investigation.
- •Report a history of upper gastrointestinal dismotility.
结局指标
主要结局
change in frequency of self-reported vomiting (number of vomiting episodes each week) measured via structured interview
时间窗: baseline to week 6
次要结局
- change in gastrointestinal symptom severity - questionnaire measures severity of various GI symptoms over the previous week and items are summed yielding an overall GI severity index(baseline to week 6)
研究者
Tricia M. Leahey, Ph.D.
Assistant Professor (Research)
The Miriam Hospital
研究点 (2)
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