Chronic Abdominal Pain After Gastric Bypass for Morbid Obesity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Chronic abdominal pain 2 years post gastric bypass surgery
研究概览
简要总结
The study aims to explore patients perception of chronic abdominal pain after Roux en Y gastric bypass surgery for morbid obesity. The investigators aim to describe characteristics of symptoms of pain. Potential risk factors for developing abdominal pain post gastric bypass will be explored.
详细描述
This is a single-center, prospective, longitudinal, cohort study performed at the Department of Morbid Obesity and Bariatric Surgery, Oslo University Hospital. Patients undergoing gastric bypass are eligible for inclusion. The study is approved by the Regional Committee for Medical and Health Research Ethics (no.2013/1263), South-East health region. All participants provide written consent for study paennrollment.
The participants are asked to fill inn a set of questionnaires before and during follow-up after gastric bypass surgery. Symptom characteristics are explored and evaluated. Quality of life is included in the analyses. The main outcome is findings at 2 years post surgery, but the patients will be followed for 5 years.
The investigators also aim to evaluate by objective measures the patients perception of pain by temperature and skin pressure stimulants before and after surgery (2 years).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Indication for gastric bypass surgery i.e. BMI > 40 kg/m2 or BMI > 35 kg/m2 and obesity related comorbidity following failed attempts of sustained weight loss
排除标准
- •Other indications for gastric bypass surgery than obesity
- •Previous bariatric surgery
- •Other concomitant surgical procedures for abdominal pain such as cholecystectomy
结局指标
主要结局
Chronic abdominal pain 2 years post gastric bypass surgery
时间窗: Patient follow up complete 2020
questionnaire
次要结局
- Quality of life(patient follow up complete 2020)
- Objective evaluation of pain perception(baseline and 2 years)
研究者
Tom Mala
consultant, phd
Oslo University Hospital