Outcome of post pancreatic enzyme replacement therapy in patients of pancreatic exocrine insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Assess reduction in pain, bloating and sticky stool and weight changes post pancreatic enzyme replacement therapy in patients of pancreatic exocrine insufficiency
研究概览
简要总结
An observational study for patients suffering from pancreatic exocrine insufficiency undergoiong pancreatic enzyme replacement therapy. Well informed consent will be obtained for inclusion in study and publication of study ,Relevant details will be collected related to clinical symptoms signs duration onset other co morbidities history of diet alcohol consumption and smoking multiple parameters including pain assessed by visual analogue scale,
Grading of CT scan findings based on Baltahazar CT severity index
Documentation of weight changes pre and post therapy using same standard weighing scale .
General improvement in clinical symptoms and lifestyle changes will be assessed through WHO quality of life scale
Regular follow up at 0 days – 15 days – 45 days to check compliance towards therapy will be done first hand using Morisky Medication Adherence Scale (MMAS-8)
A standard proforma will be used to record patient data and informed consent will be obtained from the patients before enrolment to the study for inclusion and publication.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically confirmed case of acute and chronic pancreatitis with exocrine insufficiency in patients above 18 years of age Patients with Baltahazar CT severity index of 2 and more.
排除标准
- •Other pancreatic pathology like pancreatic malignancy, cyst.
- •Contraindicated cases for contrast ct study.
- •Patients where quality of life cannot be assessed.
结局指标
主要结局
Assess reduction in pain, bloating and sticky stool and weight changes post pancreatic enzyme replacement therapy in patients of pancreatic exocrine insufficiency
时间窗: 0 days 15 days 45 days
次要结局
- Grading of complaints of pain on the basis of ‘visual analogue scale’(Grading of CT scan findings based on Baltahazar CT severity index)
研究者
Dr SOMYA GOEL
Jawaharlal Nehru Medical College Sawangi(Meghe), Wardha