To Evaluate the Nutritional Parameters in Patients With Achalasia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess the various nutritional indices in cases with treatment ( per oral endoscopic myotomy) failure cases with idiopathic achalasia
研究概览
简要总结
A total of 100 patients aged 18-60 years with confirmed diagnosis of achalasia cardia will be recruited prospectively. In this study, patients diagnosed with achalasia cardia (prior to per oral endoscopic myotomy treatment) will undergo comprehensive evaluation of their nutritional status. All the participants will be asked about the details enlisted in pre-tested proforma.The evaluation will include demographic data(age, gender, food preferences, socio economic status,underlying diseases such as hypertension diabetes mellitus etc) anthropometric assessment (height, weight, Body Mass Index, weight loss and duration, percentage weight loss, midupperarm circumference , triceps skin fold, hand grip strength) and biochemical assessment (Hemoglobin, serum albumin and serum pre-albumin,total protein, serum Vitamin D, calcium, B12, serum iron). Each patients' dietary habits will be assessed by SUBJECTIVE GLOBAL ASSESMENT questionnaire (weight change, dietary intake, gastrointestinal symptoms, functional capacity, oedema, subcutaneous fat,muscle wasting, ascites.The obtained data will be statistically analyzed and interpreted. As we are in the midst of COVID-19 pandemic, we will be taking utmost safety precautions to prevent cross-infection. The doctor performing the study and the accompanying technician will be donning the personal protection equipment all throughout the study.
详细描述
- .STUDY DESIGN: This study is a Prospective single arm observational study.
- .STUDY PERIOD: Jan 2021-May 2021. 3. SAMPLE SIZE: 100 participants.
INCLUSION CRITERIA:
- Male and female patients aged 18-60 years with confirmed diagnosis of idiopathic achalasia.
- Patients who are co-operative, can communicate verbally and willing to give informed consent.
EXCLUSION CRITERIA: 3. Chronic diarrhea, malignancy, severe comorbid illness affecting the nutritional status 4. Previously treated and asymptomatic cases with achalasia
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Male and female patients aged 18-60 years with confirmed diagnosis of idiopathic achalasia.
- •Patients who are co-operative, can communicate verbally and willing to give informed consent.
排除标准
- •Chronic diarrhea, malignancy, severe comorbid illness affecting the nutritional status
- •Previously treated and asymptomatic cases with achalasia
结局指标
主要结局
To assess the various nutritional indices in cases with treatment ( per oral endoscopic myotomy) failure cases with idiopathic achalasia
时间窗: 12 months
To assess the detailed biochemical assessment i.e., change in the levels of hemoglobin, serum albumin, total protein, vitamin D, calcium, vitamin B12 before and after the per oral endoscopic myotomy procedure.
次要结局
- To evaluate the severity of malnutrition before and after undergoing Per-oral endoscopic myotomy (Per Oral Endoscopic Myotomy).(12 months)
研究者
Mohan Ramchandani
Clinical Professor
Asian Institute of Gastroenterology, India
