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临床试验/NCT05161923
NCT05161923Unknown不适用

To Evaluate the Nutritional Parameters in Patients With Achalasia

Asian Institute of Gastroenterology, India1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年1月26日最近更新:
适应症

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

  1. .STUDY DESIGN: This study is a Prospective single arm observational study.
  2. .STUDY PERIOD: Jan 2021-May 2021. 3. SAMPLE SIZE: 100 participants.

INCLUSION CRITERIA:

  1. Male and female patients aged 18-60 years with confirmed diagnosis of idiopathic achalasia.
  2. 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

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

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohan Ramchandani

Clinical Professor

Asian Institute of Gastroenterology, India

研究点 (1)

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