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COMPREHENSIVE ANALYSIS OF NUTRITIONAL PARAMETERS IN PATIENTS WITH IDIOPATHIC ACHALASIA: A PROSPECTIVE STUDY. — POEM  

Weight Gain Clinical Trial

Official title:
To Evaluate the Nutritional Parameters in Patients With Achalasia

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05161923
Study type Observational
Source Asian Institute of Gastroenterology, India
Contact Zaheer Dr Nabi, MBBS MD DNB
Phone 23378888
Email zaheernabi1978@gmail.com
Status Recruiting
Phase
Start date January 26, 2021
Completion date March 26, 2022
View Details
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