Weight Gain Clinical Trial
— POEMOfficial title:
To Evaluate the Nutritional Parameters in Patients With Achalasia
NCT number | NCT05161923 |
Other study ID # | HREM1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 26, 2021 |
Est. completion date | March 26, 2022 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | March 26, 2022 |
Est. primary completion date | December 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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: 1. Chronic diarrhea, malignancy, severe comorbid illness affecting the nutritional status 2. Previously treated and asymptomatic cases with achalasia |
Country | Name | City | State |
---|---|---|---|
India | Asian Institute of Gastroenterology | Hyderabad | Telangana |
Lead Sponsor | Collaborator |
---|---|
Asian Institute of Gastroenterology, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the various nutritional indices in cases with treatment ( per oral endoscopic myotomy) failure cases with idiopathic achalasia | 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. | 12 months | |
Secondary | To evaluate the severity of malnutrition before and after undergoing Per-oral endoscopic myotomy (Per Oral Endoscopic Myotomy). | To determine the anthropometric assessment i.e., amount of weight loss or weight gain and its duration, change in triceps skinfold and midupperarm circumference of patients diagnosed with idiopathic achalasia. | 12 months |
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