Clinical trial NCT05161923: COMPREHENSIVE ANALYSIS OF NUTRITIONAL PARAMETERS IN PATIENTS WITH IDIOPATHIC ACHALASIA: A PROSPECTIVE STUDY.
Official title: To Evaluate the Nutritional Parameters in Patients With Achalasia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Weight Gain
Nutritional Imbalance
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 patients

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: To assess the various nutritional indices in cases with treatment ( per oral endoscopic myotomy) failure cases with idiopathic achalasia
timeFrame: 12 months
Secondary outcomes:
measure: To evaluate the severity of malnutrition before and after undergoing Per-oral endoscopic myotomy (Per Oral Endoscopic Myotomy).
timeFrame: 12 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Asian Institute of Gastroenterology
state: Telangana
Study officials:
affiliation: Asian Institute of Gastroenterology
name: Mohan Dr Ramchandani, MBBS MD DNB
role: PRINCIPAL_INVESTIGATOR
References: