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

Weight Gain Clinical Trial

— POEM  

Official title:

To Evaluate the Nutritional Parameters in Patients With Achalasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05161923
• Other study ID #: HREM1
• Status: Recruiting
• Start date: January 26, 2021
• Est. completion date: March 26, 2022

Study information

• Verified date: November 2021
• Source: Asian Institute of Gastroenterology, India
• Contact: Zaheer Dr Nabi, MBBS MD DNB
• Phone: 23378888
• Email: zaheernabi1978[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Esophageal Achalasia
• Nutritional Imbalance
• Weight Gain

Intervention

Procedure:
• Per oral endoscopy myotomy
The per-oral endoscopic myotomy, or POEM, is a minimally invasive surgical procedure for the treatment of achalasia wherein the inner circular muscle layer of the lower esophageal sphincter is divided through a submucosal tunnel.[1] This enables food and liquids to pass into the stomach, a process that is impaired in achalasia. The tunnel is created, and the myotomy performed, using a flexible endoscope, meaning the entire procedure can be done without external incisions.

Locations

Country	Name	City	State
India	Asian Institute of Gastroenterology	Hyderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

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