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

To Evaluate the Nutritional Parameters in Patients With Achalasia

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.

Study Overview

• Status: Recruiting
• Conditions: Weight Gain; Nutritional Imbalance
• Intervention / Treatment: Procedure: Per oral endoscopy myotomy

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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Zaheer Dr Nabi, MBBS MD DNB; Phone Number: 040 23378888; Email: zaheernabi1978@gmail.com
• Study Contact Backup: Name: Rajesh Mr Goud, M.Pharma, MBA; Phone Number: 040 23378888; Email: rajeshgoud761@gmail.com

Study Locations

• India
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Recruiting
      • Asian Institute of Gastroenterology
      • Contact: Rajesh Mr Goud, M.Pharma MBA; Phone Number: 040 23378888; Email: rajeshgoud761@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

100 patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.; Other Names: POEM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: Mohan Dr Ramchandani, MBBS MD DNB, Asian Institute of Gastroenterology

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2021
• Primary Completion (Anticipated): December 25, 2021
• Study Completion (Anticipated): March 26, 2022

Study Registration Dates

• First Submitted: December 4, 2021
• First Submitted That Met QC Criteria: December 4, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Body Weight; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Body Weight Changes; Weight Gain; Esophageal Achalasia
• Other Study ID Numbers: HREM1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No