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

NCT05161923 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-12-29

No results posted yet for this study

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.

Conditions

  • Weight Gain
  • Nutritional Imbalance

Interventions

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.

Sponsors & Collaborators

  • Asian Institute of Gastroenterology, India

    lead OTHER

Principal Investigators

  • Mohan Dr Ramchandani, MBBS MD DNB · Asian Institute of Gastroenterology

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-26
Primary Completion
2021-12-25
Completion
2022-03-26

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05161923 on ClinicalTrials.gov