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

NCT ID: NCT05161923

Last Updated: 2021-12-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-26
• Study Completion Date: 2022-03-26

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

Conditions

Weight Gain; Nutritional Imbalance

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Per oral endoscopy myotomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

POEM

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asian Institute of Gastroenterology, India

OTHER

Sponsor Role: lead

Responsible Party

Mohan Ramchandani

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohan Dr Ramchandani, MBBS MD DNB

Role: PRINCIPAL_INVESTIGATOR

Asian Institute of Gastroenterology

Locations

Asian Institute of Gastroenterology

Hyderabad, Telangana, India

Site Status: RECRUITING

Countries

India

Central Contacts

Zaheer Dr Nabi, MBBS MD DNB

Role: CONTACT

zaheernabi1978@gmail.com

23378888 ext. 040

Rajesh Mr Goud, M.Pharma, MBA

Role: CONTACT

rajeshgoud761@gmail.com

23378888 ext. 040

Facility Contacts

Rajesh Mr Goud, M.Pharma MBA

Role: primary

rajeshgoud761@gmail.com

23378888 ext. 040

References

Nabi Z, Basha J, Inavolu P, Goud R, Veligatla V, Tummuru SP, Cheripelli N, Arutla M, Ramchandani M, Darisetty S, Nageshwar Reddy D. Comprehensive analysis of nutritional parameters in patients with idiopathic achalasia: A prospective study in India. Indian J Gastroenterol. 2025 Feb;44(1):57-63. doi: 10.1007/s12664-024-01664-5. Epub 2024 Aug 19.

Reference Type: DERIVED

PMID: 39158832 (View on PubMed)

Other Identifiers

HREM1

Identifier Type: -

Identifier Source: org_study_id