Weight GainPOEMNCT05161923
COMPREHENSIVE ANALYSIS OF NUTRITIONAL PARAMETERS IN PATIENTS WITH IDIOPATHIC ACHALASIA: A PROSPECTIVE STUDY.
An observational study of Weight Gain and Nutritional Imbalance, run by Asian Institute of Gastroenterology, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Weight Gain, Nutritional Imbalance
- What is being tested?
- Per oral endoscopy myotomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 26 Jan 2021to 26 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: 100 patients
Who may be able to join
- Male and female patients aged 18-60 years with confirmed diagnosis of idiopathic achalasia.
- Patients who are co-operative, can communicate verbally and willing to give informed consent.
Who cannot join
- Chronic diarrhea, malignancy, severe comorbid illness affecting the nutritional status
- Previously treated and asymptomatic cases with achalasia
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology
Hyderabad, Telangana, 500082
Rajesh Mr Goud, M.Pharma MBA, 23378888 ext. 040, rajeshgoud761@gmail.com
About this study
Official title: 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.
Read the detailed description
- .STUDY DESIGN: This study is a Prospective single arm observational study.
- .STUDY PERIOD: Jan 2021-May 2021. 3. SAMPLE SIZE: 100 participants.
INCLUSION CRITERIA:
- Male and female patients aged 18-60 years with confirmed diagnosis of idiopathic achalasia.
- Patients who are co-operative, can communicate verbally and willing to give informed consent. EXCLUSION CRITERIA:
- Chronic diarrhea, malignancy, severe comorbid illness affecting the nutritional status
- Previously treated and asymptomatic cases with achalasia
- Conditions
- Weight Gain, Nutritional Imbalance
- Being tested
- Per oral endoscopy myotomy
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Per oral endoscopy myotomyProcedure or surgery
Also called POEM
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Per oral endoscopy myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start26 Jan 2021
- Primary completion25 Dec 2021 (estimated)
- Study completion26 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
- Investigators
- Mohan Dr Ramchandani, MBBS MD DNB, Principal investigator, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161923
- Sponsor's protocol ID
- HREM1
- Acronym
- POEM
- Status last verified
- Nov 2021
- First submitted
- 4 Dec 2021
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39158832
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Nutritional Parameters in Patients With Achalasia
- ClinicalTrials.gov ID
- NCT05161923
- Acronym / sponsor ID
- POEM / HREM1
- Conditions
- Weight Gain, Nutritional Imbalance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 25 Dec 2021 (estimated)
- Study completion
- 26 Mar 2022 (estimated)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- .STUDY DESIGN: This study is a Prospective single arm observational study.
- .STUDY PERIOD: Jan 2021-May 2021. 3. SAMPLE SIZE: 100 participants.
INCLUSION CRITERIA:
- Male and female patients aged 18-60 years with confirmed diagnosis of idiopathic achalasia.
- Patients who are co-operative, can communicate verbally and willing to give informed consent. EXCLUSION CRITERIA:
- Chronic diarrhea, malignancy, severe comorbid illness affecting the nutritional status
- Previously treated and asymptomatic cases with achalasia
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Per oral endoscopy myotomy | – | Procedure: Per oral endoscopy myotomyThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 100 patients
Key inclusion criteria (2 listed)
- Male and female patients aged 18-60 years with confirmed diagnosis of idiopathic achalasia.
- Patients who are co-operative, can communicate verbally and willing to give informed consent.
Key exclusion criteria (2 listed)
- Chronic diarrhea, malignancy, severe comorbid illness affecting the nutritional status
- Previously treated and asymptomatic cases with achalasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Per oral endoscopy myotomyAlso: POEMThe 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 or surgery | Per oral endoscopy myotomy |
Primary outcome
To assess the various nutritional indices in cases with treatment ( per oral endoscopic myotomy) failure cases with idiopathic achalasia
Time frame: 12 months
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.
1 secondary outcome
To evaluate the severity of malnutrition before and after undergoing Per-oral endoscopic myotomy (Per Oral Endoscopic Myotomy).
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Derived from this study: PubMed 39158832Nabi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohan Dr Ramchandani, MBBS MD DNB principal investigator
Asian Institute of Gastroenterology, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Gain and Nutritional Imbalance, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zaheer Dr Nabi, MBBS MD DNB (23378888 ext. 040, zaheernabi1978@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the various nutritional indices in cases with treatment ( per oral endoscopic myotomy) failure cases with idiopathic achalasia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05161923, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2021.