Investigating the impact of malnutrition on breathing and kidney function in achalasia patients undergoing POEM surgery
Official title: Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)
Run by Umraniye Education and Research Hospital · NCT06405412 · Data updated 2026-11-12
This study is testing how malnutrition affects breathing and kidney health in patients with achalasia who are having a specific surgery called POEM.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Umraniye Education and Research Hospital Government |
| Locations | 1 site (Istanbul) |
| Status | Recruiting |
| Started | November 1, 2023 |
| Main results expected | November 30, 2024 |
| Study ends | July 30, 2026 |
| Registry record updated | November 19, 2025 |
| Trial ID | NCT06405412 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18-80 diagnosed with achalasia and deemed suitable for POEM treatment.
✕Probably not a fit
Patients with severe respiratory or cardiac conditions, significant kidney dysfunction, or other specified exclusions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the effects of malnutrition on respiratory and renal complications in patients with esophageal achalasia undergoing peroral endoscopic myotomy (POEM). It will categorize patients into risk groups based on preoperative albumin levels and the Malnutrition Universal Screening Tool (MUST) score. The study will also explore the relationship between malnutrition severity, demographic factors, and comorbidities with postoperative complications. Additionally, it will evaluate the long-term respiratory and renal outcomes three months after the POEM procedure.
Why it matters
Potential benefit: If successful, this study could help identify at-risk patients and improve postoperative care for those undergoing POEM surgery.
How similar studies have gone: While the specific approach of this study may be novel, similar studies have indicated that addressing malnutrition can significantly impact surgical outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Criteria for inclusion in the study: * Patients diagnosed with achalasia and suitable for POEM treatment by gastroenterology physicians * ASA 1-3 * Between the ages of 18-80 Exclusion Criteria: * Criteria for exclusion from the study: * Those with a known history of active lung infection, advanced COPD, or respiratory failure * Patients with EF below 40%, severe ischemic heart failure, presence of valve disease * Those with bleeding diathesis and severe thrombocytopenia (limit 30-50 thousand) * severe kidney dysfunction * In the presence of known intolerance or allergy to certain medications for sedation, analgesia, or both * Pre-existing increased intracranial pressure * Having a BMI \>30 * Severe uncorrected hypovolemiaHistory of radiotherapy to the esophagus * History of mucosal resection or ablation in the area where POEM will be applied * Presence of cirrhosis and portal hypertension.
Where it's running
-
Umraniye Education and Research hospital
Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: zeliha tuncel
- Email: zelihalara@yahoo.com
- Phone: 05053577483
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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POEM vs Heller myotomy with Dor fundoplication for achalasia
This trial tests POEM against laparoscopic Heller myotomy with Dor fundoplication to see which procedure better helps adults with achalasia.
-
Comparing Botox and surgery for stomach drainage during esophagectomy
This study is testing whether Botox injections can help people who have had esophagus surgery manage delayed stomach emptying just as well as surgery can.
-
Evaluating esophageal clearance in achalasia using advanced imaging techniques
This study is testing if a new way to measure how well the esophagus clears food can replace an older method that uses radiation for patients with achalasia who have had a specific surgery.
-
Comparing routine and symptom-based PPI therapy after a procedure for esophageal achalasia
This study is testing whether giving patients with esophageal achalasia a routine 12-month prescription for heartburn medication after a specific procedure can help prevent throat inflammation better than only giving the medication when they have symptoms.
-
New treatments for esophageal achalasia
This study is testing four different treatment options for esophageal achalasia to see which one helps patients feel better, especially those who haven't had success with other treatments.
-
Registry for identifying risk factors of esophageal cancer
This study is trying to find out if certain blood and tissue markers can help identify people at risk for esophageal cancer by looking at their medical history and samples.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.