Investigating the impact of malnutrition on breathing and kidney function in achalasia patients undergoing POEM surgery
Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Umraniye Education and Research Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06405412 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-80 diagnosed with achalasia and deemed suitable for POEM treatment.
Not a fit: Patients with severe respiratory or cardiac conditions, significant kidney dysfunction, or other specified exclusions may not benefit from this study.
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 performed: While the specific approach of this study may be novel, similar studies have indicated that addressing malnutrition can significantly impact surgical outcomes.
Eligibility criteria
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 this trial is running
Istanbul
- Umraniye Education and Research hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: zeliha tuncel
- Email: zelihalara@yahoo.com
- Phone: 05053577483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.