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Search / Trial NCT06405412

Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)

Launched by UMRANIYE EDUCATION AND RESEARCH HOSPITAL · May 6, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Peroral Endoscopic Myotomy Anesthesia Esophageal Achalasia

ClinConnect Summary

This clinical trial is studying how malnutrition affects breathing and kidney functions in patients with a condition called esophageal achalasia. Achalasia makes it difficult for food to pass from the esophagus to the stomach, and the trial is focused on patients undergoing a specific type of surgery known as peroral endoscopic myotomy (POEM) while under general anesthesia. The researchers want to understand if being malnourished can lead to complications during and after the surgery.

To participate in this study, you need to be between 18 and 80 years old and diagnosed with achalasia, meaning your doctors believe you're a good candidate for the POEM procedure. However, certain health conditions like severe lung disease, heart issues, or severe kidney problems may exclude you from joining the trial. If you are eligible, you will undergo the POEM surgery and be monitored for any signs of respiratory or kidney problems following the procedure. This study aims to enhance patient safety and improve care for those undergoing this surgery.

Gender

ALL

Eligibility 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.

About Umraniye Education And Research Hospital

Umraniye Education and Research Hospital is a leading healthcare institution dedicated to advancing medical research and education. Located in Istanbul, Turkey, the hospital is renowned for its commitment to providing high-quality patient care while fostering innovation in clinical trials. As a clinical trial sponsor, Umraniye Education and Research Hospital emphasizes ethical standards, rigorous scientific methodology, and collaboration with healthcare professionals and researchers. The institution aims to contribute to the development of new therapies and improve health outcomes through its robust research programs and a multidisciplinary approach to clinical studies.

Locations

Istanbul, , Turkey

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported