Actively Recruiting
Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)
Led by Umraniye Education and Research Hospital · Updated on 2025-11-19
60
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the impact of malnutrition on respiratory and kidney complications in patients undergoing peroral endoscopic myotomy (POEM) surgery for esophageal achalasia. The study aims to classify patients into mild, moderate, and severe malnutrition risk groups using preoperative albumin levels and the MUST malnutrition score. It also examines how malnutrition severity, demographic factors, and other health conditions relate to complications after surgery. Participants will be grouped based on their MUST malnutrition scores, which assess body mass index, weight loss, and feeding difficulties before surgery. The study categorizes patients into three malnutrition severity groups: mild, moderate, and severe. These groupings allow researchers to compare outcomes related to respiratory and kidney function following the POEM procedure. Throughout the study, participants will be monitored for up to 12 weeks after surgery to track respiratory and renal complications. Researchers will assess malnutrition status and use the escart score during this period. The study also plans to evaluate longer-term respiratory and kidney outcomes at 3 months post-procedure, with assessments including clinical evaluations and laboratory tests to understand the relationship between malnutrition and postoperative recovery.
CONDITIONS
Brief Title
Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with achalasia and suitable for POEM treatment by gastroenterology physicians
- ASA physical status classification 1 to 3
- Between 18 and 80 years old
You will not qualify if you...
- Known history of active lung infection, advanced COPD, or respiratory failure
- Ejection fraction below 40%, severe ischemic heart failure, or valve disease
- Bleeding disorders or severe thrombocytopenia (platelets 30-50 thousand)
- Severe kidney dysfunction
- Known intolerance or allergy to sedation or analgesia medications
- Pre-existing increased intracranial pressure
- Body mass index greater than 30
- Severe uncorrected low blood volume
- History of radiotherapy to the esophagus
- Previous mucosal resection or ablation in the POEM treatment area
- Presence of cirrhosis and portal hypertension
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week before surgery
Participants undergo preoperative assessment including MUST malnutrition scoring to classify malnutrition risk before the POEM procedure.
1 visit (in-person)
Duration - Up to 1 week
Participants undergo the peroral endoscopic myotomy (POEM) procedure and receive immediate post-operative care.
1 surgical visit and approximately 1 follow-up visit during immediate recovery
Duration - Up to 12 weeks
Participants are monitored for respiratory and renal complications after surgery and malnutrition condition is assessed.
Approximately 3 visits over 12 weeks
Trial Site Locations
Total: 1 location
1
Umraniye Education and Research hospital
Istanbul, Turkey (Türkiye), 34764
Actively Recruiting
Research Team
Z
zeliha tuncel
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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