Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MUST malnutrition score.
- Who it may be relevant to
- Registry conditions: Esophageal Achalasia. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The hypothesis of this study is to investigate cardiorespiratory and renal complications in patients under general anesthesia undergoing POEM surgery.
Detailed description
The primary purpose of this study is to define mild, medium and severe risk groups for malnutrition by using preoperative albumin values and MUST score in achalasia patients planned for POEM operation, and to determine the relationship of malnutrition/degree as well as demographic characteristics and comorbidities with postoperative respiratory and renal complications.
The secondary aim of this study was to determine persistent respiratory and renal outcome at 3 months after POEM procedure.
Interventions
- Other MUST malnutrition score
MUST malnutrition score
Primary outcome measures
- cardiorespiratory advers events [Time frame: up to 12 weeks]
- postoperative renal complications [Time frame: up to 12 weeks]
Secondary outcome measures (2)
- Malnutrition condition [Time frame: up to 12 weeks]
- escart score [Time frame: up to 12 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Umraniye Education and Research hospital — Istanbul
Identifiers
NCT: NCT06405412 · UERH-AR-ZT-09