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

Umraniye Education and Research Hospital

Status: Enrolling

Conditions: Esophageal Achalasia

Treatments: Other: MUST malnutrition score

Study type: Observational

Funder types: Other

Identifiers

NCT06405412

UERH-AR-ZT-09

Details and patient eligibility

About

The hypothesis of this study is to investigate cardiorespiratory and renal complications in patients under general anesthesia undergoing POEM surgery.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 3 patient groups

Mild malnutrition

Description:

Patients will be divided into 3 groups according to the MUST malnutrition score in the preoperative period (BMI, weight loss, acute illness/oral feeding difficulty). (mild, moderate, severe malnutrition)

Treatment:

Other: MUST malnutrition score

Moderate malnutrition

Description:

Patients will be divided into 3 groups according to the MUST malnutrition score in the preoperative period (BMI, weight loss, acute illness/oral feeding difficulty). (mild, moderate, severe malnutrition)

Treatment:

Other: MUST malnutrition score

Severe malnutrition

Description:

Patients will be divided into 3 groups according to the MUST malnutrition score in the preoperative period (BMI, weight loss, acute illness/oral feeding difficulty). (mild, moderate, severe malnutrition)

Treatment:

Other: MUST malnutrition score