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

Recruiting

• Conditions: Esophageal Achalasia
• Interventions: Other: MUST malnutrition score

• Registration Number: NCT06405412
• Lead Sponsor: Umraniye Education and Research Hospital

Brief Summary

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.

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-08
• Primary Completion: 2024-11-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-12
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild malnutrition	MUST malnutrition score	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)
Severe malnutrition	MUST malnutrition score	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)
Moderate malnutrition	MUST malnutrition score	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)

Primary Outcome Measures

Name	Time	Method
cardiorespiratory advers events	up to 12 weeks	hypercapnia (above 45mmHg)
postoperative renal complications	up to 12 weeks	serum creatinine 0.3 mg/dL rise

Secondary Outcome Measures

Name	Time	Method
escart score	up to 12 weeks	weight loss ( \<5kg to10kg\>)
Malnutrition condition	up to 12 weeks	serum albumin (3.4 to 5.4 g/dL)

Trial Locations

Locations (1)

Umraniye Education and Research hospital; 🇹🇷 Istanbul, Turkey