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

Achalasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06405412
• Other study ID #: UERH-AR-ZT-09
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2024
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 purpose of this study is to determine the permanent postoperative respiratory and renal complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 30, 2024
• Est. primary completion date: April 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 hypovolemia History 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.

Related Conditions & MeSH terms

• Achalasia
• Esophageal Achalasia
• Malnutrition

Intervention

Other:
• MUST malnutrition score
MUST malnutrition score

Locations

Country	Name	City	State
Turkey	Umraniye Education and Research hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between malnutrition and postoperative cardiorespiratory and renal complications	The primary purpose of the 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.	3 months