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

NCT06405412 | Recruiting

• 1 other identifier: UERH-AR-ZT-09
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Achalasia

Keywords

Peroral Endoscopic Myotomy; anesthesia; Esophageal Achalasia

Outcome Measures

Primary Outcomes (2)

• cardiorespiratory advers events

  hypercapnia (above 45mmHg)

  up to 12 weeks

• postoperative renal complications

  serum creatinine 0.3 mg/dL rise

  up to 12 weeks

Secondary Outcomes (2)

• Malnutrition condition

  up to 12 weeks

• escart score

  up to 12 weeks

Study Arms (3)

Mild malnutrition

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)

Other: MUST malnutrition score

Moderate malnutrition

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)

Other: MUST malnutrition score

Severe malnutrition

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)

Other: MUST malnutrition score

Interventions

MUST malnutrition score OTHER

MUST malnutrition score

Mild malnutrition; Moderate malnutrition; Severe malnutrition

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this retrospective cohort study, 50 patients diagnosed with achalasia who applied to the Gastroenterology department of Ümraniye Training and Research Hospital between October 2021 and February 2024 and were indicated for POEM treatment will be included.

You may qualify if:

• Patients diagnosed with achalasia and suitable for POEM treatment by gastroenterology physicians
• ASA 1-3
• Between the ages of 18-80

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Education and Research hospital

Istanbul, 34764, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

zeliha tuncel

CONTACT

05053577483; zelihalara@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Anesthesiologist

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 8, 2024
• Study Start: November 1, 2023
• Primary Completion: November 30, 2024
• Study Completion (Estimated): July 30, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Locations

TU (1)