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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06405412

Enrollment

Registered

2024-05-08

Start date

2023-11-01

Completion date

2026-07-30

Last updated

2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Achalasia

Keywords

Peroral Endoscopic Myotomy, anesthesia, Esophageal Achalasia

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.

Interventions

OTHERMUST malnutrition score

MUST malnutrition score

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Turkey (Türkiye)

Contacts

Primary Contactzeliha tuncel

zelihalara@yahoo.com05053577483

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026