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NCT Number: NCT06405412

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MUST malnutrition score

Other

MUST malnutrition score

Primary outcomes

  1. cardiorespiratory advers events

    Time frame: up to 12 weeks

    hypercapnia (above 45mmHg)

  2. postoperative renal complications

    Time frame: up to 12 weeks

    serum creatinine 0.3 mg/dL rise

Secondary outcomes

  1. Malnutrition condition

    Time frame: up to 12 weeks

    serum albumin (3.4 to 5.4 g/dL)

  2. escart score

    Time frame: up to 12 weeks

    weight loss ( <5kg to10kg>)

Study contacts

Contact information is provided by the study sponsor or research team.

zeliha tuncel

CONTACT

[email protected]

05053577483

Sponsors and collaborators

Lead sponsor

Umraniye Education and Research Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
May 8, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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