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Clinical Trials/NCT06405412
NCT06405412
Recruiting
Not Applicable

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

Umraniye Education and Research Hospital1 site in 1 country60 target enrollmentNovember 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Esophageal Achalasia
Sponsor
Umraniye Education and Research Hospital
Enrollment
60
Locations
1
Primary Endpoint
cardiorespiratory advers events
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
July 30, 2026
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Umraniye Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Zeliha Alicikus

Chief Anesthesiologist

Umraniye Education and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Criteria for inclusion in the study:
  • Patients diagnosed with achalasia and suitable for POEM treatment by gastroenterology physicians
  • 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

Outcomes

Primary Outcomes

cardiorespiratory advers events

Time Frame: up to 12 weeks

hypercapnia (above 45mmHg)

postoperative renal complications

Time Frame: up to 12 weeks

serum creatinine 0.3 mg/dL rise

Secondary Outcomes

  • Malnutrition condition(up to 12 weeks)
  • escart score(up to 12 weeks)

Study Sites (1)

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