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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUmraniye Education and Research Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with achalasia and suitable for POEM treatment by gastroenterology physicians

ASA 1-3

Between the ages of 18-80

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • MUST malnutrition score

    Other intervention

    MUST malnutrition score

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Mild malnutrition1 intervention
Group B: Moderate malnutrition1 intervention
Group C: Severe malnutrition1 intervention

Trial outcomes

Primary outcomes

1

cardiorespiratory advers events

hypercapnia (above 45mmHg)

Time frame
up to 12 weeks
2

postoperative renal complications

serum creatinine 0.3 mg/dL rise

Time frame
up to 12 weeks

Secondary outcomes

1

Malnutrition condition

serum albumin (3.4 to 5.4 g/dL)

Time frame
up to 12 weeks
2

escart score

weight loss ( \<5kg to10kg\>)

Time frame
up to 12 weeks

Other outcomes

Sponsors and contacts

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