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

November 16, 2025 updated by: Zeliha Alicikus, Umraniye Education and Research Hospital
The hypothesis of this study is to investigate cardiorespiratory and renal complications in patients under general anesthesia undergoing POEM surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
MUST malnutrition score

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiorespiratory advers events
Time Frame: up to 12 weeks
hypercapnia (above 45mmHg)
up to 12 weeks
postoperative renal complications
Time Frame: up to 12 weeks
serum creatinine 0.3 mg/dL rise
up to 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umraniye Education and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

November 30, 2024

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UERH-AR-ZT-09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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