ClinicalTrials.gg
RecruitingNCT06405412Updated Nov 19, 2025

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

An observational study in Esophageal Achalasia, sponsored by Umraniye Education and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by Umraniye Education and Research Hospital · Observational

From the registry’s dates

  • Started Nov 2023; still recruiting 3 years later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
60
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Esophageal Achalasia

Browse trials for

Keywords

  • Peroral Endoscopic Myotomy
  • anesthesia
  • Esophageal Achalasia
03

In context

Esophageal Achalasia

143 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.

This study's planned enrollment of 60 is below the median of 111 across 41 observational studies indexed under Esophageal Achalasia.

Browse Esophageal Achalasia studies →

Lead sponsor

Umraniye Education and Research Hospital is the lead sponsor of 61 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Criteria for exclusion from the study:
  • Those with a known history of active lung infection, advanced , 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 >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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

Interventions

  • OtherMUST malnutrition score

    MUST malnutrition score

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2023 to primary completion in Nov 2024, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2024
First posted
May 8, 2024
StartActual
Nov 1, 2023
Primary completionActual
Nov 30, 2024
CompletionEst.
Jul 30, 2026
Last update
Nov 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06405412
Lead sponsor
Umraniye Education and Research Hospital
Responsible party
Zeliha Alicikus (Chief Anesthesiologist, Umraniye Education and Research Hospital) — Principal investigator
First posted
May 8, 2024
Start date
Nov 1, 2023
Primary completion
Nov 30, 2024
Completion
Jul 30, 2026 (estimated)
Last update
Nov 19, 2025

Study contacts

zeliha tuncel
Contact
zelihalara@yahoo.com
05053577483

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion