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Malnutrition may raise risks during throat surgery, study warns

NCT ID NCT06405412

Knowledge-focused Sponsor: Umraniye Education and Research Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether malnutrition increases the risk of breathing and kidney problems in people with achalasia undergoing POEM surgery. Researchers will track 60 adults for signs like high carbon dioxide levels and kidney stress. The goal is to better understand which patients need extra care before surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors identify malnourished patients at higher risk for breathing or kidney problems during POEM surgery, leading to better pre-surgery care.
What could go wrong
This is a small, observational study (60 people) that only looks for links, not causes. It may not apply to all patients or lead to any change in treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

achalasia Esophageal Achalasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal achalasia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Umraniye Education and Research hospital

    RECRUITING

    Istanbul, 34764, Turkey (Türkiye)

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