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Heart rhythm changes during keyhole gallbladder surgery under the microscope

NCT ID NCT06651450

Knowledge-focused Sponsor: Tokat Gaziosmanpasa University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at how increased belly pressure during laparoscopic (keyhole) gallbladder surgery affects the heart's electrical activity. Researchers measured ECG changes in 48 patients aged 18-65 who had no heart or serious health conditions. The goal was to understand if the surgery itself can cause heart rhythm changes.

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 could help doctors better monitor heart risks during laparoscopic gallbladder surgery.
What could go wrong
This is a small, completed observational study with only 48 patients. It does not test a treatment, so it cannot directly lead to a cure or therapy.

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

48 people

The number who actually took part.

Started

Sep 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

People between the ages of 18-65 who are scheduled to undergo laparoscopic cholecystectomy are included in the study. When calculating the sample size; when the effect size obtained from the previous study was accepted as 0.4, the type 1 error value as 0.05, and the power as 0.80, it was determined that the sample size for the study was sufficient with 44 patients. Considering the losses that may occur during follow-up, it was planned to conduct the study with 48 patients with a 10% increase.

Ages

18 to 65 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: * Patients aged 18-65 who wish to participate in the study and undergo laparoscopic cholecystectomy Exclusion Criteria: * Cardiovascular diseases (coronary artery disease, atrial fibrillation, atrial flutter, heart failure, pacemaker, ICD, CRT, bundle branch block) * Serious respiratory diseases * Electrolyte disorders * Renal failure * Metabolic diseases * Advanced psychiatric diseases

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac Pneumoperitoneum

As listed by the trial registrant

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

Laparoscopic cholecystectomy Vector electrocardiography

Contacts and locations

Locations

  • Tokat Gaziosmanpasa University

    Tokat Province, Center, 600100, Turkey (Türkiye)

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