Laparoscopic CholecystectomyNCT06651450
Electrocardiographic Changes in Cholecystectomy Surgery
An observational study of Laparoscopic Cholecystectomy and Vector Electrocardiography, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic (closed) surgery provides several advantages over open surgery, such as smaller surgical incisions, postoperative recovery, and shorter hospital stay. However, increased intra-abdominal pressure (IAP) during surgery may have adverse effects on some systems such as circulation and respiration. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Vector Electrocardiography
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Patients aged 18-65 who wish to participate in the study and undergo laparoscopic cholecystectomy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, Center, 600100
About this study
Official title: Investigation of Perioperative Electrocardiographic Changes in Laparoscopic Cholecystectomy Surgery
Laparoscopic (closed) surgery provides several advantages over open surgery, such as smaller surgical incisions, postoperative recovery, and shorter hospital stay. However, increased intra-abdominal pressure (IAP) during surgery may have adverse effects on some systems such as circulation and respiration. Increased IAP may reduce blood return to the heart. Some studies have shown that some values calculated from surface electrocardiography are associated with changes in heart rhythm. Changes in blood pressure, nervous, and hormonal systems that may be seen due to increased IAP in laparoscopic surgery may cause arrhythmias in patients.Therefore, researchers aimed to investigate the effects of increased IAP on electrocardiography in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Laparoscopic cholecystectomy has been shown to have advantages such as less postoperative pain, early onset of bowel movements, shortening of hospital stay, early return to daily activities and better aesthetic results compared to open surgery. However, increased intra-abdominal pressure (IAP) can negatively affect the respiratory, circulatory, neuroendocrine and central nervous systems. Increased IAP can compress the vena cava and abdominal aorta, causing deterioration in the perfusion of other organs, especially the kidneys and spleen. In addition, this pathological process reduces the preload of the heart, stroke volume, cardiac output and increases central venous pressure, pulmonary capillary wedge pressure, pulmonary artery pressure and left ventricular afterload. IAP can also affect the pressure in the coronary arteries and impair the nutrition of the heart. It should be noted that increased IAP has also been identified as an independent risk factor for mortality in critically ill patients. The QT interval, which represents the time required for ventricular depolarization and repolarization on the ECG, is the time interval from the beginning of the QRS complex to the end of the T wave. Since the Qt interval is affected by the heart rate, it is called QT corrected according to the heart rate, QTc. Prolongation of the peroperative QT and QTc intervals can result in serious complications such as serious arrhythmias, ventricular tachycardia, ventricular fibrillation, and cardiac arrest. Variable QT intervals have been associated with heterogeneous repolarization and ventricular arrhythmias. The frontal plane QRS-T angle is expressed as the absolute difference between the QRS and T wave axes. The frontal plane QRS-T angle, a parameter that can be easily calculated from the 12-lead surface ECG, is considered a marker of ventricular repolarization heterogeneity. Increased ventricular repolarization heterogeneity is associated with an increased risk of arrhythmogenesis. Studies have shown that increased frontal plane QRS-T angle leads to an increased risk of cardiovascular and arrhythmic events and is associated with an increased risk of mortality. Previous publications have reported that the frontal plane QRS-T angle value is stronger, more renewable, and less affected by external factors than the QT/QTc value in showing ventricular repolarization. A wider frontal plane QRS-T angle is considered a strong and independent risk indicator for cardiac morbidity and mortality compared to other traditional cardiovascular risk factors such as the length of the QT interval and electrocardiographic risk indicators. The increase in IAP in laparoscopic surgeries, anesthetic drugs, patient positions, and neuroendocrine response may increase the risk of arrhythmia in the patient. There are many studies on the effects of laparoscopic surgeries, anesthetic drugs, and anesthesia methods that increase IAP on the QT/QTc duration, and there are a limited number of studies in the literature on the effects of another repolarization parameter, the frontal plane QRS-T angle. In this study, researchers investigated perioperative frontal QRS-T angle change and risk of arrhythmia predisposition in patients undergoing laparoscopic cholecystectomy under general anesthesia.
- Keywords
- Electrocardiography, general anesthesia, pneumoperitoneum, vectorcardiography, cardiac arrhythmias
- Medical subject headings
- Pneumoperitoneum, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent laparoscopic cholecystectomy surgery | Effects of increasing IAB on frontal plane QRS-T angle, QT and QTc in ECG at different stages of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
frontal plane QRS-T angle, QT and QTc interval
The frontal plane QRS-T angle, which is accepted as the ventricular repolarization parameter, describes the angle between the QRS and T axes calculated from the surface ECG.The QT interval, which represents the time required for ventricular depolarization and repolarization on the ECG, is the time interval from the beginning of the QRS complex to the end of the T wave.
Measured: EECG recordings will be taken immediately before surgery, before and immediately after intra-abdominal CO2 insufflation, 2 minutes after reverse Trendelenburg, immediately after the patient is awakened, and at the 2nd hour after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Sep 2024
- Primary completion1 Mar 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Genc, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651450
- Sponsor's protocol ID
- 24-KAEK-215
- Status last verified
- Aug 2025
- First submitted
- 16 Oct 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Genc A, Ozsoy U, Sahin AT, Gurler Balta M, Kolukcu V, Genc Tapar G, Karaman T, Karaman S. Intra-abdominal hypertension and reverse Trendelenburg position increase frontal QRS-T angle in laparoscopic cholecystectomy: An observational study. Medicine (Baltimore). 2025 Mar 14;104(11):e41934. doi: 10.1097/MD.0000000000041934.
PubMed 40101078
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Perioperative Electrocardiographic Changes in Laparoscopic Cholecystectomy Surgery
- ClinicalTrials.gov ID
- NCT06651450
- Acronym / sponsor ID
- 24-KAEK-215
- Keywords
- Electrocardiography, general anesthesia, pneumoperitoneum, vectorcardiography, cardiac arrhythmias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic (closed) surgery provides several advantages over open surgery, such as smaller surgical incisions, postoperative recovery, and shorter hospital stay. However, increased intra-abdominal pressure (IAP) during surgery may have adverse effects on some systems such as circulation and respiration. Increased IAP may reduce blood return to the heart. Some studies have shown that some values calculated from surface electrocardiography are associated with changes in heart rhythm. Changes in blood pressure, nervous, and hormonal systems that may be seen due to increased IAP in laparoscopic surgery may cause arrhythmias in patients.Therefore, researchers aimed to investigate the effects of increased IAP on electrocardiography in patients undergoing laparoscopic cholecystectomy.
Detailed description
Laparoscopic cholecystectomy has been shown to have advantages such as less postoperative pain, early onset of bowel movements, shortening of hospital stay, early return to daily activities and better aesthetic results compared to open surgery. However, increased intra-abdominal pressure (IAP) can negatively affect the respiratory, circulatory, neuroendocrine and central nervous systems. Increased IAP can compress the vena cava and abdominal aorta, causing deterioration in the perfusion of other organs, especially the kidneys and spleen. In addition, this pathological process reduces the preload of the heart, stroke volume, cardiac output and increases central venous pressure, pulmonary capillary wedge pressure, pulmonary artery pressure and left ventricular afterload. IAP can also affect the pressure in the coronary arteries and impair the nutrition of the heart. It should be noted that increased IAP has also been identified as an independent risk factor for mortality in critically ill patients. The QT interval, which represents the time required for ventricular depolarization and repolarization on the ECG, is the time interval from the beginning of the QRS complex to the end of the T wave. Since the Qt interval is affected by the heart rate, it is called QT corrected according to the heart rate, QTc. Prolongation of the peroperative QT and QTc intervals can result in serious complications such as serious arrhythmias, ventricular tachycardia, ventricular fibrillation, and cardiac arrest. Variable QT intervals have been associated with heterogeneous repolarization and ventricular arrhythmias. The frontal plane QRS-T angle is expressed as the absolute difference between the QRS and T wave axes. The frontal plane QRS-T angle, a parameter that can be easily calculated from the 12-lead surface ECG, is considered a marker of ventricular repolarization heterogeneity. Increased ventricular repolarization heterogeneity is associated with an increased risk of arrhythmogenesis. Studies have shown that increased frontal plane QRS-T angle leads to an increased risk of cardiovascular and arrhythmic events and is associated with an increased risk of mortality. Previous publications have reported that the frontal plane QRS-T angle value is stronger, more renewable, and less affected by external factors than the QT/QTc value in showing ventricular repolarization. A wider frontal plane QRS-T angle is considered a strong and independent risk indicator for cardiac morbidity and mortality compared to other traditional cardiovascular risk factors such as the length of the QT interval and electrocardiographic risk indicators. The increase in IAP in laparoscopic surgeries, anesthetic drugs, patient positions, and neuroendocrine response may increase the risk of arrhythmia in the patient. There are many studies on the effects of laparoscopic surgeries, anesthetic drugs, and anesthesia methods that increase IAP on the QT/QTc duration, and there are a limited number of studies in the literature on the effects of another repolarization parameter, the frontal plane QRS-T angle. In this study, researchers investigated perioperative frontal QRS-T angle change and risk of arrhythmia predisposition in patients undergoing laparoscopic cholecystectomy under general anesthesia.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent laparoscopic cholecystectomy surgery | – | –Effects of increasing IAB on frontal plane QRS-T angle, QT and QTc in ECG at different stages of surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (1 listed)
- Patients aged 18-65 who wish to participate in the study and undergo laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
frontal plane QRS-T angle, QT and QTc interval
Time frame: EECG recordings will be taken immediately before surgery, before and immediately after intra-abdominal CO2 insufflation, 2 minutes after reverse Trendelenburg, immediately after the patient is awakened, and at the 2nd hour after surgery.
The frontal plane QRS-T angle, which is accepted as the ventricular repolarization parameter, describes the angle between the QRS and T axes calculated from the surface ECG.The QT interval, which represents the time required for ventricular depolarization and repolarization on the ECG, is the time interval from the beginning of the QRS complex to the end of the T wave.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Derived from this study: PubMed 40101078Genc A, Ozsoy U, Sahin AT, Gurler Balta M, Kolukcu V, Genc Tapar G, Karaman T, Karaman S. Intra-abdominal hypertension and reverse Trendelenburg position increase frontal QRS-T angle in laparoscopic cholecystectomy: An observational study. Medicine (Baltimore). 2025 Mar 14;104(11):e41934. doi: 10.1097/MD.0000000000041934.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Cholecystectomy and Vector Electrocardiography, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frontal plane QRS-T angle, QT and QTc interval (time frame: EECG recordings will be taken immediately before surgery, before and immediately after intra-abdominal CO2 insufflation, 2 minutes after reverse Trendelenburg, immediately after the patient is awakened, and at the 2nd hour after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06651450, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.