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Comparison of Myocardial Injury After Noncardiac Surgery (MINS) Incidence in Supine vs. Prone Positioning During Percutaneous Nephrolithotomy (PNL)

M

Medipol University

Status

Begins enrollment this month

Conditions

Percutaneous Nephrolithotomy (PNL)
Myocardial Injury After Noncardiac Surgery
Renal Stones
Renal Calculi
MINS
Nephrolithiasis
Myocardial Injury After Noncardiac Surgery (MINS)

Treatments

Diagnostic Test: blood sampling

Study type

Interventional

Funder types

Other

Identifiers

NCT06944301
3211789

Details and patient eligibility

About

This prospective cohort study aims to compare the incidence of Myocardial Injury after Noncardiac Surgery (MINS) in patients undergoing percutaneous nephrolithotomy (PNL) for kidney stones in supine versus prone positioning. MINS is defined as an elevated postoperative troponin level (≥0.03 ng/mL) within 48 hours after surgery. Approximately 400 patients will be enrolled, with 200 patients in each positioning group (supine and prone). The primary outcome is the incidence of MINS, assessed through troponin measurements and electrocardiogram (ECG) findings. Secondary outcomes include intraoperative complications, duration of surgery, and postoperative recovery metrics. The study seeks to determine whether surgical positioning impacts MINS risk, potentially guiding safer surgical practices.

Full description

Myocardial Injury after Noncardiac Surgery (MINS) is a significant perioperative complication associated with increased morbidity and mortality. This study investigates whether surgical positioning (supine vs. prone) during percutaneous nephrolithotomy (PNL) influences the incidence of MINS. Patients aged 18 years and older undergoing PNL for kidney stones will be enrolled in a prospective cohort study at [Institution Name]. Exclusion criteria include pre-existing cardiovascular disease, elevated baseline troponin levels, or major intraoperative complications. Approximately 400 patients will be divided into two groups based on surgical positioning: 200 in the supine group and 200 in the prone group. Troponin levels will be measured preoperatively and at 24 and 48 hours postoperatively, with MINS defined as a troponin T level ≥0.03 ng/mL. Electrocardiograms (ECGs) will be performed to detect ischemic changes. Secondary outcomes include intraoperative hypotension, surgical duration, and postoperative hospital stay. Data will be analyzed using chi-square tests and logistic regression to adjust for confounders such as age, comorbidities, and surgical duration. The study aims to provide evidence on the impact of positioning on MINS, potentially informing safer surgical protocols for PNL.

Enrollment

400 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥40 years.
  • Patients undergoing percutaneous nephrolithotomy (PNL) for kidney stones.
  • Willing and able to provide informed consent.

Exclusion criteria

  • Known coronary artery disease, heart failure, or other significant cardiovascular conditions.
  • Elevated preoperative troponin levels (≥0.03 ng/mL).
  • Major intraoperative complications (e.g., severe bleeding requiring transfusion).
  • Inability to comply with study procedures.

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 2 patient groups

Supine PNL
Other group
Description:
Patients undergoing PNL in the supine position.
Treatment:
Diagnostic Test: blood sampling
Prone PNL
Other group
Description:
Patients undergoing PNL in the prone position.
Treatment:
Diagnostic Test: blood sampling

Trial contacts and locations

0

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Central trial contact

Ali İhsan Memmi, Medical Doctor

Data sourced from clinicaltrials.gov

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