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NCT Number: NCT06944301

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sampling

Diagnostic Test

measuring troponine preoperative and postoperative first and second day

Primary outcomes

  1. Incidence of Myocardial Injury after Noncardiac Surgery (MINS)

    Time frame: Up to 48 hours post-surgery

    Proportion of patients with postoperative troponin T levels ≥0.03 ng/mL within 48 hours after PNL, confirmed by ECG findings if ischemic changes are present.

Secondary outcomes

  1. Surgical Duration

    Time frame: During surgery.

    Time from incision to closure (in minutes).

  2. Postoperative Hospital Stay

    Time frame: From surgery to discharge.

    Duration of hospital stay after surgery (in days).

Study contacts

Contact information is provided by the study sponsor or research team.

Ali İhsan Memmi, Medical Doctor

CONTACT

[email protected]

+90 537 9220997

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Collaborators

  • Istanbul Medipol University Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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