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

Not Applicable

Not yet recruiting

• Conditions: MINS; Nephrolithiasis; Myocardial Injury After Noncardiac Surgery; Renal Stones; Myocardial Injury After Noncardiac Surgery (MINS); Percutaneous Nephrolithotomy (PNL); Renal Calculi

• Registration Number: NCT06944301
• Lead Sponsor: Medipol University

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-04-25
• Last Update Posted: 2025-04-25
• Study Start: 2025-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Myocardial Injury after Noncardiac Surgery (MINS)	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 Outcome Measures

Name	Time	Method
Surgical Duration	During surgery.	Time from incision to closure (in minutes).
Postoperative Hospital Stay	From surgery to discharge.	Duration of hospital stay after surgery (in days).