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

NCT ID: NCT06944301

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-08-01

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Supine PNL

Patients undergoing PNL in the supine position.

Group Type: OTHER

blood sampling

Intervention Type: DIAGNOSTIC_TEST

measuring troponine preoperative and postoperative first and second day

Prone PNL

Patients undergoing PNL in the prone position.

Group Type: OTHER

blood sampling

Intervention Type: DIAGNOSTIC_TEST

measuring troponine preoperative and postoperative first and second day

Interventions

blood sampling

measuring troponine preoperative and postoperative first and second day

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: collaborator

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Ali Ihsan Memmi

medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ali İhsan Memmi, Medical Doctor

Role: CONTACT

alimemmi@gmail.com

+90 537 9220997

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Other Identifiers

3211789

Identifier Type: -

Identifier Source: org_study_id