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

April 23, 2025 updated by: Ali Ihsan Memmi, Medipol University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ali İhsan Memmi, Medical Doctor
  • Phone Number: +90 537 9220997
  • Email: alimemmi@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Supine PNL
Patients undergoing PNL in the supine position.
Diagnostic test: blood sampling
measuring troponine preoperative and postoperative first and second day
Other: Prone PNL
Patients undergoing PNL in the prone position.
Diagnostic test: blood sampling
measuring troponine preoperative and postoperative first and second day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 48 hours post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Duration
Time Frame: During surgery.
Time from incision to closure (in minutes).
During surgery.
Postoperative Hospital Stay
Time Frame: From surgery to discharge.
Duration of hospital stay after surgery (in days).
From surgery to discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Collaborators

Istanbul Medipol University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3211789

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect patient privacy. Aggregated data may be published in scientific journals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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