PERIOPERATIVE MYOCARDIAL DAMAGE IN ROBOT-ASSISTED SURGERY

July 16, 2024 updated by: Betül Güven, Ankara City Hospital Bilkent

ASSESSMENT OF PERIOPERATIVE MYOCARDIAL DAMAGE IN ROBOT-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMIES

Our study aimed to identify myocardial damage during or after robotic-assisted radical prostatectomy by measuring high-sensitive Troponin I levels, which are the most sensitive and effective according to the AHA/ACC guideline. The study's secondary objective was to establish which parameters were associated with myocardial damage.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

63

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: Betül Güven Aytaç assoc. prof
  • Phone Number: +90 312 552 60 00
  • Email: drbguven@hotmail.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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients undergoing elective robotic-assisted laparoscopic radical prostatectomy will be included in the study.

Description

Inclusion Criteria:

  • Patients who will undergo elective robotic surgery
  • Patients with I, II, and III according to ASA classification
  • Those with body mass index (BMI) below 35kg/m2
  • Patients whose consent was obtained before the procedure

Exclusion Criteria:

  • Patients who were converted to open surgery for any reason
  • patients who did not agree to participate in the research

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient
All patients who will undergo elective robotic-assisted laparoscopic radical prostatectomy
Diagnostic test: high sensitive troponin I
high-sensitive Troponin I levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
high-sensitive Troponin I levels
Time Frame: preoperative
preoperative
high-sensitive Troponin I levels
Time Frame: postoperative 24th hour
postoperative 24th hour
high-sensitive Troponin I levels
Time Frame: postoperative 48th hour
postoperative 48th hour

Collaborators and Investigators

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

Sponsor

Ankara City Hospital Bilkent

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)

July 15, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • E2-23-5211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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