PERIOPERATIVE MYOCARDIAL DAMAGE IN ROBOT-ASSISTED SURGERY | NCT06502340

Studies
PERIOPERATIVE MYOCARDIAL DAMAGE IN ROBOT-ASSISTED SURGERY

NCT06502340

Sponsor

Ankara City Hospital Bilkent

Status

Completed

Last Update Posted

Jun 16, 2026Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Myocard Injury After Non Cardiac Surgery
Robotic Assisted Laparoscopic Radical Prostatectomy

Interventions

high sensitive troponin I

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2024Actual

Primary Completion Date

Sep 1, 2024Actual

Completion Date

Dec 30, 2024Actual

First Submitted Date

Jul 9, 2024

First Submission Date that Met QC Criteria

Jul 9, 2024

First Posted Date

Jul 16, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2026

Last Update Posted Date

Jun 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient		All patients who will undergo elective robotic-assisted laparoscopic radical prostatectomy	Diagnostic Test: high sensitive troponin I

Interventions

Name	Type	Description	Arm Group Labels	Other Names
high sensitive troponin I	Diagnostic Test	high-sensitive Troponin I levels	patient

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara Bilkent City Hospital		Ankara			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided