NCT06502340

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

July 15, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

July 9, 2024

Last Update Submit

July 16, 2024

Conditions

Myocard Injury After Non Cardiac SurgeryRobotic Assisted Laparoscopic Radical Prostatectomy

Outcome Measures

Primary Outcomes (3)

  • high-sensitive Troponin I levels

    preoperative

  • high-sensitive Troponin I levels

    postoperative 24th hour

  • high-sensitive Troponin I levels

    postoperative 48th hour

Study Arms (1)

patient

All patients who will undergo elective robotic-assisted laparoscopic radical prostatectomy

Diagnostic Test: high sensitive troponin I

Interventions

high sensitive troponin IDIAGNOSTIC_TEST

high-sensitive Troponin I levels

patient

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

high-sensitive Troponin I

Central Study Contacts

Betül Güven Aytaç assoc. prof

CONTACT

+90 312 552 60 00drbguven@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc. prof

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 16, 2024

Study Start

July 15, 2024

Primary Completion

September 1, 2024

Study Completion

December 30, 2024

Last Updated

July 18, 2024

Record last verified: 2024-07